Implants Review and Outlook

SPECIAL REPORT JUNE 2011

Implants Review AND Outlook

Worldwide implants market continues to grow, lead by the U.S.

The U.S. implantable medical device market is forecasted to grow more than 8% per year and is on pace to exceed $50 billion in 2015. Growth in this sector is anticipated to remain strong despite continuing product recalls and safety controversies, particularly in the cardiac implant segment. Next-generation devices centered around new technologies and improved materials will help propel market growth. New technologies will also lessen the thrombosis risk of drug-eluting coronary stents. There is expected to be an uprise in new implantable devices for the treatment and management of cardiovascular, orthopedic, neurological, ophthalmic and various other chronic disorders as existing products are lacking in many areas. Biodegradable medical implants represent a fast-growing field. Biomaterials are used in various types of orthopedic surgical situations such as joint replacements, fracture-fixation plates, bone- defect fillers, artificial tendons, as well as ligaments and bone cements. One of the leading orthopedic R&D areas is materials development. This segment includes orthobiologics, resorbable materials, and materials that increase wear resistance for joint replacements. Through such materials, many companies are developing implants that will provide better durability than present alternatives. Leading U.S. players in the implants segment include Abbott Laboratories, Boston Scientific, Johnson & Johnson and Smith & Nephew. Some of the most innovative companies in the competitive hip and knee sectors are Stryker and Zimmer Holdings. UBM Canon DATA PRODUCTS Table of contents 828B Newtown-Yardley Road, Suite B Newtown, PA 18940 Implant Market Overview ...... 3 United States Implant Companies Review ...... 17 Phone: +1.215.944.9800 Fax: +1.215.867.0053 Implant-Related Rx Drug and Biologic Pipeline ...... 35 Website: PharmaLive.com Awaiting Approval ...... 35 Stephen Corrick Phase III ...... 35 VP and Executive Director UBM Canon Publishing Phase II ...... 3 5 [email protected] Phase I ...... 36 Roger Burg Preclinical ...... 36 VP, Operations Publications Division Developers and Marketers for Implant-Related Rx Drugs/Biologics . . . . 37 [email protected] Implant Devices ...... 3 7 +1.310.445.4221 Class I ...... 37 Glenn Glasberg Class II ...... 106 Circulation and Marketing Director [email protected] Class III ...... 189 +1.215.944.9810 Implant Device Companies ...... 200 Sandra Baker Data Products Manager [email protected] +1.215.944.9836 Review the most recent Special Reports at: www.PharmaLive.com/SpecialReports Amanda Wells Assistant Marketing Manager [email protected] See these and other topics: +1.215.944.9840 POM Quarterly Brandon Materazzi Top 100 Medical Device Companies Marketing Assistant [email protected] Diagnostic Imaging and Monitoring Devices Review and Outlook +1.215.944.9809 Direct-to-Consumer Advertising Review and Outlook Andrew Humphreys Orthopedics Review and Outlook Editor In Chief, Data Products [email protected] Account Rosters: Healthcare Communications Agencies +1.215.944.9812 Investigational Drug Review and Outlook Stefanie Fedder New Drug Review and Outlook Manager, Data and Content New Medical Device Review and Outlook [email protected] +1.215.944.9807 Silvia Arriola eKnowledgeBase – searchable pipeline and business-information database for the Data Specialist [email protected] world’s pharma & biotech companies. Request a trial at: www.PharmaLive.com/newEKB +1.215.944.9803 MDRWeb.com – searchable database of global medical device companies and Diane Strohm their products. Learn more at: www.MDRWeb.com - enter promo code SRTRIAL for Data Specialist [email protected] free two-week trial access. +1.215.944.9828 Andrew Ellison For more information on these products contact: Data Specialist [email protected] or call: +1-215-944-9836 [email protected] +1.215.944.9826

Rebecca Mayer Contributing editor editorial advisors for Special Reports Kim Stannard Production assistant Jay Carter, SVP Director of Strategy Services, AbelsonTaylor Sander Flaum, President, Flaum Partners UBM Ltd. Corporate Head Office Mark Havenhand, MBA, Ph.D., Novartis Pharma AG, Global Head, Ludgate House Business Strategy & Planning Clinical Medical Services 245 Blackfriars Road Boaz Mendzelevski, VP of Cardiology & Chief Medical Officer, London, SE1 9UY, United Kingdom Phone: +44 (0) 20 7921 5000 Medifacts International Website: ubm.com Steven Michaelson, Managing Partner, RosettaWishbone Mike Myers, President, Palio UBM Canon Headquarters 11444 W. Olympic Blvd. David M. Oakley, R.Ph., Ph.D., Director of Technical Development, Los Angeles, CA 90064 AAIPharma United States Deborah Schnell, President, Sales and Strategic Planning, Phone: +1.310.445.4200 Fax: +1.310.445.4299 Healthy Advice Networks Website: ubmcanon.com Marc Weiner, Managing Partner, Ogilvy CommonHealth Worldwide

2 Implants Review and Outlook

Medical implants are devices designed to billion in 2015. Growth in this market is ex- As a result, the number of individuals suf- replace a missing biological structure, en- pected to remain strong despite product fering from degenerative and injured hance an existing biological structure, or recalls and safety controversies, particu- joints, especially deteriorated knees and support a damaged biological structure. larly in the cardiac implant segment, in re- hips, will increase. Implants are commonly made from skin, cent years. These problems experienced Despite product recalls and safety con- bone or other body tissues, or from bio- by implantable cardiac rhythm devices troversies in the cardiac implant segment, medical materials such as titanium and will be balanced out by the development solid growth is projected for this segment silicone. of next-generation devices based on new in the years to come. Analysts predict that Medical implants may be placed in- technologies and improved materials. An- the demand for cardiac implants in the side or on the surface of the body, either alysts also believe that new technologies United States will increase more than 7% permanently or for as long as needed. will lessen the thrombosis risk of drug-elut- each year to almost $18 billion in 2015. Stents and hip implants, for example, are ing coronary stents. Pacing devices are expected to retain intended to be permanent but screws to The industry is expected to see an in- their position as the top-selling group of repair broken bones may be removed crease in the use of implantable devic- cardiac implants because of their various when a patient has recovered. es for the treatment and management indications. Analysts expect growth from Some implants deliver medication in of cardiovascular, orthopedic, neurolog- cardiac resynchronization therapy (CRT) the form of implantable pills or drug-eluting ical, ophthalmic and various other chron- devices for patients afflicted with con- stents, monitor body functions, or provide ic disorders. This is because current prod- gestive heart failure. Implantable cardio- support to organs and tissues such as artifi- ucts simply do not measure up. verter defibrillators (ICDs) are predicted to cial pacemakers and cochlear implants. Industry reports indicate that the de- remain the preferred treatment for tachy- Among the risks associated with medi- mand for orthopedic implants will in- cardia and will likely recapture growth op- cal implants are surgical risks during place- crease almost 9% per year in the United portunities lost in recent times due to prod- ment or removal, infection, implant failure States to about $28 billion in 2015. The four uct recalls. and reactions to the materials used in im- major product segments predicted to ex- Other implantable medical devic- plants. perience the most growth are reconstruc- es are expected to grow about 9% an- Industry analysts strongly believe that tive joint replacements, spinal implants, nually and exceed $6 billion in 2015. This implants, like all devices, will need to trauma implants and orthobiologics. growth will likely be spurred by implant- demonstrate that they provide better Forecast to top $11 billion in 2015, the able stimulators for neurological condi- outcomes and significant cost savings. reconstructive joint replacements market tions, brachytherapy for prostate cancer Industry experts predict that the U.S. im- will continue to experience growth due to indications, cochlear devices for restoring plantable medical devices market will an aging population and the widespread hearing loss, and gastric bands for obesi- grow more than 8% per year to top $50 prevalence of physically active lifestyles. ty intervention. These products offer significant performance and outcome advan- WRIGHT MEDICAL tages versus alternative treatments. Industry analysts believe that the market for total ankle arthroplasty is becoming more viable. Wright Medical Group Inc.’s Inbone II system, the next generation of its total ankle replacement system, became available in the United States as of May 2011. Through its implant modularity and intramedullary-guided instrumentation, the new system gives surgeons more accuracy and reproducibility during procedures. Silicone gel-filled breast implants as well as dermal and tissue implants for cosmetic surgery are also expected to fare well during the next three-to-five years. In- dustry analysts have predicted that the breast implant market will grow 10% a year through 2012. The U.S. breast implant market is projected to reach $620 million in 2012. Growth is expected to be driven in large Source: Wright Medical part by FDA’s reapproval of silicone breast implants. Additionally, fourth-generation 3 silicone breast implants, known as “Gum- Cardica Inc. manufactures stapling Market Leaders my Bear” implants, are predicted to find technologies for use in the heart, and pos- their footing during the next five years and sibly later in 2011, may be expanded to Major competitors in the U.S. implants seg- will further drive market growth. Gummy other surgical indications such as bariatric ment include Abbott Laboratories, Boston Bear implants eliminate the potential for surgery. Cardica has a smaller, more flex- Scientific, Johnson & Johnson and Smith gel migration because of the extremely ible stapler that will allow smaller incisions & Nephew Plc. Additionally, Stryker Corp. cohesive nature of the material inside. for laproscopic surgeries. Additionally, the and Zimmer Holdings Inc. are regarded Silicone breast implants were removed flexible neck on the Cardica stapler will reas the most innovative companies in the from the U.S. market during 1992 be- sult in easier, faster surgeries. intensely competitive hip and knee mar- cause of concerns that leakages could “Although we do not think the staples kets. lead to various connective tissue diseas- for Cardica’s bariatric product themselves Stryker is one of the world’s leading es or cancer. A four-year study of the im- will differ from existing staples, the tech- medical-technology companies, provid- plants, however, determined that the de- nology for delivering the staples is much ing orthopedic implants and medical/ vices are safe for use, which resulted in different,” Dr. Corner says. “We think as surgical equipment. Stryker’s products in- the November 2006 FDA reapproval of Cardica expands its line of staplers that clude implants used in joint replacement, the products. the company will become an acquisition trauma and spinal surgeries; surgical Industry analysts predict that by 2012, target for companies such as Johnson & equipment and surgical navigation sys- nearly 80% of breast implants sold in the Johnson or Covidien Plc. These acquir- tems; endoscopic and communications United States will be silicone. Because ers have larger, less flexible staplers in their systems; patient handling and emergen- these products sell for nearly double that product lines, so Cardica, and Cardica’s cy medical equipment; as well as other of the saline alternative, silicone implant IP, would be a natural target.” medical-device products used in a vari- manufacturers will benefit from increased FDA expanded its approval of Abbott ety of medical specialties. revenue. Laboratories’ Acculink, an artery-open- For first-quarter fiscal 2011, Stryker re- According to Caroline Corner, Ph.D., re- ing stent, to a larger group of patients at ported that profit slid 4.4% due to a hefty search analyst for McNicoll, Lewis & Vlak risk for stroke caused by plaque buildup charge associated with the company’s LLC, continuous glucose monitors (CGM) in the neck arteries during May 2011. The acquisition of Boston Scientific’s neurovas- such as the offerings from Dexcom Inc. regulatory agency approved the Accu- cular business. Revenue grew 12% year- and Medtronic Inc. have gained market link stent as an alternative to a more in- over-year to $2.02 billion, ahead of the traction in recent years. “The idea is that vasive surgical procedure for patients at Zacks Investment Research consensus es- glucose levels can be read continuous- moderate risk of complications from the timate of $2 billion. ly, rather than at discreet points through- surgery. According to analysts with Zacks In- out the day as with fingerstick testing, and Before this regulatory clearance, the vestment Research, Stryker’s sales were hopefully lead to a better diabetes man- stent had only been approved for pa- boosted by sustained double-digit growth agement,” she shares. tients at high risk. Industry analysts report from the company’s surgical equipment A disposable sensor is implanted into that FDA’s approval gives Abbott an unit (MedSurg) coupled with the acquisi- the interstitial fluid beneath the skin and edge over medical-device competitors tion of the neurovascular business, which relays glucose level to an external display such as Boston Scientific Corp., Medtron- offset the lingering softness in its recon- unit. The sensor is replaced every week ic and Johnson & Johnson. structive business. Stryker reported growth or so. in its hips and trauma businesses during first-quarter fiscal 2011, partly offset by a MEDTRONIC decrease in knee sales that were affected by a soft market, according to the analysts. Stryker boasts a well-diversified product portfolio that continues to perform well in a challenging operating environment, according to these analysts. The analysts believe that the company is poised for growth driven by new product launch- es, acquisitions and an improving hospital capital spending backdrop. The company’s MedSurg division continues to generate double-digit growth and has benefited from the Ascent Healthcare acquisition. The introduction of new products, including the hip systems Restoration ADM and MDM X3, are expected to have a positive impact on fiscal-year 2011, according to Zacks Invest- Source: Medtronic ment Research reports. 4 The industry’s continuing transition from orthopedic product development, and formed one of the first implants of the En- metal-on-metal hip implants to next-gen- this has been emphasized in recent invest- ergen ICD with Dong-In Shin, M.D., at the eration hip systems will be favorable for ing activity. University Hospital Dusseldorf in Germa- Stryker, say Zacks Investment Research an- According to Zacks Investment Re- ny. “The small profile, coupled with the alysts. The company’s knee business has search analysts, Stryker still faces stiff 4-SITE connector system, allowed for an struggled in the past few years but the an- challenges from Zimmer Holdings, Smith easy implant with a less pronounced phys- ticipated 2011 approval of OtisMed pre- & Nephew, ConMed Corp, Biomet Inc. ical appearance for the patient.” op surgical cutting guides in the United and Johnson & Johnson’s DePuy Ortho- According to Peter Lecher, M.D., who State should offer a rebound in knee de- paedics Inc. in a highly competitive or- performed one of the first implants of the mand. thopedic industry. Energen CRT-D with Gunther Prenner, During November 2009, Stryker an- On May 6, 2011, Boston Scientific an- M.D., at the Medical University in Graz, nounced the acquisition of OtisMed, a nounced the launch and first implants of Austria, “Physicians and patients will truly software company that manufactures its Energen and Punctua cardiac resyn- appreciate the longevity of these devic- custom cutting guides for total knee re- chronization therapy defibrillators (CRT-Ds) es since it may reduce the need for addi- placements. Financial terms of the deal and implantable cardioverter defibrilla- tional implant surgeries. Additionally, the were not specifically disclosed. tors (ICDs) in Europe and other interna- new therapy options, combined with the Stryker representatives believed that tional markets. The two devices are the Latitude Patient Management system, in- the OtisMed cutting guides would com- world’s smallest and thinnest high-ener- crease the variety of diagnostic parame- plement the company’s existing prod- gy devices to treat heart failure and sud- ters to help treat heart failure patients.” ucts, such as the Triathlon Knee. Cus- den cardiac death, and they offer excel- Most of the new Energen and Punctua tom guides have the benefit not only of lent longevity. devices offer the 4-SITE DF4 connector sys- improving implant fit, which can reduce “These devices build on the techno- tem option, designed to simplify the im- the risk of failure, but also have the po- logical advancements of Cognis and plant procedure and comply with interna- tential to reduce the amount of bone re- Teligen by providing options to custom- tional connector standards. Additionally, moved for the procedure. Preserving tis- ize therapy for individual patients,” says nearly all models are compatible with Bos- sue has increasingly been a focal point in Professor Joachim Winter, M.D., who per- ton Scientific’s Latitude Patient Manage-

Source: Boston Scientific

5 ment system, which enables physicians of the breast, affects more than 250,000 groups of women were selected from 18 to remotely monitor implantable cardi- American women each year. Breast can- plastic surgery practices in which the sur- ac device patients between on-site of- cer is the most common type of non-skin geons had performed large numbers of fice visits. cancer among women, and the leading cosmetic breast implant surgeries before “The Energen and Punctua devices are cause of cancer death in women, after 1989 and were willing to give the investi- designed to improve the ability of physi- lung. gators access to their records. cians to deliver effective patient care,” After a woman is diagnosed with Typically, implants are soft silicone says Hank Kucheman, executive VP and breast cancer, she faces many difficult sacs, inflated with either saline solution group president, cardiology, rhythm and and personal treatment decisions, includ- (salt water) or a synthetic silicone gel. vascular for Boston Scientific. “This new ing whether or not to undergo breast re- Both have been marketed since 1962. portfolio of products, built on our tradition construction. About one-third of wom- Before the 1992 FDA ban, 90% to 95% of of innovation, continues our advantages en who undergo mastectomy go on to the implants contained silicone gel be- in size, shape and longevity and provides have breast reconstruction. The num- cause they had a more pleasing look and multiple therapy options to match specif- ber of breast-cancer patients undergo- feel than the saline-filled implants. Since ic patient needs.” ing breast-reconstruction surgery has in- 1992, 90% to 95% of the implants have The company received CE Mark ap- creased substantially during recent years been saline-filled. proval for its Energen and Punctua CRT- due to growing consumer awareness About 80% of breast implants in the Ds and ICDs in October 2010. In the United about the procedure, and expanded ac- United States are for cosmetic reasons States, they are investigational devices, ceptance of plastic surgery among con- and 20% for breast reconstruction. Indus- limited by applicable law to investigation- sumers, especially for reconstruction. try analysts believe that 1.5 million to 2 mil- al use and not available for sale. The com- About 10 years ago, in one of the larg- lion U.S. women have had breast implants pany expects FDA approval for the devic- est studies conducted on the long-term since they first appeared on the market es in late 2011 or early 2012. health effects of silicone breast implants, in 1962. Boston Scientific is a worldwide de- researchers from the National Cancer In- During January 2011, U.S. government veloper, manufacturer and marketer of stitute (NCI) in Bethesda, Md., found no health officials announced an investiga- medical devices. The company’s prod- association between breast implants and tion into a possible link between breast ucts are used in a broad range of inter- the subsequent risk of breast cancer. The implants and a very rare form of cancer, ventional medical specialties. study is published in Cancer Causes and raising new questions about the safety of On Jan. 14, 2011, Bionx Implants Inc. Control. devices that have been scrutinized for de- received 510(k) clearance from FDA for Breast implants first appeared on the cades. its absorbable cannulated Bankart Tack. market in 1962. Manufacturers initially as- The cancer, known as anaplastic large The Bankart Tack is indicated for use in the sumed that the implants were biological- cell lymphoma, attacks lymph nodes and internal fixation of soft tissue to bone for ly inactive and, therefore, would have no skin and has been reported in the scar tis- repair of anterior shoulder instability in pa- harmful effects. However, over the past sue which grows around an implant. FDA tients with Bankart lesions. two decades there have been a number is asking doctors to report all cases of the “We are pleased that we have been of reports of connective tissue disorders cancer so that the regulatory agency can able to complete the FDA process for our and cancers among implant patients. better understand the association. Bankart Tack,” reports David Anderson, In 1992, because of the lack of suffi- FDA is aware of 60 cases of the disease president and CEO, Bionx Implants. “We cient evidence on the long-term safety worldwide among the estimated 5 million believe that the Tack complements other of implants, FDA restricted the use of sili- to 10 million women with breast implants. products in our absorbable orthopaedic cone breast implants to women seeking The regulatory agency reviewed the sci- product line and will enable surgeons in breast reconstruction in controlled clini- entific literature going back to 1997 along the United States to benefit from the appli- cal trials. Congress directed the National with information provided by international cation of the Bionx self-reinforced resorb- Institutes of Health to undertake a large governments and manufacturers. able technology for injuries to the shoul- follow-up study to evaluate the long-term Most of the cases were reported af- der. We intend to commence sales and health effects of the implants. ter patients sought medical care for marketing efforts for the Bankart Tack as The average length of follow-up was pain, lumps, swelling and other problems soon as possible.” 12.9 years among the implant patients around the surgical site. Bionx Implants is a leading developer, and 11.6 years among the comparison Breast implants come in saline and sili- manufacturer, and marketer of self-rein- patients. In previous studies, women with cone-gel filled formulations and are mar- forced, resorbable polymer implants, in- implants were generally followed for less keted in the United States by Allergan Inc. cluding screws, pins, arrows and stents, than 10 years. and Johnson & Johnson’s Mentor Corp. for use in a variety of applications. These The participants included 13,500 wom- Those companies are required to update applications include orthopedic surgery, en who had implant surgery for cosmet- the labeling for their products to reflect urology, dentistry and maxillo-facial sur- ic reasons in both breasts sometime be- the cancer cases. gery. tween 1962 and 1989 and, for comparison, A handful of researchers have pub- about 4,000 women similar in age who lished papers on instances of anaplastic Breast Implants had some other type of plastic surgery, large cell lymphoma in breast-implant pa- such as removal of fat from the stomach, tients. In the last three years, medical re- Breast cancer, which forms in the tissues or wrinkles from the face and neck. Both views of those studies have raised new 6 questions about the link and prompted devices moving within the breast and al- a foreign body like the breast implant is FDA’s review. tering the breast shapes make them un- variable. In most cases the tissues around Lymphoma is an aggressive form of popular with most plastic surgeons and the implant organize in a smooth and pli- cancer, and patients’ survival varies wide- patients.” able envelope that remains soft. In some ly between different forms of the disease. According to Dr. Diana, high-density cases, however, the scar formed around Chemotherapy is usually the first line of silicone gel implants and dual-density sil- the implant may become hard and con- treatment and patients who have com- icone gel implants are available in restrict- strict the implant and the breast into ab- plete remission have gone on to live ed studies and promise additional choic- normal shapes and change the breast long, healthy lives. Patients who relapse es in shape control. The commonly called and the implant position on the chest. are usually treated with a bone-marrow “Gummy Bear” implants are still not unre- “Capsular contracture may be painful transplant and have a much lower rate stricted in the United States. and lead to thinning of the breast tissue of survival. According to Dr. Diana, silicone-filled that is irreversible,” Dr. Diana observes. Mentor Worldwide LLC officials sup- breast implants have attracted media The implants may be visible or palpa- port FDA’s efforts to gather additional attention since the 1980s for the contro- ble in various parts of the breast, causing data and study ALCL (anaplastic large versial statements by attorneys and plain- a wave-like appearance that is described cell lymphoma) in patients with breast im- tiffs involved in the legal battles with Dow as “rippling.” In some cases, severe rip- plants. Mentor has been closely monitor- Corning, the company leader in breast pling may cause breast distortion with ex- ing case reports of patients with ALCL, a implants manufacturing at that time. Dur- ercise and lead to implant removal. rare form of non-Hodgkin’s lymphoma, ing the “Breast implant scandal,” silicone- According to Dr. Diana, FDA’s approv- since reports first appeared in the med- filled breast implants were restricted for al process for breast implants has been ical literature regarding this condition. use in the United States due to concerns slow and somewhat limiting to patient Mentor has provided and continues with safety, and were only available with- choice. “However, the legal environment to provide information to FDA and other in specific protocols and in limited num- of the last few decades, and ultimately regulatory agencies about the safety of bers for many years. the concern for patient safety, has justi- its products. Mentor officials agree with “During that time, a now famous class fied a careful and calculated approach FDA’s assessment that, “because the risk action law suit resulted in significant finan- in this matter,” he says. of ALCL appears very small, FDA believes cial losses to the manufacturing compa- Since breast augmentation is a fee-for- that the totality of evidence continues to nies even though there was little or no sci- service procedure, the economic slow- support a reasonable assurance that FDA- entific evidence of connection between down has affected the number of proce- approved breast implants are safe and the implants and the alleged damag- dures performed. “Overall, the cosmetic effective when used as labeled.” es sustained by the plaintiffs,” Dr. Diana surgery industry sees a decrease in vol- According to Mario Diana, M.D., FACS, shares. ume due to consumer financial con- managing director of New Day Plastic Silicone-filled breast implants again at- cerns,” Dr. Diana observes. Surgery, Allergan’s acquisition of Inamed tracted the media spotlight in 2006 when Some sources indicate, however, Corp. was particularly interesting. “The ac- FDA cleared them as safe and effective that during periods of relative economic quisition made the Botox and filler domi- for breast augmentation after extensive downturn cosmetic procedures actually nant market leader also a major player in research and investigations failed to dem- increase in frequency due to the consum- the breast implant market,” he says. onstrate any linkage between the im- er desire for gratification. Through the deal, Allergan acquired plants and the autoimmune diseases or The development of new implant ma- the breast implant and LAP-BAND maker conditions that were the subject of the le- terials has attracted the spotlight, such as Inamed (formerly McGhan). The compa- gal battles in the 1980s, Dr. Diana says. shell-free implants, high-density silicones, ny offers the full range of cosmetic breast “Breast implants risks are widely doc- dual and triple lumen implants, dual-den- implants including new and improved umented in industry and medical publi- sity silicone, antibiotic impregnated shells high-density silicone gel and new shapes/ cations and include some implant spe- and biological implants. All of these are sizes for increased patient choice. cific and other risks that are associated areas of active research and should pro- Despite the unrestricted availability of with the implant surgery itself,” Dr. Diana duce a dramatic change in the breast- silicone filled breast implants since 2006, explains. implant product landscape in the next saline filled breast implants remain best- The specific risks of breast implants few years, according to Dr. Diana. selling products. “This is mostly due to the are rupture, capsular contracture and In the population of women with breast concerns about safety of the silicone in rippling. cancer, those who have previously under- the event of implant rupture,” Dr. Diana The implant shell may over time lose gone surgery to receive breast implants shares. Mentor Corp. and Allergan have its integrity and lead to the filler material face no poorer prognosis than do those been the industry leaders in the United to be released in the body. Rupture rates without implants, despite the fact that States. have been described ranging from 1% mammograms were less accurate at “Smooth, round implants are the most to 6% by various manufacturers and are picking up abnormalities in this group of commonly used implants, despite the devices specific to some extent. “Implant women. These findings were announced availability of textured devices and oth- rupture requires implant replacement in as part of a small study in April 2011, lead er devices with various shapes resembling short order and therefore additional sur- by Dr. Jessica A. Rayhanabad, a fellow in the normal breast anatomy,” Dr. Diana gical expenses,” Dr. Diana says. the breast surgery division at USC’s Keck explains. “The recurrent issues with shaped The body response to the presence of School of Medicine in Los Angeles. 7 Although women who had breast im- vided to breast-cancer patients, and as is a highly porous metal engineered to al- plants were more likely to have tumors part of their continuing commitment to low bone integration, which can enhance that could be detected by touch alone patient education, the CSC launched fixation. Regenerex material is used for the and were also more likely to have breast Frankly Speaking about Cancer: Spotlight hip cup, the implant that resurfaces the cancer that had spread to the lymph on Breast Reconstruction. This thoughtful damaged socket portion of the hip. The nodes, the researchers determined that and comprehensive patient empower- cup can then be used with E-Poly Vita- the survival rates among both groups in ment program streamlines information min E liners. the study were similar. about breast reconstruction, emphasiz- Polyethylene is a form of plastic that For the study, the researchers reviewed ing up-front education and tools for de- is commonly used in joint replacement the records of 5,005 women who had cision making. The national program en- implants. Individual implants can be ma- been treated for breast cancer during the courages women to speak openly with chined from a single larger piece or they past 15 years to determine whether the their physicians about whether recon- can be manufactured one piece at a patients with breast implants were diag- struction is right for them. time. Polyethylene is one of several pre- nosed with more advanced disease and Developed with support from Men- ferred materials for joint replacement be- therefore had a poorer prognosis. In the tor Worldwide, the program leverag- cause it is strong and is generally accept- study, a total of 195 women had previous- es the survey findings as well as medi- ed by the body after implantation. ly undergone breast augmentation, and cal and community partner expertise to Polyethylene has several characteris- 121 had a mammogram before their di- bring comprehensive literature, in-person tics that make the material ideal to use for agnosis. The test failed to reveal an ex- workshops, and online resources to breast joint replacement. The material is smooth, isting abnormality in 36% of these cases, cancer patients during their first stages of which is good for metal implants to move compared with a false-negative rate of treatment. against. Polyethylene can additionally 15% in the general population. help absorb some of the impact of ev- However, the researchers found no dif- Implant Materials eryday activities like walking, biking, shop- ference in tumor size, recurrence rate or ping, and golfing. Although polyethylene survival rates between the two groups. Implant fixation to the bone is one of the is a strong material for joint replacement, The study was somewhat limited and factors that should be closely consid- some manufacturers use different meth- therefore, the results are considered pre- ered in joint replacement surgery. Some ods to further decrease the wear of the liminary. implants require bone cement to secure, material. On Sept. 29, 2010, a survey of 762 wom- or fix, the implant in place. Bone cement Antioxidants are not only good for the en with breast cancer who were eligible has been used since the earliest proce- human body, but for polyethylene joint re- for breast reconstruction conducted by dures were done and is still currently used. placement implants too. Polyethylene in- the Cancer Support Community (CSC) Usually bone cement is used in patients serts can react with oxygen, creating an found that 43% of patients do not receive with poor bone quality to help stabilize effect similar to a browning apple. This re- information about breast-reconstruction the knee components. action is known as oxidation, which over options when making treatment deci- Other implants are manufactured with time can weaken the polyethylene inserts. sions at diagnosis. Findings also suggest special coatings and rough surfaces that Biomet’s E1 inserts are produced with Vita- that a credible, accessible and validated help natural bone grow onto it to achieve min E, a natural antioxidant that in labora- single resource for patients on the topic fixation. An implant with a porous surface tory testing has been shown to protect the of breast reconstruction is not available. or tiny beads, and good quality bone are material from the effects of oxidation. Bi- This demonstrates the need for a compre- required for cementless fixation. Often- omet is currently the only company offer- hensive information source about breast times, a combination of cement and ce- ing antioxidant technology in hip or knee reconstruction to help patients make an mentless knee components are used. implants in the United States. informed, educated and personally sat- Biomet continues to work on introduc- Because hip implants can wear over isfying decision. ing new technologies that may increase time, Biomet developed an implant de- “Despite improved access to infor- the longevity of its orthopedic implants. signed to address the higher demands of mation about breast reconstruction, our Two technologies have been introduced more active lifestyles. Traditionally, hip-re- survey found that there remains a need recently with implants available for total placement implants feature a metal ball for an all-inclusive patient education re- hip replacement. that moves against a polyethylene cup. source that enables women to think about E1 Antioxidant Infused Technolo- Metal-on-metal hip replacements feature what’s personally important to them so gy from Biomet is the only Vitamin E en- a metal ball that moves against a metal they can be empowered to ask the right hanced polyethylene. The process begins cup. This metal cup is what provides the questions and make the best decision,” with Biomet’s clinically proven ArCom additional resistance to wear. says Kim Thiboldeaux, president and CEO polyethylene. Vitamin E, a natural an- Metal-on-metal components have of the CSC. “Educating women about all ti-oxidant, is then added to the ArCom been used and studied in orthopedics their options at diagnosis when it matters poly, which has demonstrated in labora- for more than 35 years. When polyethyl- most is the best way to reduce decisional tory testing a greater resistance to harmful ene components were introduced, most regret, no matter what they decide to do oxidation. Polyethylene oxidation is similar manufacturers moved away from all-met- with regard to breast reconstruction.” to rust on a car, which can weaken the al components. However, newer manu- To address the challenge of overcom- polyethylene. facturing technologies and the desire to plicated or insufficient information pro- Regenerex Porous Titanium Construct improve wear capabilities have created 8 renewed interest in metal-on-metal com- icized metal hip implants in the global or- Spinal fusion procedures are common ponents. thopedic market. VERILAST technology is orthopedic procedures used to treat dis- Research has demonstrated several used in both hip and knee replacement orders of the spine including degenera- advantages of metal-on-metal compo- implants. tive conditions, deformities, spinal trauma nents. In laboratory testing, all-metal com- and tumors. In 2009, more than 500,000 ponents demonstrated a 99% reduction in Spinal Implants spinal fusion procedures were performed wear compared with conventional poly- in the United States, a figure growing by ethylene components. DiFusion Technologies Inc. is a medical- more than 4% annually. One of the im- Biomet’s M2a-Magnum Metal-on-Met- device company focused on the de- plants often used in these procedures is al Hip has a wide range of size options. velopment and commercialization of the interbody fusion device, a market ap- The size options allow surgeons to choose its proprietary CleanFUZE anti-microbial proaching $1 billion. The Xiphos line of in- the largest possible implant for each pa- technology for orthopedic implants. On terbody devices is DiFusion’s entry into this tient. Large heads (ball portion of implant) Oct. 6, 2010, the Austin, Texas-based com- segment. potentially provide greater resistance to pany announced the 510(k) clearance of Though most interbody fusion cages dislocation and improved implant stabili- its new Xiphos line of posterior interbody are made of titanium, a new material is ty. Biomet’s M2a-Magnum metal-on-met- devices indicated for intervertebral body quickly gaining popularity with surgeons. al hip system has been carefully designed fusion of the lumbar spine, from L2 to SI, in Polyether-etherketone (PEEK) is a hard ra- to provide maximum range of motion, of- skeletally mature patients who have had diolucent plastic that is used in conjunc- fering the potential for more than 160 de- six months of non-operative treatment. tion with carbon fiber reinforcement or as grees range of motion. The M2a-Magnum The device is intended for use at either pure PEEK. Most manufacturers who use hip’s large range of sizes allows for bet- one level or two contiguous levels for the PEEK use radio-marker dots so the surgeon ter replication of a patient’s anatomy. treatment of degenerative disc disease can see where the implant meets the ver- Only metal-on-metal components allow (DDD) with up to Grade I spondylolisthe- tebral body endplate. Zimmer Spine, Sur- the largest heads throughout the entire sis. The Xiphos System of implants is also gicraft, SCIENT’X, and DePuy Spine Inc. range of implant sizes. indicated for use to replace a vertebral have developed lines of interbody fusion On Dec. 2, 2010, a newly released pa- body that has been resected or excised devices using PEEK technology. tient registry reported that hip-replace- (i.e. partial or total vertebrectomy) due to FDA cleared a PEEK interbody hollow ment implants made from ceramicized tumor or trauma/fracture. The system is in- implant that allows bone to grow through metal heads that articulate against poly- tended for the thoracolumbar spine (from the device and fuse adjacent bony sur- ethylene lined cups have been shown to T1 to L5) and for use with supplemental in- faces to the vertebrae. The Xiphos posteri- have superior survivorship compared with ternal fixation. or interbody device manufactured by Di- implants made from any other material “This clearance marks a milestone in Di- Fusion Technologies is made with Zeniva five years after surgery. Fusion’s commercial pathway,” says John PEEK, which has been shown to be stron- OXINIUM Oxidized Zirconium and Kaelblein, president of DiFusion. “Not only ger than comparable materials based cross-linked polyethylene (XLPE), the ma- does it provide us an early stage revenue on biomechanical testing. The testing terials in VERILAST technology from Smith source, the Xiphos line is also a platform also revealed that the material shows no & Nephew’s Orthopaedics Division, com- on which we will continue to develop our evidence of cytotoxicity, sensitization, ir- prise the overwhelming majority of ceram- CleanFUZE line of fusion devices.” ritation, or acute systemic toxicity. Zeniva PEEK is part of Solvay Advanced Poly- Smith & Nephew mers LLC’s line of Solviva biomaterials, materials that have a modulus that is close to bone. According to Solvay, there are more than 10 devices that use this material and have been cleared by FDA. “The Xiphos posterior interbody platform includes an array of implant shapes and sizes for varying patient anatomy and surgical preference allowing for posterior, posterior oblique and transforaminal approaches,” remarks Dr. Jami Hafiz, Ph.D., VP of development for DiFusion Technol- ogies. “We really focused on developing a best in class series of implants that could serve as a platform for future development.” Founded in 2008, DiFusion Technologies is a medical-device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine sur- Source: Smith & Nephew gery through the development of a suite 9 of patented antimicrobial orthobiologic The SpineShield received CE Mark in come infected and that will cause health polymeric implants. Initially focusing on November 2009, and is available for mar- issues, however, removing the leads can the multi-billion dollar spinal implant marketing in select world markets. The prod- be difficult and adds to the time in sur- ket, the company has developed a tech- uct is awaiting 510(k) clearance and is gery. nology with applicability across a variety not available for sale within the United “We see an opportunity here for Spec- of orthopedic segments using well-char- States. tranetics,” Dr. Corner says. Spectranetics acterized implants with benefits for the Magen was expected to launch the Corp. has a device to aid the surgeon in patient, surgeon, hospital and payer. SpineShield in select European Union mar- removing the leads. The company is doing CleanFUZE orthobiologic polymers kets in 2010. The company is also devel- a post-approval registry trial to look at out- have not been approved by FDA. Clean- oping further product lines based on the comes for patients who have old leads re- FUZE is not available for sale within the same technology for tendon and nerve moved, compared to those whose leads United States. applications. are left inside. On April 19, 2010, Magen Medical So- “We think that implantable devices, lutions Ltd. successfully implanted its first Biologically based Implants like all devices, now have to demonstrate product, the SpineShield, in three pa- that they provide better outcomes and tients at a clinical site in Europe. Magen With medical implants, the risks are infec- significant cost saving to drive adoption,” is a medical-device company develop- tion – as with most surgical procedures – Dr. Corner explains. “It is no longer enough ing unique anti-adhesion devices for or- and rejection. For the companies work- just to prove something works or is as good thopedic applications ing on biologically based implants (such as a predicate device; devices must re- Post-operative adhesion is considered as Tengion Inc. and Cytori Therapeutics duce hospital stay lengths, have better a major cause of failed back surgery. In Inc.), the thought is that by using biologi- outcomes, or reduce costs as compared nearly 15% of cases, patients suffer from cally based materials or autologous cells, to existing approved products.” pain due to spinal adhesion, or scar-tis- rejection will be minimized. Peripheral stents will be competing with sue formation around the spinal cord, Cytori has gained regulatory approv- an increasing number of devices focused which may require a second surgery for al in the European Union and is seeking on removing plaque from vessels in com- correction. Magen’s flagship device, the approval in the United States for stem- ing years, according to Dr. Corner. “We SpineShield, uses the company’s propri- cell enriched adipose tissue implants. expect to see new offerings in the de- etary technology to prevent fibrotic ad- The company’s first indication is for post- vice space, such as the laser-based de- hesion of the scar to the dura and the lumpectomy reconstruction, an area with bulking technologies from Spectranetics nerve root and to reduce related pain a clear unmet clinical need. which could reduce the need for stents and complication risks. The SpineShield is “Currently lumpectomy patient with in the vessels of the upper leg,” Dr. Cor- a metal device that physically separates malformed breasts are limited to wear- ner says. the scar from the delicate spine structures. ing prosthetics or undergoing mastecto- Analysts with McNicoll, Lewis & Vlak ex- After healing, the SpineShield is removed my and getting a complete reconstruc- pect a move toward products with a bio- during a short minimal invasive outpatient tive procedure,” Dr. Corner explains. “We logical component to encourage incor- procedure. think there is a large opportunity in the poration and discourage rejection of the Magen initiated its first-in-human, sin- aesthetic surgery market for Cytori’s tech- implants. In the spine area, Medtronic’s gle-center, prospective feasibility study nology.” INFUSE product was the first blockbust- to assess the initial safety and efficacy of Dr. Corner believes that Tengion has er that combined demineralized bone the SpineShield implantation for the pre- some interesting products in develop- matrix combined with a growth factor to vention of epidural scar fibrosis following ment to support and replace organs and generate better spinal fusion. Other com- hemilaminectomy. The study is being held tissues. The company is using a patient’s panies such as BioMimetic Therapeutics in the Neurosurgery Department of the cells to build new bladders (in Phase II clin- inc. and Stryker have been working to de- Bagdasar Arseni Emergency Hospital ical trials) and have development proj- sign similar offerings in bone reconstruc- located in Bucharest, Romania. ects focused on the vascular and gastro- tion in recent years with various degrees Three SpineShield devices have been intestinal areas. of success. successfully implanted and removed “Although the patient populations of The analysts have also seen success from three patients. The removal proce- some of these applications are fairly small, from LifeCell Corp. (a Kinetic Concepts dure was performed through a minimal we are very excited about the prospects Inc. company) during the last 10 years. invasive 1cm incision. According to ini- that regenerative medicine technolo- KCI uses cadaver tissue to reconstruct, tial feedback from patients and physi- gies can bring to the surgical arena,” she among other things, abdominal walls. The cians, the removal procedure was pain- says. company has seen less rejection and less less, easy, and took only a few minutes. encapsulation during abdominal wall re- No complications were reported. An ad- Pacemakers and Defibrillators constructions when compared to stan- ditional seven patients will be enrolled in dard mesh supports. the study. Recently there has been a debate about “A lot of KCI’s abdominal wall surgeries Researchers working on the clinical whether surgeons should remove old pac- are performed on obese patients, and we study expect the SpineShield to dramat- ing and defibrillation leads when replac- think the number of these surgeries (usu- ically reduce fibrosis adhesion observed ing or removing those devices. The risk for ally hernias) will continue to increase in in post-operative MRI images. the patient is that leads left inside will becoming years,” Dr. Corner says. 10 Hip and Knee Implants son recall of hip implants used on 93,000 and knee replacement surgeries that take patients. place in the United States annually and, In knee replacement surgery, the knee it- One of registries was organized by the over time, record which implants failed self is not replaced, only the damaged orthopedic industry and the other was prematurely, requiring revision surgery to cartilage and bone ends. Knee-replace- funded by the federal government. Ac- fix the original operation. ment implants include a metal alloy on the cording to the doctors involved, the da- The organizers intend to collect basic end of the thighbone and polyethylene tabases are designed to replicate and im- information and plot survivorship curves on the top of the tibia and underneath prove on national databases in countries for implants, so they know when they go in the kneecap. The implant is designed to including Australia and Sweden. and when they come out. Monitoring the create a new, smoothly functioning joint DePuy Orthopaedics, a unit of J&J, is- successes and failures of these implants that can prevent painful bone-on-bone sued a voluntary global recall of its ASR will ultimately save money for insurers. contact. device in August after learning of height- DePuy announced the ASR recall on Hip-replacement surgery removes the ened failure rates from data collected by Aug. 26, 2010 after 93,000 of the devic- arthritic ball of the upper femur as well the United Kingdom’s national joint regis- es had been had been implanted in pa- as the damaged bone and cartilage try. The company faces more than 1,000 tients worldwide, including 37,000 in the from the hip socket. The damaged bone lawsuits in state and federal courts by pa- United States. The company cited unpub- and cartilage are replaced with implants tients who had the hip implants. lished 2010 data from the United Kingdom made from materials including metal al- The leading hip makers behind J&J are showing that within five years, 13% of its loys, polyethylene, or ceramic. Zimmer Holdings and Stryker. The world- ASR XL Acetabular hips failed and need- When the hip, a “ball and socket” joint, wide hip replacement market is expected ed to be replaced. gets damaged it can produce severe to grow more than 3% during 2011 from DePuy also makes spinal-care devic- pain and limit movement. Hip-replace- $5.28 billion in 2010. U.S. hip and knee im- es and generated $5.59 billion in revenue ment surgery involves removing and re- plants account for more than half of all in 2010. DePuy representatives have said placing the diseased joint with an artifi- joint replacement procedures globally. the company withdrew the hips for safe- cial one designed to recreate the natural The American Joint Replacement ty reasons, while denying in court papers ball and socket joint of the hip. Successful Registry (AJRR), which is funded by or- that the devices are defective. hip-replacement surgery can relieve pain thopedists, prosthetic manufacturers, in- J&J had committed $280 million to and restore movement. surance companies and hospitals, began the recalls as of March 31, 2011, and has The implants are designed to create a collecting data from 16 hospitals in De- pledged to “address reasonable and cus- new, smoothly functioning joint that can cember 2010 as part of a pilot program tomary costs associated with testing and replace the painful bone-on-bone con- according to its chairman, David Lewal- treatment,” including new hips for pa- tact. len, a professor of orthopedic surgery at tients who need them. Due to a recent wave of product re- the Mayo Clinic in Rochester, Minn. The A second registry, funded with a $12 calls, two doctors’ groups created data- group plans to roll out the data collection million grant from the Agency for Health bases to track the success rates of artifi- system nationwide during 2011. Care Research and Quality, a division cial hips and knees in the United States. According to Mr. Lewallen, the goal is of the U.S. Department of Health Care This occurred following a Johnson & John- to track the more than 700,000 total hip and Human Services, is being run by the University of Massachusetts Medical Zimmer Holdings School, according to the registry Web- site. The UMass registry tracks the experi- ences of more than 30,000 patients who undergo hip or knee implants each year, said Patricia Franklin, professor of orthopedics at the university and the principal investigator behind the study. The registry is also designed to track patient experience in the hopes of learning why some implants succeed and others fail. This registry is intended to comple- ment the national registries. As such, the researchers will be looking for information beyond the success of the implant. They will be tracking the patient’s personal experience including pain levels. FDA asked Johnson & Johnson, Zim- mer Holdings and 19 other medical-device makers for data on metal levels in Source: Zimmer Holdings the blood of patients implanted with metal-on-metal hip implants. The regulatory 11 agency sent letters on May 6, 2011, to J&J Conditions for approval recommended dics acquired the Leatherhead, United and other hip-implant makers including by the panel include refinements to the Kingdom-based hip implant maker Fins- Biomet, Stryker and Zimmer Holdings ask- proposed product labeling and a post- bury Orthopaedics Ltd. for an undisclosed ing them to perform post-market studies approval study. amount. The deal required Finsbury to pro- of their hip replacements. The Pinnacle CoMplete System is an vide DePuy with several product lines, in- FDA officials are reportedly aware of investigational device limited by U.S. law cluding ceramic and metal hip systems, a the public-health questions regarding to investigational use only. A DePuy ce- total ankle replacement and several small the safety of metal-on-metal total hip- ramic-on-metal bearing has been mar- joint reconstructive implant lines. Founded replacement systems. The device com- keted in 40 countries outside the United in 1978, Finsbury reported about $55 mil- panies are currently seeking further clari- States since 2007. lion in annual sales each year. fication from the regulatory agency and According to the American Acade- considering how to best meet its require- my of Orthopaedic Surgeons (AAOS), Dental Implants ments. about 33 million Americans are affect- DePuy Orthopaedics’s Pinnacle CoM- ed by osteoarthritis, a degenerative joint The dental implant market is character- plete Acetabular Hip System gained ap- disease. More than 193,000 total hip re- ized as a large under-penetrated piece proval Aug. 18, 2009 as the first ceramic- placements (THR) are performed each of the global dental industry. The United on-metal implant to be sold in the United year in the United States, mostly due to States, Europe and Japan dominate the States. Although FDA’s review of the prod- some form of degenerative arthritis. dental market with more than 80% of the uct prior to approval found that the device DePuy Orthopaedics has a wide range global revenue. An increasing aging pop- didn’t substantially reduce the accumula- of implants for hip replacement made ulation coupled with rising awareness for tion of metal ions in the body, the agency from other combinations of materials in- oral health, high esthetics and improved issued a generally positive review. cluding metal-on-metal, ceramic-on-ce- dental treatments in recent years have FDA’s Orthopaedic and Rehabilita- ramic, metal-on-polyethylene and ce- boosted the growth of this segment. Ex- tion Devices Advisory Committee issued ramic-on-polyethylene. This is the first perts predict that the market will sustain a recommendation based in part on re- time ceramic and metal-bearing surfac- double-digit growth due to a worldwide sults from a two-year controlled, random- es are being combined in a hip replace- rise in the toothless population. ized, blinded, prospective, multicenter, ment system in the United States. During the last few years, the implant in- non-inferiority clinical study and labora- DePuy Orthopaedics is a leading glob- dustry has transitioned from the use of con- tory testing that compared the safety and al provider of orthopedic devices for hip, ventional materials (onlays, inlays, crowns, effectiveness of the Pinnacle CoMplete knee, extremities and trauma, as well as bridges, and partial or full dentures) to all- System to a commonly used DePuy met- bone cement and operating-room prod- ceramic, individualized products based on al-on-metal implant. ucts. The company is part of the DePuy CAD/CAM techniques. Additionally, the The clinical study showed no signifi- Family of Companies, which have a rich market has witnessed an increased de- cant difference in adverse events, revi- heritage of pioneering a broad range of mand for fast and minimally invasive pro- sion rates and survivorship after two years, products and solutions across the con- cedures, good esthetics and long-lasting re- and patients experienced similar pain re- tinuum of orthopaedic and neurological sults. As a result, companies have begun to lief, improved function and range of mo- care. increase their investments in R&D and in the tion. Laboratory testing on the Pinnacle In December 2009, DePuy Orthopae- launch of new and innovative products. CoMplete System showed a greater than 90% reduction in wear compared to the Zimmer Holdings metal-on-metal system under normal gait conditions and a more than 80% reduction in wear under adverse conditions. “We are pleased with the panel’s recommendation, and if approved by the FDA, the Pinnacle CoMplete System would represent an important innovation for hip replacement in the United States,” reports Pamela Plouhar, Ph.D., VP, worldwide clinical affairs, DePuy Orthopaedics. “Each new implant provides orthopaedic surgeons and their patients more choices, which result in more individualized treatment based on specific patient anatomy, lifestyle, age, medical condition and surgeon preference.” The Pinnacle CoMplete System was designed to be used in adult patients who suffer from severe pain and disability due Source: Zimmer Holdings to osteoarthritis or post-traumatic arthritis. 12 Analysts believe that the Asia-Pacif- use for any orthopedic device that is to- cia Crosse, Ph.D., director of the health ic and Latin American region has enor- day made of either commercial purity ti- care team at the Government Account- mous growth potential due to large pop- tanium or titanium alloys. “Since virtually ability Office (GAO). Dr. Crosse’s testimo- ulations, rising per capita incomes and a every metal and alloy can be nanostruc- ny outlined the preliminary findings of a growing middle class. In Europe, coun- tured, one can expect that within 10 years continuing GAO investigation into FDA’s tries such as Italy, Sweden and Switzerland virtually every class of metallic implants will management of the medical-device re- have a higher dental-implant penetration benefits of nanostructuring,” he says. view, post-market monitoring and recall rate when compared to the more ma- processes. ture and developed markets of the Unit- Stents In her testimony, Dr. Crosse indicated ed Kingdom and France. that concerns persist about the effective- According to some analysts, the glob- OrbusNeich Medical Inc. officials an- ness of the 510(k) process in general, in- al leaders in the dental implant industry in- nounced positive results from a Genous cluding its ability to provide adequate clude Nobel Biocare Services AG, Strau- stent implantation on Aug. 23, 2010. A pa- assurance that devices are safe and ef- mann and Dentsply Inc. The five major tient implanted with OrbusNeich’s Genous fective. She attests to gaps in FDA’s post- dental implant manufacturers account Bio-engineered R stents showed 100% strut market surveillance process that allow the for nearly two-thirds of the total worldwide and complete neotintimal coverage 26 continued use of unsafe and ineffective market. A recent increase in regional im- days after the procedure, according to devices, despite recalls. plant manufacturing companies, how- company reports. Getting new technologies to market ever, has resulted in intense competition The patient, a 62-year-old male, re- should not be done at the risk of patient and consolidation in the global dental in- ceived two 2.5-mm diameter models of safety. Senator Kohl contends that faulty dustry. the stents after doctors diagnosed an an- medical devices, especially those im- Terry C. Lowe, Ph.D., chief scientist of terior ST-elevation myocardial infarction. planted in the body, can have a disas- Manhattan Scientifics Inc., believes that Johnson & Johnson subsidiary Cordis trous impact on the health of those who the Biotanium dental implant from BA- Corp. in August 2010 was touting the 10- use them. SIC Dental Inc. is positioned to eclipse the year anniversary of the first implantation Procedural and management chang- dental-implant market with the introduc- of its Cypher drug-eluting stent. Cordis es have been implemented at the Cen- tion a new material: nanostructured com- gained FDA approval for its 2.25-mm ter for Devices and Radiological Health mercial purity titanium. Because of the Cypher drug-eluting stent for treating in recent months due to internal reviews nanoscale features of the metal, the Bi- blockages in small blood vessels. by FDA officials that have revealed lapses otanium implant provides greater strength Cordis conducted four studies com- in the procedures by which a number of and biocompatibility than all dental im- paring the 2.25-mm Cypher sirolimus-elut- medical devices were approved. plants made of conventional titanium. ing coronary stent with bare-metal stents. The medical-device industry is con- “Nanostructured metals and alloys are Cordis representatives have claimed its cerned that these management prob- being aggressively developed for use in product is superior compared with Bos- lems have slowed medical-device inno- implants,” Dr. Lowe shares. The nanoscale ton Scientific’sTaxus . vation. features of these metals enhance their Cordis shared data from several clin- Although FDA has established numer- strength by 30% to 200% while also en- ical trials comparing 2.25-mm Cypher ous initiatives for more effective medical- abling bone-cell attachment to the nano- with Boston Scientific’s Taxus Liberté device approvals and post-market surveil- structured metal surface up to 20 times Atom and Taxus Express Atom stents, lance, the industry still has concerns. GAO faster than for traditional metals. which gained FDA approval for treating gave FDA a “high risk” designation in 2009 Manhattan Scientifics has licensed the small vessels. Citing the ISAR-SMART 3 trial, for its management of medical devices. nanostructured metals technology from Cordis representatives say patients treat- A recent study, led by Diana Zuck- Los Alamos National Laboratory LLC ed with its device showed 55% less re- erman, Ph.D. and published in the Ar- and is aggressively pursuing nanometal narrowing of the vessel as its walls grow chives of Internal Medicine, found that implant development, manufacturing, around the stent after eight months than the 113 highest-risk device recalls involved and marketing. patients receiving the Taxus. 112.6 million recalled products from 2005 “Using nanostructured metals can re- Patients treated with the small Cypher through 2009. duce the costs to fabricate implants,” model showed a 65% lower incidence of Senator Kohl plans to advocate for fur- Dr. Lowe observes. “Machining, forging, death or heart attack than patients treat- ther reforms at FDA and urges Dr. William coating, and bonding can be done fast- ed with the 2.25-mm Boston Scientific de- H. Maisel, chief scientist at FDA’s Center er and at lower cost.” vice. for Devices and Radiological Health, to Nanostructured titanium has become move forward with efforts to classify high- the first nanometal to enter the implant 501k Process risk devices now defaulting through the market. The first FDA-approved nanostruc- agency’s fast-track approval system. tured titanium implant is the BASIC Dental On April 13, 2011, U.S. Senator Herb Kohl, In the wake of the Johnson & Johnson Biotanium dental implant. chairman of the special committee on hip implant recall, Senator Kohl aims to Dr. Lowe believes that due to the signif- aging, held a hearing to examine FDA’s protect patient safety and correctly clas- icant advantages of nanotitanium com- role in protecting patient safety as part sify these devices. Senator Kohl has sug- pared with conventional metals, use of of the medical-device approval process. gested that FDA develop a “more robust nanostructured titanium will expand into The panel featured testimony from Mar- post-market surveillance program.” 13 TMJ Implants clinical and clinical-testing requirements, AMD, geographic atrophy and retinitis or other regulatory actions are necessary pigmentosa). On Feb. 7, 2011, FDA ordered three man- for these devices. Vitrasert was the first implant to go into ufacturers of temporomandibular joint the back of the eye and has been highly (TMJ) implants to conduct postmarket sur- Ophthalmic Implants effective in people who have poor treat- veillance studies to determine the length ment options. of time before the implants are removed Ocular medications have traditional- “When first approved in mid 1990’s, Vi- or replaced due to pain or other rea- ly been delivered through eye drops, in- trasert got some attention and was com- sons. travitreal injections and systemic means, pared to the Wright Brothers in an editorial The TMJ connects the mandible to the however, various implants are now being piece in the Archives of Ophthalmology,” temporal bone in the skull. A person may developed to deliver drugs for numerous says Paul Ashton, Ph.D., president and have an implant to replace the socket in indications. Drug-eluting devices are be- CEO of pSivida Corp, a top provider of the temporal bone or the rounded edge ing targeted as a solution to patient non- miniaturized, sustained-release drug-deliv- of the lower jaw that glides in the tem- compliance with dosing protocols. Pa- ery products. “So it’s proved a great idea poral bone socket because of an injury, tients do not want to put drops in their that has taken a long while before be- arthritis, physical abnormality, or lost mo- eyes on a regular basis. coming useful to many people.” bility. FDA has approved two drug-deliv- According to Dr. Ashton, the develop- The three manufacturers – TMJ Solu- ery devices for retina/vitreous disorders: ment of a bioerodible and the addition of tions, TMJ Medical, and Biomet Micro- Bausch & Lomb Inc.’s Retisert for non- a long-term device in the optical space fixation – make all of the currently ap- infectious posterior uveitis and Allergan’s would get a lot of attention, particularly if proved TMJ devices marketed in the Ozurdex for macular edema following the device could deliver antibodies. United States. The companies were given central and branch retinal vein occlu- In the eye space, the main risk of in- 30 days to submit a study plan to be ap- sion. fection is following drug injection. “As proved by the regulatory agency before Implants undergoing development some drugs are injected very often (ev- any postmarket studies could begin. for the treatment of glaucoma include ery month or so) the risk from an implant TMJ implants also can be used to treat a punctal plug that delivers latanoprost should be less than standard of care,” Dr. temporomandibular disorder (TMD) that from a drug-eluting core and a drug-elut- Ashton explains. “With respect to choice has not responded to more conservative ing hydrogel contact lens. of materials, the eye is very sensitive, par- treatments. These include limiting jaw Anterior surface implants in develop- ticularly to anything that can cause in- movement, soft diet, jaw splint or adjust- ment include soft contact lenses, IOLs and flammation so one has to bear that in ments, medicine to reduce pain, or phys- a device attached to the haptics of an mind.” ical therapy. IOL. To date, FDA has not approved drug- FDA generally reviews drug-delivery FDA analyzed TMJ implant-related ad- eluting contact lenses or IOLs. devices as drugs. “This process requires verse event reports submitted between Bausch & Lomb’s Vitrasert, introduced two adequate and well-controlled stud- April 30, 2004, and Aug. 17, 2010. The anal- in the early 1990s and used infrequently, ies demonstrating safety and efficacy,” ysis described a substantial number of pa- is an implantable sustained-release reser- Dr. Ashton says. “If I were a patient receiv- tients who had implants replaced within voir that contains ganciclovir for the treating one of these devices, I’d want that three years or less after implantation be- ment of AIDS-related cytomegalovirus re- too!” cause of extreme pain. This is consider- tinitis. Allergan and Bausch & Lomb have Dr. Ashton believes that drug-delivery ably shorter than the expected minimum initiated clinical trials for additional indi- implants may be a way to reduce costs, five-year life span of the device, based on cations, such as uveitis for Ozurdex, and almost regardless of how much they cost premarket mechanical testing. macular edema secondary to diabetic to make. Genentech Inc.’s Lucentis is an FDA has not recommended any retinopathy for Ozurdex and Retisert. anti-body fragment that for optimal effi- changes on use of the implants. The reg- Industry analysts indicate that im- cacy must be injected into the eye every ulatory agency may revise its recommen- plants are being developed to be used four weeks and the drug cost per injec- dations or issue other recommendations as a combination therapy for treatment tion is about $2,000. “A long-term implant after reviewing additional clinical data of neovascular age-related macular de- could be highly cost effective,” he says. from the studies. Patients who have or are generation. The biggest areas for growth in this considering a TMJ implant should consult Meanwhile, several other manufactur- sector will be in the treatment of glauco- with their health-care professional. ers are developing drug-delivery devices ma and macular degenerations includ- TMJ implant manufacturers were re- and systems, including Alimera Sciences ing age-related macular degeneration quired to collect postmarket data on their Inc. (Iluvien, fluocinolone acetonide);L ux and diabetic eye disease. In fact, Dr. Ash- implants as part of the approval process. Biosciences Inc. (LX212/voclosporin); Al- ton believes that the industry is very close However, the data collected did not ad- lergan (using the same platform as Ozur- to seeing the introduction of an effective equately address the timing or reasons for dex, but containing brimonidine tartrate treatment for macular degeneration that replacement, and the studies lost contact for the treatment of geographic atrophy does not require monthly injections. over the years with many of the enrolled due to AMD); and Neurotech Pharma- In glaucoma treatment and disease patient. ceuticals Inc. (encapsulated cell technol- management, an effective and safe As part of its review, FDA will consider ogy employing ciliary neurotrophic fac- drug-eluting device would significantly al- whether labeling changes, additional pre- tor, which may have applications in dry ter treatment management. There is no 14 drug-eluting device yet on the U.S. mar- ery systems for the eye is leading to the tory approval for the Visian Toric ICL in the ket for glaucoma treatment. development of more customized materi- United States and Japan,” Mr. Caldwell A major issue in glaucoma treatment als, and particularly the use of nanotech- stated. “The market in Japan offers a very continues to be patient compliance re- nology to try to deliver antibodies. large opportunity for the ICL technology, garding daily eye drops. Researchers are On Jan. 4, 2011, STAAR Surgical Co. particularly given the high percentage of currently looking at various methods to – a leading developer, manufacturer the population who experience myopia deliver glaucoma drugs to the eye includ- and marketer of minimally invasive oph- and astigmatism. With the Japan market ing drug-eluting ocular conformers with thalmic products – announced that the for the ICL available the entire year, we antifibrotic agents, medicines placed in a worldwide total number of Visian ICL im- expect our growth rates in 2011 to exceed glaucoma shunt, contact lenses, punctal plants in patients had exceeded 200,000. our level in 2010.” plugs and conjunctival drug-eluting de- Since 1994, STAAR’s Implantable Collam- STAAR, which has been dedicated vices. er Lenses (ICLs) have been used in re- solely to ophthalmic surgery for more than Regulatory approval proves challeng- fractive eye surgery as an alternative to 25 years, designs, develops, manufac- ing for glaucoma drug-eluting delivery LASIK. Manufactured with STAAR’s propri- tures and markets implantable lenses for systems because of the cost involved in etary Collamer material, Visian ICLs pro- the eye. All of these lenses are foldable, proving safety and efficacy. vide a safe and effective alternative in which permits the surgeon to insert them In ophthalmology, implants are be- the permanent correction of myopia, hy- through a small incision. A lens used to re- ing developed with the goal of deliver- peropia, and in the case of the Toric ICL, place the natural lens after cataract sur- ing drugs to the back of the eye. Implants astigmatism. gery is called an intraocular lens or “IOL.” currently deliver anti-virals for AIDS-associ- “This milestone demonstrates that A lens used in refractive surgery as an al- ated eye viral retinitis or steroids for uveitis. STAAR’s ICL technology continues to ternative to LASIK is called an Implantable The technologies behind these systems transform the refractive market with in- Collamer Lens or “ICL.” provide for either short-term bioerodible creased share in the global surgical mar- STAAR has about 300 full-time employ- devices such as with Allergan’s Ozudex ket,” says Barry G. Caldwell, president ees and markets lenses in about 50 coun- or long tern non-erodible as with pSivi- and CEO of STAAR Surgical. “During the tries. With headquarters in Monrovia, Ca- da’s Iluvien. last half of 2010, we began shipping the lif., the company manufactures in Nidau, Allergan is developing an Ozudex-type new expanded version of the Vision ICL in Switzerland; Ichikawa City, Japan; Aliso system for glaucoma and pSivida is work- countries that accept CE Mark Certifica- Viejo, Calif.; and Monrovia, Calif. ing with its partner, Alimera Sciences, to tion. During 2010 Visian ICL sales increased develop Iluvien for diabetic eye disease. by 15%, while the LASIK segment contin- Obesity Currently there is not a long-term bioerod- ues to be challenged. We are most proud ible implant, according to Dr. Ashton. of the high level of patient satisfaction de- During the last 50 years, obesity has been “The big target for ocular drug delivery livered by STAAR’s technology for placing increasing at an alarming rate and is is a system to deliver big molecules such correction in the posterior segment, which now recognized by leading government as antibodies which are currently inject- avoids problems experienced with ante- health authorities, such as the Centers for ed directly into the eye every month,” Dr. rior segment phakic lenses. Of the over Disease Control (CDC) and National Insti- Ashton shares. 200,000 ICLs implanted over the past 17 tutes of Health (NIH), as a disease. In the Sensory implant/prosthetics are being years, over 14,000 of those have been in United States, obesity affects more than developed for people with profound vi- eyes for over 10 years. The overall safety 60 million individuals and is considered sion loss (Bionic Eye) and while this is prov- and patient satisfaction data is very en- the second-leading cause of preventing to be very difficult, these devices have couraging and differentiates the Visian able death. Worldwide, about 1.6 billion reached early clinical trials, according to product line from other refractive surgi- adults are overweight, and it is estimat- Dr. Ashton. cal options,” Mr. Caldwell shared. ed that obesity affects at least 400 mil- Drug-delivery implants are further ad- The company is focused on driving lion adults. vancing. Implants delivering drugs for six awareness of the benefits of its Visian ICL Obesity is caused by a wide range months to nine months for AIDS-associat- over LASIK surgery. In the fall of 2010, STAAR of factors including genetics, metabolic ed viral infections were approved in the initiated a direct-to-consumer marketing disorders, physical and psychological is- mid 1990s, such as Vitrasert, originally sold campaign that includes a series of seven sues, lifestyle, and poor nutrition. Millions by Chiron Corp. This was followed by Reti- videos that describe the features of its ICL of obese and overweight individuals first sert, a 2.5-year device FDA-approved for in a funny, easily accessible manner. turn to diet, fitness and medication to lose uveitis in 2005 and sold by Bausch and STAAR, in conjunction with ophthalmol- weight; however, these efforts alone are Lomb. Allergan’s Ozudex, a 30-day bio- ogists, rolled out these videos around the often not enough to keep weight at a lev- erodible implant, was approved for retinal world. In South Korea, where the ICL has el that is optimal for good health. Surgery vein occlusion in 2009. An NDA was sub- captured more than 10% of the refrac- is another increasingly viable alternative mitted by pSivida/Alimera’s for their 2-3 tive surgery market, STAAR’s distributor has for those with a Body Mass Index (BMI) of year Iluvien for diabetic macular edema invested in a direct-to-consumer educa- greater than 40. In fact, the number of in May 2011. The companies are hoping tional video that was shown with pre-mov- bariatric surgeries in the United States was for approval by year-end 2011. ie trailers during the first quarter of 2011. projected to reach about 400,000 annu- Dr. Ashton believes that the increas- “During 2011, it is important that we ally by 2010. ing pace of development of drug-deliv- continue to make progress toward regula- Allergan has joined the effort to fight 15 the growing obesity epidemic with a from hearing aids. They are electronic de- systems in the world. Founded in 1993 and portfolio of innovative medical devices vices, which bypass damaged hair cells partnered with Phonak under the Sono- to help achieve and support sustained in the inner ear, or cochlea, and stimulate va Group in 2009, AB develops cutting- weight loss, reduce health risks associat- the hearing nerve directly. edge cochlear implant technology that ed with obesity and help patients realize Cochlear implants are designed to re- restores hearing to the deaf. their goals for healthy living and wellness. store hearing, providing users with the best With sales in more than 50 countries, The LAP-BAND Adjustable Gastric Banding hearing experience possible, and are be- AB’s talented group of technologists and System is the first adjustable medical de- coming the standard of care with about professionals are driven to succeed, work vice for individualized weight loss and the 400 institutions in the United States provid- with integrity, and stay firmly committed first minimally invasive surgical approach ing this technology. to quality. approved in the United States by FDA. On Nov. 23, 2010, Advanced Bionics Cochlear Ltd. announced the addi- Approved outside of the United States, (AB) LLC officials notified FDA that the tion of the Cochlear Nucleus 5 (CP810) Allergan’s portfolio also includes the BIB company will voluntarily recall its HiRes Sound Processor and the Cochlear Nu- Intragastric Balloon System, which is a 90K cochlear implant device and is re- cleus 5 (CR110) Remote Assistant to its non-surgical alternative for the treatment trieving all unimplanted devices in dis- Nucleus 24 and Nucleus Freedom Im- of obesity. tribution. This action is being taken in re- plant family members in April 2011. The Given the serious immediate and long- sponse to two confirmed instances where Nucleus 5 System was launched in Sep- term consequences of the global obesi- the product experienced a malfunction tember 2009 and since that time, thou- ty epidemic, the company is committed requiring explanation. These recipients ex- sands of people have experienced the to programs to prevent obesity. In that perienced severe pain, overly loud sounds revolutionary innovations that the system quest, Allergan scientists are actively pur- and/or shocking sensations at 8-10 days provides. suing the development of next-genera- after initial activation of their device. The Nucleus 5 Sound Processor (CP810), tion products and technologies capable AB is continuing to evaluate the root along with the two-way Nucleus 5 Remote of providing high-quality, healthier, and cause(s) of the problem and is working Assistant (CR110), is designed to give users less traumatic long-term weight-loss treat- closely with the FDA to address questions access to their best hearing potential. ment solutions. and concerns as well as institute chang- FDA originally approved the Nucleus es to the product to ensure that the HiRes 5 System for adults and children with se- Cochlear Implants 90K offers the highest quality for patients vere-to-profound hearing loss. Working who use the device. This voluntary action with leading surgeons and audiologists Cochlear implants are a proven medical is being taken to ensure continued pa- worldwide, Cochlear developed the most option for children as young as 12 months tient safety and product quality. The risk advanced technology, including a small- old with profound hearing loss in both ears of any significant adverse medical events er and thinner device with an unparal- and for individuals who are 2 years or old- appears to be remote at present. leled capability to deliver superior hearing er with severe-to-profound hearing loss in AB is a global leader in developing one performance and better user comfort. each ear whom obtain little or no benefit of the most advanced cochlear implant The Nucleus 5 System offers the smallest, most water-resistant sound processor, Cochlear Ltd. the thinnest titanium cochlear implant, two-way remote assistant, SmartSound 2 technology and AutoPhone capability. Cochlear implants have the ability to restore hearing for individuals who are se- verely hard of hearing or profoundly deaf and who receive limited to no benefit from hearing aids. The new Nucleus 5 System is the most advanced cochlear implant system on the market for all ages. The system includes powerful features designed to restore hearing in deaf children so that they have the greatest potential to develop the spoken language skills necessary for school. Adults benefit from advanced features that deliver the best listening options for phone use, commu- nication in noisy environments and mu- sic enjoyment. “Cochlear has reached a significant milestone with the introduction of the Nu- Source: Cochlear Ltd. cleus 5 System,” shares Chris Smith, president of Cochlear Americas. We have 16 Cochlear Ltd. school and work settings, and going to concerts.” The Nucleus 5 System’s hearing performance record is achieved through a combination of exclusive features that have been perfected over the last 25 years. This includes a unique patented electrode array design that delivers a richer, more true-to life sound; the industry’s only SmartSound technology with the new Set It and Go program for everyday listening; and the world’s only fully integrated dual microphones for directional- ity and better sound quality in noisy situations. The system also features AutoPhone, the industry’s first automatic phone de- tection through an automatic telecoil for optimized phone use. Source: Cochlear Ltd. “What makes this new implant so re- markable is that it is significantly smaller built upon our industry-leading hearing from clinicians worldwide. It delivers new than Cochlear’s previous implant and any performance and reliability record with functionality while leveraging the existing others, resulting in a more natural fit for new, unique features designed to give us- stellar technology that the hearing health- adults and children,” says Bruce Gantz, ers greater flexibility and help them hear care industry has come to expect from M.D., professor and head of the Universi- better in difficult situations. We celebrate the market leader. ty of Iowa Department of Otolaryngol- this milestone with the dedicated clini- “Advancements in cochlear implant ogy, Head and Neck Surgery. cians who have helped us positively im- technology give users greater opportuni- Cochlear is the world leader in implant- pact the lives of so many people.” ties to participate in the hearing world,” able hearing solutions. Since launching Built on the industry benchmark set by according to Jace Wolfe, Ph.D., audiolo- the first multichannel cochlear implant Cochlear’s previous generation system, gist at Hearts for Hearing Foundation. system more than 25 years ago, Cochle- preliminary research shows that the Nu- “After having been involved in the glob- ar has brought the miracle of sound to cleus 5 System outperforms other cochle- al clinical validation of the new Nucleus more than 180,000 individuals with hear- ar implant systems with higher speech per- 5 Sound Processor, I have seen first-hand ing loss. Cochlear Americas markets the formance results than reported for other how it will enable users to more fully ex- No. 1-selling products Baha implantable systems. The new system is the result of perience everyday hearing activities like bone-anchored hearing device and Nu- several years of development and input talking on the telephone, conversing in cleus cochlear implant technology. IMPLANT COMPANIES REVIEW

This section of the report profiles some of the world’s leading companies AS WELL AS UP-AND-COMERS IN THE AREA OF Implants; some companies were already detailed on the preceding pages of this report.

Abbott Laboratories an alternative to a more invasive surgical incision made in the groin. The procedure procedure for patients at moderate risk of is less invasive than surgery, though stents Abbott is a global, broad-based health complications from the surgery. Before this carry their own risks, including blood clots care company devoted to the discovery, marketing approval, the stent had only and rupture of the blood vessel. development, manufacture and mar- been approved for those at high risk. About 450,000 people in the United keting of pharmaceuticals and medical Endarterectomy is a surgery which in- States have carotid artery disease, or products, including nutritionals, devices volves cutting open the neck artery and plaque buildup in the arteries that carry and diagnostics. The company employs scraping out plaque formations that can blood to the brain. Roughly 60% of those nearly 90,000 people and markets its prod- block blood flow. The stent, however, patients are eligible to receive the stent ucts in more than 130 countries. can be implanted with only a small inci- under the new FDA-approved indication. During May 2011, FDA expanded its sion. FDA originally approved Acculink in The other 40% were covered under the approval of Abbott’s Acculink, an artery- 2004. prior FDA approval. opening stent, to a larger group of pa- Stents are mesh-metal tubes used to FDA based the expanded approval tients at risk for stroke caused by plaque hold open arteries where plaque is begin- on a 10-year study of 2,500 patients that buildup in the neck arteries. The regulato- ning to form. They are threaded up into found similar rates of death, stroke and ry agency approved the Acculink stent as the artery with a catheter through a small heart attack between patients getting a 17 Abbott Laboratories making it widely available in Europe by the end of 2012.” CE Mark approval for Absorb in Eu- rope was supported by data from the Absorb clinical trials, which included patient follow-up out to three years. To further study the device in an expanded population, Abbott plans to initiate a randomized, controlled clinical trial in Europe during 2011. The study will enroll about 500 patients at 40 centers throughout Europe and will compare Absorb to Abbott’s XIENCE PRIME, which together with XIENCE V, is the market-leading drug-eluting stent system in Europe. The clinical trial will provide additional data to support European commercialization and reimbursement activities. A global trial, including the United States and other ge- Source: Abbott Laboratories ographies, is planned for 2011. In addition to clinical-trial product, Ab- stent and those having surgery. The study no other drug eluting coronary device has sorb will be made available in select sizes was co-funded by the National Institutes been able to do before – completely dis- to a limited number of centers in Europe of Health and Abbott Laboratories. solve and potentially restore natural ves- during 2011 and into 2012. This will enable In January 2011, an FDA panel of out- sel function in a way not possible with per- physicians in these centers to increase side experts voted 7-3 that Acculink’s ben- manent metallic implants.” their clinical experience with the tech- efits outweighed its risks for the new use. Absorb is made of polylactide, a prov- nology and to continue to develop the As a condition of approval, FDA requires en biocompatible material that is com- therapy. A full-scale European commer- Abbott to track new patients with the monly used in medical implants such as cial launch of Absorb with a broad size stent for at least three years to determine resorbable sutures. Since a permanent matrix is planned by the end of 2012. the safety of the device once implanted. metallic implant is not left behind, a pa- The Absorb trial is the world’s first clini- Among other variables, the company will tient’s vessel treated with Absorb may cal trial evaluating a drug-eluting BVS for report how patients 80 years and older re- ultimately have the ability to move, flex coronary artery disease. Abbott is the first spond to treatment. and pulsate similar to an untreated ves- company with long-term, four-year clini- Abbott reported total stent sales in ex- sel. Restoration of these naturally occur- cal data on a complete patient set eval- cess of $2 billion in 2010. ring vessel functions, or vascular restora- uating the safety and performance of a On Jan. 10, 2011, Abbott received CE tion therapy (VRT), is one of the features drug-eluting BVS. The Absorb trial is a pro- Mark approval for the world’s first drug- that makes Absorb a significant innova- spective, non-randomized (open label), eluting bioresorbable vascular scaffold tion for patients in the treatment of cor- two-phase study that enrolled 131 pa- (BVS) for the treatment of coronary ar- onary artery disease. In addition, con- tients from Australia, Belgium, Denmark, tery disease. Abbott’s BVS device restores tinuing research indicates that the need France, the Netherlands, New Zealand, blood flow by opening a clogged vessel to administer long-term dual anti-plate- Poland and Switzerland. and providing support to the vessel un- let therapy to patients may be reduced Key endpoints of the study include as- til the device dissolves within about two because the temporary scaffold is com- sessments of safety – major adverse cardi- years, leaving patients with a treated ves- pletely resorbed. ac events (MACE) and treated-site throm- sel free of a permanent metallic implant. “Our Absorb technology has the po- bosis rates – at 30 days and at six, nine, Abbott’s bioresorbable vascular scaffold tential to revolutionize the treatment of 12 and 24 months, with additional annu- device will be commercialized under the coronary artery disease – with the pros- al clinical follow-up for up to five years, as brand name Absorb. pect for positive therapeutic outcomes well as an assessment of the acute perfor- “The CE Mark approval for Absorb in resulting from its unique ability to treat a mance of the BVS device, including suc- Europe is a significant accomplishment blocked vessel, potentially restore natural cessful deployment of the system. Other that validates the impressive clinical re- vessel function and disappear within ap- key endpoints of the study include imag- sults that have been observed with this proximately two years after implant,” says ing assessments by angiography, intravas- device,” says Patrick W. Serruys, M.D., Robert B. Hance, senior VP, vascular, Ab- cular ultrasound (IVUS), optical coherence Ph.D., professor of interventional cardiol- bott. “Receiving CE Mark is a significant tomography (OCT), and other state-of- ogy at the Thoraxcenter at Erasmus Uni- milestone on the path to providing pa- the-art invasive and non-invasive imag- versity Hospital in Rotterdam, the Nether- tients with new treatment options for coring modalities at six, 12 and 18 months lands. “Abbott’s Absorb has the potential onary artery disease. Abbott is commit- and at two, three and five years. to change the way patients with coronary ted to building the clinical and economic Results from the first stage of the Absorb artery disease are treated, as it does what benefits of this therapy in anticipation of trial with 30 patients demonstrated that 18 Abbott’s BVS successfully treated coro- Allergan Inc. tion alternatives such as diet and exer- nary artery disease and was resorbed into cise and pharmacotherapy, and have the walls of treated arteries within about Allergan is a multi-specialty health-care a Body Mass Index (BMI) of 30-40 and at two years. Patients in this first stage of the company focused on discovering, de- least one obesity related comorbid con- Absorb trial experienced no blood clots veloping and commercializing innova- dition. Currently, about 37 million Ameri- (thrombosis) out to four years and no new tive pharmaceuticals, biologics, medical cans have a BMI of 30-40 and at least one MACE between six months and four years devices and over-the-counter consumer comorbid condition, underscoring obesity (3.4% at four years). products that enable people to live life to as a growing health epidemic in the Unit- Nine-month results from the 101 pa- its greatest potential. ed States and the need for additional ef- tients enrolled in the second stage of the As a leader in the medical-aesthetics fective treatment options. Absorb trial showed that the MACE rate industry, Allergan is committed to provid- “Given the proven and significant remained consistent at 5% at nine months. ing the highest-quality education to wom- health ramifications of obesity, we are There were no reports of blood clots in any en considering breast aesthetic surgery pleased with the FDA’s decision to ex- of the 101 patients at nine months. so that she, along with her surgeon, can pand the use of the LAP-BAND System,” The Absorb Extend trial is a single-arm make an informed and educated de- says Frederick Beddingfield, M.D., VP of study that will evaluate patients at up to cision about what is right for her. Look- clinical research and development, Aller- 100 centers in Europe, Asia Pacific, Can- ing ahead, the company will continue gan. “Although this label expansion repre- ada and Latin America. The clinical trial to lead the science-based innovation in sents a significant advancement in obesi- will enroll about 1,000 patients with more the area of breast aesthetics by offering ty treatment, the LAP-BAND System is not complex coronary artery disease. women and their surgeons more options intended for everyone. The LAP-BAND Abbott’s bioresorbable technology with additions to the company’s exten- System does represent a potential treat- delivers everolimus, an anti-proliferative sive collection of high-quality breast-im- ment option for those patients with obe- drug. Everolimus is developed by Novar- plant devices. sity and a related health condition, who tis Pharma AG and is licensed to Abbott In partnership with the medical com- have failed more conservative weight- by Novartis for use on its drug-eluting vas- munity, the company brings scientific loss therapies, such as diet and exercise cular devices. Everolimus has been shown excellence and rigor to deliver leading and pharmacotherapy, and under con- to inhibit treated-site neointimal growth products that improve patient outcomes. sultation with their physician, have deter- in the coronary vessels following vascular According to management, Allergan mined that weight-loss surgery is the next device implantations, due to its anti-pro- goes above and beyond to provide ed- best treatment option.” liferative properties. ucation and information, with the highest Obesity is the second-leading cause of Absorb is made of polylactide, a prov- level of integrity, that helps patients to fully preventable death in the United States, en biocompatible material that is com- understand the choices available to them trailing only to smoking. Given its known monly used in medical implants such and make well-informed treatment deci- correlation to life-threatening comorbid as resorbable sutures. The device is de- sions with their doctors. conditions, such as heart disease, stroke, signed to restore blood flow by open- The company offers a number of lead- Type 2 diabetes, high blood pressure, ing a clogged vessel and providing sup- ing products, including: Botox, Restasis, Lu- sleep apnea and even premature death, port to the vessel. Once the vessel can migan, the Juvederm family of dermal obesity is a disease that requires medical remain open without the extra support, fillers, and the LAP-BAND Adjustable Gas- treatment. Medical research has found Absorb is designed to slowly metabolize tric Banding System. that, if left untreated, those individuals and eventually be resorbed by the body. For more than 25 years, Natrelle gel who are currently obese will likely remain Since a permanent implant is not left be- and saline breast implants have been obese. However, not all weight-loss treat- hind, a vessel treated with Absorb may available to women in more than 60 ments are effective over the long term – ultimately have the ability to move, flex countries for breast augmentation, revi- as a preponderance of data, published and pulsate similar to an untreated ves- sion and reconstructive surgery. literature and scientific research have sel. Restoration of these naturally occur- The Natrelle Collection offers women found that diet and exercise is unsuccess- ring vessel functions, or vascular restora- the industry’s widest range of safe and ful in 80% to 85% of patients at one year. tion therapy (VRT), is one of the features high-quality breast-implant options. From “As a surgeon, I see patients every day that makes Absorb a significant innova- saline and silicone gel filler, to smooth and who have been obese for years and have tion for patients in the treatment of coro- textured surfaces and varying shapes, to tried several diet and exercise programs nary artery disease. Absorb is under de- low, moderate and high profile (projec- without success,” says Robert Michaelson, velopment and is not available for sale in tion) and a range of volumes, women cur- M.D., Ph.D., Northwest Surgical Weight the United States. rently have more options than ever be- Loss Surgery in Everett, Wash., and clin- Abbott Vascular is a global leader in fore in breast aesthetics. This is critical to a ical-trial investigator. “These patients fre- cardiac and vascular care with market- woman’s ability to achieve an individual- quently feel judged by their weight, as leading products and an industry-leading ized, aesthetic result based on her unique obesity is often viewed as a lack of will pipeline. Abbott Vascular offers a com- body type and surgical goals. power, which it is not. Obesity is a disease, prehensive cardiac and vascular devices FDA approved expanded use of the which requires medical treatment, but un- portfolio, including products for coronary LAP-BAND System, Allergan’s gastric fortunately diet and exercise alone do not artery disease, vessel closure, endovascu- band, for adults with obesity who have work for everyone. The LAP-BAND System lar disease, and structural heart disease. failed more conservative weight-reduc- meets an unmet clinical need, as it pro- 19 vides an effective treatment option, which in the second year of the study. This lev- first FDA-approved device for bariatric sur- is used in combination with diet and exer- el of weight loss exceeds what is typical- gery in patients with a BMI of 30-35. Dur- cise, to enable sustained weight loss.” ly evident with more conservative treating the past 18 years, more than 650,000 The regulatory approval to expand ment, such as diet and exercise. procedures have been performed, lead- the use of the LAP-BAND Adjustable Gas- The secondary endpoints for the study ing to 2-plus million patient years of expo- tric Banding System was based on a re- were improvement in obesity-related co- sure for the device. view of full 12-month data and available morbid conditions of dyslipidemia, Type 2 24-month data from a prospective, sin- diabetes, and hypertension and improve- Boston Scientific Corp. gle-arm, non-randomized, multi-center ment in Quality of Life (QoL). Eighty-five five year-study and the more than 17- percent of subjects in the clinical trial had Boston Scientific is a worldwide develop- year safety and effectiveness record of at least one comorbid condition. In terms er, manufacturer and marketer of medi- the LAP-BAND System. Following approv- of improvement in comorbid conditions cal devices. The corporation’s products al, the patients in the trial will continue to of dyslipidemia, Type 2 diabetes and hy- are used in a broad range of interven- be followed for a total of five years. pertension, 22% to 33% of patients with tional medical specialties. In addition, there will be an analy- those conditions saw their conditions re- On May 11, 2011, Boston Scientific an- sis of the outcomes of patients with BMI solved after one year. About 60% of pa- nounced that a jury in the District Court for of 30 to 40 recorded in the Bariatric Out- tients, who had a comorbidity at baseline, the District of Delaware found that Cordis comes Longitudinal Database (BOLD). had improvement of at least one comor- owes Boston Scientific about $19.5 million Established in 2007 by the Surgical Re- bid condition by month 12. Also, there was for infringing its Jang patent. This patent view Corp., BOLD is the world’s largest a statistically significant improvement in covers intellectual property associated and most comprehensive repository of QoL at months six and 12. with coronary stent technologies. The jury clinical bariatric surgery patient informa- During the 12-month study period, the awarded $18.5 million in lost profits and tion. The database contains more than types of Adverse Events (AEs) reported $1 million in reasonable royalties to Bos- 300,000 patients, and 12,000 new patients by patients were as expected for the sur- ton Scientific. are added monthly. The BOLD analysis will gical procedure, such as vomiting, dys- Boston Scientific brought suit against consist of examining the explant rates, ad- phagia, and gastroesophageal reflux Cordis for patent infringement during De- verse events, weight loss, and changes disease (GERD). Most AEs were mild to cember 2009, which was shortly after the in the status of obesity-related comorbid moderate in severity and resolved in less U.S. launch of Cordis’ 2.25 mm Cypher conditions observed in LAP-BAND System than four weeks. Stent. On April 13, 2011, the Delaware patients during the course of 10 years. The LAP-BAND System was originally Court ruled that, as a matter of law, Cordis The LAP-BAND System study, initiated by approved by FDA in 2001 for use in severe- infringed Boston Scientific’s Jang patent Allergan, is a prospective, single-arm, non- ly obese adults, individuals with a BMI of and later found that Cordis’ infringement randomized, multi-center five-year study 35 with at least one severe comorbid con- was willful. conducted under an FDA-approved In- dition or a BMI of 40, or those who are at “We are pleased to see the jury rec- vestigational Device Exemption. The study least 100 pounds or more overweight. The ognize the value of our intellectual prop- was performed to determine the safety LAP-BAND System has been approved in- erty,” Mr. Kucheman said. “This is an im- and effectiveness of the LAP-BAND Sys- ternationally since 1993. The system is the portant outcome in protecting our market tem as a treatment for obesity in adult patients with a BMI of ≥ 30 and < 40, with and without comorbid conditions. The study was initiated in 2007, and included 149 patients who had a mean excess weight of 62.8 pounds and had been obese on average for 17 years and who underwent the LAP-BAND System procedure. The criterion for success was at least 40% of patients achieving clinically meaningful weight loss at the 12-month mark. Clinically meaningful weight loss was defined as at least 30% Excess Weight Loss (EWL). Results from the 12-month dataset demonstrate clinically significant weight loss in this patient group with a low risk of serious complications. Specifically, 83.9% of the patients lost at least 30% of their excess weight at the one-year mark, more than twice the percentage required for success. More than 65% of the patients in the clinical trial were no longer obese af- Source: Boston Scientific ter one year. Weight loss was maintained 20 position in small-vessel, drug-eluting stents and improving outcomes for patients un- Mark countries where the product was against infringing products.” dergoing cardiac ablation procedures.” approved in May 2010, the ION Stent Sys- On May 3, 2011, Boston Scientific re- In the United States, the Blazer Open-Ir- tem is commercialized as the TAXUS El- ceived CE Mark approval and first use in rigated Catheter is an investigational de- ement Paclitaxel-Eluting Coronary Stent Europe of its Blazer Open-Irrigated Cath- vice, limited by applicable law to inves- System. The ION Stent is backed by the eter. This radiofrequency ablation (RFA) tigational use only and not available for proven safety and efficacy of the TAXUS catheter is designed for treating a vari- sale. clinical program, which spans 10 years of ety of arrhythmias such as atrial fibrilla- On April 25, 2011, Boston Scientif- research in nearly 50,000 patients in 28 tion, atrial flutter, ventricular tachycardia ic gained FDA approval and launch of pre-market and post-market studies. and other supraventricular tachycardias. the ION Paclitaxel-Eluting Platinum Chro- The ION Stent has been evaluated in The product was launched during the first mium Coronary Stent System. This is the the PERSEUS trial, which had 12-month re- quarter of 2011 in select CE Mark coun- company’s third-generation drug-eluting sults reported in March 2010 demonstrat- tries. stent technology. The ION Stent System in- ing positive safety and efficacy outcomes The Blazer Open-Irrigated Catheter incorporates a unique platinum chromium in workhorse lesions compared to the TAX- tegrates Total Tip Cooling Design with (PtCr) alloy designed specifically for cor- US Express2 Stent System. The PERSEUS the high-performance Blazer Catheter onary stenting and intended to improve clinical program compared the ION Stent platform. Total Tip Cooling Design is in- the acute performance of coronary stent to prior-generation Boston Scientific stents tended to consistently cool the entire tip implantation in the treatment of coronary in more than 1,600 patients in two parallel electrode during radiofrequency energy artery disease. trials at 90 centers worldwide. In April 2011, delivery. This is achieved through both in- The ION Stent System features an in- results from an analysis of pooled patient- ternal cooling and external washing of novative PtCr alloy and new stent design level data from 2,298 patients enrolled in the tip electrode, which is designed to to offer greater strength, enhanced de- the PERSEUS and TAXUS ATLAS clinical trials reduce coagulum at the proximal edg- liverability and exceptional visibility. The showed that the ION Stent demonstrates of the tip. thin-strut stent is designed for improved ed significantly lower rates of major ad- The first European procedure using conformability, minimal recoil, and uni- verse cardiac events, target lesion failure the Blazer Open-Irrigated Catheter was form lesion coverage and drug distribu- and myocardial infarction compared to performed at the Hopital Cardiologique tion. The advanced low-profile delivery the TAXUS Liberte Paclitaxel-Eluting Stent du Haut–Leveque in Bordeaux–Pessac, system facilitates precise delivery of the System. France, under the supervision of Prof. Mi- stent across challenging lesions. “The positive clinical data from our chel Haissaguerre, M.D. “I look forward to using the ION Stent in PtCr Series trials support the acute per- “The excellent cooling profile, coupled my daily practice, and I believe our pa- formance benefits provided by our new with the high performance Blazer plat- tients will benefit from its improved acute platinum chromium stent platform,” re- form, makes this catheter an important performance,” says Louis Cannon, M.D., ports Keith D. Dawkins, M.D., senior VP additional option for performing com- FACC, FACA, Heart and Vascular Institute and chief medical officer for Boston Sci- plex ablations,” says Sebastien Knecht, Program Director at Northern Michigan entific’s cardiology, rhythm and vascular M.D., Ph.D., who performed the proce- Regional Hospital in Petoskey, Mich. group. “The PERSEUS data confirmed that dure with Frederic Sacher, M.D. “The tip “The platinum chromium alloy represents the proven TAXUS drug and polymer com- temperatures were lower than conven- a leap forward in materials technology bination has been successfully transferred tional open-irrigated catheters during RF and will address many of the limitations to the advanced ION Stent platform with delivery, and the bidirectional catheter found in older stent alloys. Exceptional excellent performance and comparable performed very well, accessing the pul- stent deliverability offers cardiologists the safety and efficacy.” monary veins with dependable steering potential to treat patients with difficult-to- In October 2009, the company re- and tip stability.” reach lesions.” ceived CE Mark approval for the PROMUS Affecting more than 4.5 million Europe- According to Mr. Kucheman, “The Element Everolimus-Eluting Stent System. ans, atrial fibrillation is an arrhythmia asso- company has made significant invest- The company hopes to gain FDA approv- ciated with a rapid rhythm in the upper ments in the platinum chromium alloy, al for the PROMUS Element Stent System chambers of the heart. Patients are most and our success with the PtCr Stent Se- in mid 2012. The product incorporates the often treated with anti-arrhythmic drugs, ries in Europe and other international mar- same platinum chromium alloy, innova- which can often cause adverse side ef- kets has confirmed that stent material re- tive stent design and advanced catheter fects. Cardiac ablation with an RFA cath- ally matters. We believe the PtCr platform delivery system of the ION Stent System. eter is increasingly becoming an option sets a new standard for drug-eluting stent In the United States, the PROMUS Element for patients who cannot tolerate these performance and represents the future of Stent System is an investigational device, medications. coronary stenting.” limited by applicable law to investigation- “The CE Mark approval, first use and The ION Stent offers physicians and al use only and not available for sale. launch of the Blazer Open-Irrigated Cath- their patients the broadest size matrix on On April 5, 2011, Boston Scientific an- eter in Europe are important milestones in the market, and includes both monorail nounced the start of patient enrollment our continued focus on advancing cardi- and over-the-wire versions. Sizes range in in the SuperNOVA clinical trial. This inter- ac ablation technology,” Mr. Kucheman diameter from 2.25 mm to 4.00 mm and national, prospective, single-arm, non- stated. “We are committed to expanding lengths vary from 8 mm to 38 mm. randomized trial is evaluating the safety our European electrophysiology business Outside the United State, including CE and effectiveness of the INNOVA Self-Ex- 21 panding Bare-Metal Stent System in pa- ployment options and radiopaque mark- overall quality of life for patients with pe- tients with stenosis of the superficial femo- ers to enhance ease of use. The INNOVA ripheral artery disease.” ral artery (SFA) or proximal popliteal artery Stent is 6F compatible and ranges from 5 The INNOVA Stent System received CE (PPA). Enrollment is planned for up to 300 mm to 8 mm in diameter and 20 mm to Mark in March 2011, and the company patients at 50 sites based in the United 200 mm in length. planned to begin marketing the product States, Canada and Europe. The first pa- “Treating arteries above the knee is in the EU and other countries in the sec- tient was enrolled in the trial last week by difficult because the challenging anato- ond quarter of 2011. In the United States, Subhash Banerjee, M.D., associate pro- my can lead to stent fractures and high- INNOVA is an investigational device, lim- fessor of medicine and chief of cardiol- er restenosis rates,” states Richard J. Pow- ited by applicable law to investigational ogy at the VA Medical Center located ell, M.D., section chief of vascular surgery use only and not available for sale. in Dallas. at Dartmouth-Hitchcock Medical Cen- On March 7, 2011, Boston Scientific re- The INNOVA Stent System is designed ter in Lebanon, N.H., and global princi- ceived CE Mark for its OMEGA Platinum to treat peripheral vascular lesions in ar- pal investigator of the SuperNOVA tri- Chromium Bare-Metal Coronary Stent teries above the knee, specifically the SFA al. “I believe the INNOVA Stent offers a System, the company’s third-generation and PPA. The product consists of a nitin- unique design that provides excellent ra- coronary stenting technology. OMEGA ol, self-expanding bare-metal stent load- dial strength while remaining flexible and incorporates Boston Scientific’s unique ed on an advanced low-profile delivery durable, which is critical to sustaining pa- platinum chromium (PtCr) alloy designed system. The innovative architecture fea- tency in treated SFA and PPA lesions.” specifically for coronary stenting and is in- tures a closed-cell design at each end of “The INNOVA Stent is engineered to tended to provide interventional cardi- the stent for improved radial force and offer an advanced solution in treating ologists with a bare-metal stent with im- fracture resistance, and an open-cell de- blockages within these critical arteries,” proved acute performance in treating sign along the stent body that does not says Joe Fitzgerald, senior VP and presi- patients with coronary artery disease. The compromise flexibility. Stent deliverability dent of Boston Scientific’s Endovascular company immediately began marketing is enhanced with a tri-axial catheter shaft Unit. “Its design is intended to improve the OMEGA Stent System in the European designed to provide added support and blood flow and provide greater long-term Union and other CE Mark countries. placement accuracy as well as dual de- stent durability, ultimately improving the “In my experience, the platinum chro-

Source: Boston Scientific

22 mium alloy and design used in the OME- for the TAXUS Element Stent System dur- ports Ray Elliott, president and CEO of Bos- GA Stent offer excellent deliverability, vis- ing May 2010. ton Scientific. “Our PtCr stent technology ibility and conformability while improving The TAXUS Element Stent System will be platform provides a significant advan- radial strength and reducing stent recoil,” commercialized in the United States as the tage in this fast-growing market.” says Antonio Colombo, M.D., director of ION Paclitaxel-Eluting Platinum Chromium The PROMUS Element Stent is being the cardiac catheterization laboratory Coronary Stent System and the PROMUS evaluated in the PLATINUM clinical trial, at Columbus Hospital and San Raffa- Element Stent System will be commercial- which completed enrollment of 1,532 pa- ele Hospital in Milan, Italy. “The OMEGA ized as the PROMUS Element Plus Everoli- tients in September 2009 at more than 140 Stent and platinum chromium alloy offer mus-Eluting Platinum Chromium Coronary sites worldwide. PLATINUM is a random- meaningful performance improvements Stent System. Both systems incorporate ized, controlled, pivotal trial designed to without the tradeoffs associated with old- the same platinum chromium alloy, inno- support FDA and Japanese Ministry of er stent alloys.” vative stent design and advanced cath- Health, Labor and Welfare (MHLW) ap- The OMEGA Stent System is part of Bos- eter delivery system. proval of the PROMUS Element Stent Sys- ton Scientific’s PtCr Stent series, which in- The company anticipates FDA approv- tem. In September 2010, data were pre- cludes the TAXUS Element Paclitaxel-Elut- al for the ION Stent System in mid 2011, sented on 30-day and nine-month clinical ing Stent System and PROMUS Element and mid 2012 approval for the PROMUS outcomes and nine-month quantitative Everolimus-Eluting Stent System. All three Element Plus Stent System. CE Mark ap- coronary angiography (QCA) and intra- stents feature the novel PtCr alloy and an proval for the PROMUS Element Plus Stent vascular ultrasound (IVUS) supporting the innovative stent design, which combine System is expected in the second half of safety and efficacy of the PROMUS Ele- to offer greater radial strength and flexi- 2011. In Japan, the company expects ap- ment Stent. bility while reducing stent recoil. The high- proval for the TAXUS Element Stent System The TAXUS Element Stent is being eval- er density alloy provides superior visibility in late 2011 or early 2012, and mid 2012 for uated in the PERSEUS trial, which had while permitting thinner struts compared the PROMUS Element Stent System. 12-month results reported in March 2009, to prior-generation stents. The enhanced In the United States, the OMEGA Stent demonstrating positive safety and effica- delivery system features a dual-layer bal- System, ION Stent System and PROMUS cy outcomes in workhorse lesions for the loon and is engineered to improve access Element Plus Stent System are investiga- TAXUS Element Stent System compared to challenging lesions. tional devices, limited by applicable law to the TAXUS Express2 Stent System. The “The platinum chromium PROMUS El- to investigational use only and not avail- PERSEUS clinical program compared the ement and TAXUS Element Stents have able for sale. TAXUS Element Stent to prior-generation been well received by physicians since On Feb. 17, 2011, Boston Scientific Boston Scientific stents in more than 1,600 their launch in CE Mark countries, and we launched the PROMUS Element Everoli- patients in two parallel trials at 90 centers are pleased to offer a bare-metal coro- mus-Eluting Coronary Stent System and worldwide. nary stent built on the same PtCr plat- TAXUS Element Paclitaxel-Eluting Coronary form,” says Mike Phalen, executive VP Stent System in India. India is one of the Johnson & Johnson and president, International, for Boston fastest-growing DES markets in the world, Scientific. “The OMEGA Stent is the lat- with the number of coronary drug-elut- The Johnson & Johnson Family of Com- est example of our commitment to con- ing stents implanted annually estimated panies is the world’s most comprehen- tinued innovation in coronary stenting. at more than 150,000. In 2010, the com- sive and broadly-based manufacturer of We are confident our platinum chromi- pany received approval from the Drugs health-care products. Products in the im- um technology will strengthen our world- Controller General of India to market the plant category include hip-replacement wide stent market leadership.” Element Systems. implants and coronary stents. Johnson & Dr. Dawkins says, “The positive clinical The PtCr Element Stent series features Johnson embraces research and science data from our PtCr (Element) trials support a novel platinum chromium alloy and in- – bringing innovative ideas, products and the acute performance benefits provided novative stent design, which combine services to advance the health and well- by our new platinum chromium stent plat- to offer greater radial strength, flexibility being of people. J&J staffs about 115,000 form. The OMEGA Stent complements the and visibility while reducing stent recoil. employees at more than 250 Johnson & PtCr Stent series, and gives interventional The stent geometry helps create consis- Johnson companies. cardiologists the option to treat patients tent lesion coverage and drug distribu- On April 27, 2011, J&J and Synthes Inc., with a paclitaxel, everolimus or bare-met- tion while improving deliverability, which a premier global manufacturer of ortho- al stent.” is enhanced by an advanced catheter pedic devices, entered into a definitive The OMEGA Stent is offered in 48 siz- delivery system. The higher-density plati- agreement. J&J will acquire Synthes for es, ranging in diameter from 2.25 mm to num chromium alloy provides exceptional CHF159 per share, or $21.3 billion. Upon 4.50 mm and lengths of 8 mm to 32 mm. visibility while enabling the use of thinner completion of this transaction, Synthes Boston Scientific has the industry’s most struts compared to prior-generation stents and the DePuy Companies of Johnson & comprehensive coronary stent portfolio, without compromising strength. Johnson together will comprise the larg- offering physicians and their patients the “A key component of our growth strat- est business within the Medical Devices broadest size matrix and the only two- egy involves expanding our footprint in and Diagnostics segment of Johnson & drug platform. The company received emerging markets like India, where we Johnson. CE Mark approval for the PROMUS Ele- are making significant investments in sales, Under the terms of the agreement, ment Stent System in October 2009 and distribution and clinical infrastructure,” re- each share of Synthes common stock, 23 subject to certain conditions, will be ate the most innovative and comprehen- Foundation. I am very pleased and excit- exchanged for CHF55.65 in cash and sive orthopaedics business in the world ed that my life’s work will continue as part CHF103.35 in Johnson & Johnson com- and enable us to better serve clinicians of Johnson & Johnson.” mon stock. The transaction has an esti- and patients worldwide,” said Bill Weldon, According to Michel Orsinger, presi- mated net acquisition cost of $19.3 bil- chairman and CEO of Johnson & John- dent and CEO of Synthes, “Synthes and lion as of the close of business on April 26, son. “Orthopaedics is a large and growing Johnson & Johnson are both respected 2011, based on Synthes’ roughly 119.5 mil- $37 billion global market and represents as global leaders, sharing the mission of lion fully diluted shares outstanding and an important growth driver for Johnson & delivering the highest possible standard about $2 billion in cash on hand as of sign- Johnson. Synthes is widely respected for of patient care and also have very sim- ing. its innovative high-quality products, world- ilar company cultures. The combination The boards of directors of Johnson & class R&D capabilities, its commitment to presents a significant opportunity to joint- Johnson and Synthes approved the trans- education, the highest standards of ser- ly bring our products, services and educa- action. Dr. Hansjorg Wyss, Synthes founder vice, and extensive global footprint.” tional offerings to the next level. Together, and chairman of the board, and related Dr. Wyss stated, “The combination of we will be a more attractive and exciting parties agreed to vote shares represent- Synthes and Johnson & Johnson, two or- company for our employees, and a more ing not less than 33% of Synthes common ganizations focused on the best patient resourceful partner for our customers.” stock in support of the transaction. care and improving health care through- Synthes and DePuy would be well- DePuy offers one of the most diverse out the globe, is a very exciting and prom- positioned to address significant market orthopedics portfolios in the industry. Syn- ising one. It will ensure that physicians and trends. These include an aging popula- thes is recognized for its innovations in hospitals will receive the utmost possible tion, patient desire to remain active, in- trauma, spine, cranio-maxillofacial and support in cooperation with the AO Foun- creasing rates of obesity and the resulting power tools. Together, the companies dation to help their patients. The Synthes impact on joint disease, growing treat- will offer surgeons and patients a unique family will find a great home and support ment demands in emerging markets, and breadth and depth of technology and from Johnson & Johnson and will contin- a movement toward earlier intervention. service worldwide to meet their orthopae- ue operating with its distinct culture and Specifically, DePuy and Synthes to- dic needs. excellence in product development and gether would bring: product develop- “DePuy and Synthes together will cre- physician education together with the AO ment capabilities and robust pipelines

Johnson & Johnson

Source: J&J

24 from the two organizations, as well as date individual anatomic variation in pa- ple with conditions limiting rehabilitation potential for technology convergence tients. should not have these surgeries. Patients across Johnson & Johnson that would In addition to receiving 510(k) clear- should consult with an orthopaedic sur- target transformational innovation to en- ances for the A.L.P.S. Total Foot and AF- geon to determine if joint reconstruction hance patient care; global reach to bring FIXUS Nail Systems, DePuy announced the and replacement surgery is appropriate a broader portfolio of orthopedics solu- launch of GLOBAL ADVANTAGE+. The for them. tions to more people around the world in new instrumentation system is for shoul- On Feb. 14, 2011, DePuy Orthopaedics developed and particularly in emerging der replacement surgery for use with the received 510(k) clearance from FDA for markets; and renowned leadership and company’s GLOBAL ADVANTAGE shoul- use of the RECLAIM Revision Femoral Hip expertise in professional education, and der replacement implant. System in cementless hip revision surgery. commitment to serving the medical com- “DePuy Orthopaedics has invested Engineered to deliver a high level of im- munity. heavily to engineer solutions that help sur- plant strength, the RECLAIM System is a The transaction is expected to close geons address the individual needs of pa- compelling solution for patients facing re- during the first half of 2012. The deal is sub- tients facing foot, hip or shoulder surgery,” vision total hip replacement surgery. ject to clearance under the Hart-Scott- explains Gordon Van Ummersen, World- “The RECLAIM Revision Hip System is Rodino Antitrust Improvements Act, ap- wide President of Trauma and Extremities, designed to address clinical needs for proval by the European Commission and DePuy Orthopaedics. “These new devic- patients facing complex revision total hip regulatory approval in certain other juris- es represent significant advances in tech- replacement procedures,” explains Mike dictions, as well as other customary clos- nology and surgical efficiency.” Barker, worldwide VP, product developing conditions. The merger will require the The A.L.P.S. Total Foot System includes ment, DePuy Orthopaedics.“This system approval of Synthes’ stockholders, and will nine anatomically contoured plates and has been studied extensively through an- be effected by way of a statutory merger both locking and non-locking screw op- alytic techniques and rigorous laboratory under Delaware law. Since Synthes is in- tions for use in reconstructive and trau- testing and has demonstrated very prom- corporated outside of Switzerland, Swiss ma procedures of the forefoot, midfoot ising capabilities, particularly with respect takeover regulations do not apply to the and hindfoot. The new plating technolo- to construct fatigue strength and torsion- merger. gy enables intra-operative customization al stability. We are very pleased to begin DePuy Orthopaedics, DePuy Spine, to accommodate patient-specific anat- providing this exciting new treatment op- DePuy Mitek Inc. and Codman & Shurtl- omy without compromising strength. Ad- tion to orthopaedic surgeons and the pa- eff Inc. are part of the DePuy Family of vanced screw technologies in the system tients they treat.” Companies of Johnson & Johnson, which offer surgeons the ability in select plates The modular design of the RECLAIM has a rich heritage of pioneering a broad to choose from up to five different screw Revision Hip System features novel instru- range of products and solutions across the options for the locking holes. ment technology that may improve in- continuum of orthopaedic and neurologi- The AFFIXUS Hip Fracture System offers traoperative handling, flexibility, and effi- cal care. These companies are unified un- an extensive range of neck and shaft ciency. The modularity of the system offers der one vision – Never Stop Moving – to angles, distal diameters, nail lengths and surgeons numerous options to treat a pa- express their commitment to bring mean- locking options to help surgeons bet- tient’s unique pathology while simplifying ingful innovation, shared knowledge and ter customize procedures to address the the instrumentation required in surgery. a caring touch to patients throughout the variations in individual patient anatomy. “The RECLAIM Hip System truly delivers world. The system, which is used with a single set a superb level of functionality and repro- Synthes is a leading global medical- of user-friendly instruments, combines the ducibility for surgeons performing revision device company specialized in the devel- principles of a compression hip screw with hip surgery,” says David Floyd, worldwide opment, manufacturing and marketing the biomechanical advantages of an in- president, DePuy Orthopaedics. “We be- of instruments, implants and biomaterials tramedullary nail. lieve that the RECLAIM Hip Stem, in con- for the surgical fixation, correction and re- GLOBAL ADVANTAGE+ is a new set junction with our PINNACLE Acetabular generation of the human skeleton and its of humeral preparation instruments de- Cup System, represents a meaningful ad- soft tissues. signed for ease of use and to enhance vance in revision hip surgery.” On March 28, 2011, DePuy Orthopae- versatility, speed and precision in shoul- The performance of a hip replacement dics, a global leader in devices for joint der replacement procedures. Instruments depends on a patient’s age, weight, ac- replacement and trauma, announced include new 1-mm increment humeral tivity level and other factors. There are 510(k) clearances from FDA for the A.L.P.S. reamers for a more precise implant fit, potential risks, and recovery takes time. Total Foot System and the AFFIXUS Hip a resection guide for greater accuracy, People with conditions limiting rehabil- Fracture Nail System. and a faster eccentric head trialing tech- itation should not have this surgery. Pa- The A.L.P.S. Total Foot System is a next- nique. GLOBAL CTA (cuff tear arthropa- tients should consult with an orthopedic generation system of anatomic plates de- thy) instrumentation is also being added surgeon to determine if hip replacement signed specifically for foot surgery. The to the core set of instruments. surgery is appropriate for them. AFFIXUS Nail System is a new set of short The performance of joint reconstruc- On Feb. 14, 2011, DePuy Orthopaedics and long nail and screw options and in- tive and joint replacement products de- received 510(k) clearance from FDA for strumentation for the treatment of prox- pends on a patient’s age, weight, activity the use of GRIPTION TF, a commercial- imal femoral fractures. Both systems are level and other factors. There are poten- ly pure titanium foam (TF), in two new im- designed to help surgeons accommo- tial risks, and recovery takes time. Peo- plant systems for complex joint replace- 25 ment procedures. The DePuy GRIPTION nent in patients with marked bone loss, Mentor Worldwide LLC TF Acetabular Augment System for hip providing surgeons with additional op- replacement surgery and the DePuy Uni- tions when faced with a complicated re- A subsidiary of J&J, Mentor Worldwide is versal GRIPTION TF Cones for knee-revision total knee replacement. The GRIP- the leader in the global aesthetic and placement surgery mark the first time the TION TF Cones, available in many sizes to reconstructive surgery marketplace. This company has offered implants made en- meet the needs of each individual pa- company is dedicated to developing, tirely from its proprietary GRIPTION TF tech- tient, are fully compatible with DePuy’s manufacturing and marketing science- nology. GRIPTION TF is a highly porous Sigma Knee System. based products for surgical and non-sur- structure made from commercially pure “DePuy’s GRIPTION TF System features gical medical procedures. titanium; a strong, corrosion-resistant met- several unique advances to create cus- Reinforcing its commitment to the aes- al that has high surface roughness and a tomized intraoperative solutions for pa- thetic medical market, Mentor Worldwide similar elasticity to bone. tients who require complex revision sur- introduced PDS Flexible Plate – the ab- The GRIPTION TF Acetabular Augment gery,” Mr. Floyd stated. “With DePuy’s sorbable implant that provides structural System fills the gap between the acetab- GRIPTION TF technology, surgeons will be support and streamlines cartilage man- ular bone and cup in patients with severe able to more confidently address even agement during nasal reconstruction pro- bone defects. The GRIPTION TF Acetab- the most challenging defects in conjunc- cedures – on Nov. 11, 2010. ular Augment System provides advanc- tion with our Pinnacle Acetabular Cup Nasal reconstruction surgeries, such es in fixation, materials and instrumenta- System.” as rhinoplasty and septoplasty, can be tion, all of which are critical to achieving The performance of a hip or knee re- difficult and time consuming – requiring successful patient outcomes. The com- placement depends on a patient’s age, the meticulous reconnecting of cartilage ponents of the system are engineered to weight, activity level and other factors. pieces to form a straight, solid plate that provide a wide range of options and con- There are potential risks, and recovery bridges and supports nasal structures. figurations so that each patient’s implant takes time. People with conditions limit- These procedures frequently result in dis- components can be customized at the ing rehabilitation should not have this sur- posal of valuable cartilage and compli- time of surgery. gery. Patients should consult with an or- cations requiring re-operation and sec- The DePuy Universal GRIPTION TF Cones thopaedic surgeon to determine if hip or ondary surgeries. PDS Flexible Plate is a for knee-replacement surgery can be knee replacement surgery is appropriate biodegradable polydioxanone surgical used with the tibial or femoral compo- for them. material that can act as a scaffold for the

Johnson & Johnson

Source: J&J

26 assembly of the cartilage pieces and sup- by surgeons for more than 20 years. PDS cause they are less likely to be felt through port newly reconstructed cartilage during Flexible Plate is manufactured by Ethicon the skin and tissue. the critical healing period following sur- and distributed by Mentor. Mentor’s Contour Profile Expander is gery. It can also reduce the need for sec- PDS Flexible Plate is the first surgical fa- designed to expand primarily in the low- ondary cartilage donor site surgery. cial aesthetics product offering from Men- er portion of the breast, so the resulting “The introduction of PDS Flexible Plate tor. “Mentor’s partnership with Ethicon Inc. pocket will accommodate the implant will provide surgeons with a new surgical further enhances our ability to provide sur- and slope like a mature breast. Con- tool that delivers an absorbable, struc- geons and patients with the trusted, clin- tour Profile also has an integral “injection tural support they may use for nasal re- ically proven products that they have dome” that allows surgeons to add sa- construction,” said Jack P. Gunter, M.D., come to expect from both companies,” line solution to the expander and grad- of Dallas-based Gunter Center for Aes- states Martin Weisberg, M.D., director of ually stretch the breast tissue over sever- thetics & Cosmetic Surgery. “PDS Flexi- medical affairs, Ethicon. al months. ble Plate can provide surgeons with a use- Mentor’s MemoryGel and Saline-filled MemoryGel Implant Sizers and Resteril- ful, versatile surgical option that may lead Breast Implants are indicated for breast izable Gel Breast Implant Sizers are used to to lower incidence of suboptimal cosmet- augmentation in women (at least 22 years determine breast implant size and shape ic and/or functional outcomes.” old for MemoryGel Implants and 18 years for temporary intraoperative use. MENTOR Multiple clinical study results found pa- old for Saline) or for breast reconstruction. Gel Sizers are precision-made to be com- tients who underwent surgery with PDS After decades of research and testing, patible with the company’s entire Memo- Flexible Plate had few immediate and MemoryGel Breast Implants were FDA-ap- ryGel Implants family of products. no long-term complications, and report- proved for women in the United States in Through an alliance with MTF, the ed revision rates were low. 2006 – an important advancement in the world’s largest tissue bank, Mentor of- Nasal reconstruction surgeries require a field of breast augmentation. fers FlexHD Dermis. This acellular dermal versatile surgical tool that can be adapt- Each implant is filled with Mentor’s co- matrix is derived from donated human al- ed to meet various clinical needs. PDS hesive gel that holds together uniform- lograft skin. FlexHD is a registered trade- Flexible Plate meets the unique demands ly and retains a natural give that better mark of the Musculoskeletal Transplant of surgeons who perform these proce- resembles breast tissue. Mentor’s superi- Foundation. dures. PDS Flexible Plate remains intact or saline-filled breast implants come in a Siltex is a textured surface breast im- during the critical healing process of the variety of shapes, sizes, profiles and sur- plant, and preferred by some physicians, first 10 weeks after implantation but is ab- face textures. They are filled with a salt- smooth-surface breast implants may be sorbed completely within 25 weeks, leav- water solution that is very similar to the chosen because they are less likely to be ing no residue and minimal fibrous scar tis- fluid that makes up most of the human felt through the skin and tissue. sue. This absorbability avoids some of the body. Saline implants are inserted into the Spectrum Breast Implants, the saline- long-term problems associated with non- body without fluid, and then filled during filled post operatively adjustable breast absorbable implants. surgery through a fill-tube to the desired implant style, is exclusive to Mentor World- Clinical studies show; PDS Flexible Plate size. When the fill-tube is removed, the im- wide. The product’s design allows phy- provides non-warping support during plant automatically seals itself. sicians to adjust the size of the breast healing. PDS Flexible Plate supports the These implants are filled with a saltwa- implant for up to six months after breast- graft pieces as a guide, bridging and sup- ter solution similar to the fluid that makes augmentation surgery. In a simple office porting the nasal structure and prevent- up most of the human body Saline im- procedure, surgeons can add or remove ing overlap and bending. Patients who plants have a slightly firmer feel than saline to adjust the final size of the breast have undergone multiple nasal surgeries gel-filled implants They have a flexible implant. risk graft depletion. PDS Flexible Plate of- fill volume that can be adjusted by the The Spectrum Implants is a technolog- fers a highly versatile and reliable way of surgeon during the procedure. Patients ically innovative design that allows sur- making maximal use of many cartilage can choose from three projection options: geons to make adjustments post opera- fragments otherwise discarded, and may Moderate, Moderate Plus and High Pro- tively. A small, removable fill tube is left reduce the need for secondary cartilage file; and two shell-surface options: smooth temporarily attached to the breast im- donor site surgery. and textured. plant after surgery. The tube is accessible PDS Flexible Plate is available in a num- Round saline breast implants are the to the physician by injection through the ber of sizes and configurations, one of most popular saline breast implant choice skin. In a simple office procedure, breast- which is perforated. The product can be for breast augmentation and breast re- implant size can be varied until the de- trimmed to suit a variety of anatomical construction. Round breast implant sired effect is achieved. At this point, the conditions and surgical needs including shapes are available in a wide array of siz- fill tube is removed (again, in a routine of- rhinoplasty and septoplasty procedures. es to accommodate various body types. fice visit) and a self-sealing valve imme- The temporary scaffold can be used to They also come in a High Profile style for diately closes and seals the breast im- construct columellar struts, septal exten- greater projection in the breast profile. plant. sion grafts, alar battens, and upper-later- Round breast implant shells come in two Used in breast reconstruction, Mentor’s al replacement grafts. textures; Smooth or Siltex Implant. Siltex Contour Profile Expander is designed to PDS polymer was invented by J&J’s is a textured surface breast implant, and expand primarily in the lower portion of Ethicon Inc., a worldwide leader in surgi- preferred by some physicians, smooth sur- the breast, so the resulting pocket will ac- cal care, and has been used and trusted face breast implants may be chosen be- commodate the implant and slope like 27 a mature breast. It also has an integral LEGION Knee System delivered strong technology is used in both hip and knee “injection dome” that allows surgeons to growth. This was driven by FDA clearance replacement implants. add saline solution to the expander and to claim that VERILAST bearing technolo- The Australian Orthopaedic Associ- gradually stretch the breast tissue over gy for knee replacement provides wear ation’s National Joint Replacement Reg- several months. performance sufficient for 30 years of ac- istry Annual Report tracks virtually all joint tual use under typical conditions and by replacements implanted in that country. Smith & Nephew Plc. its VISIONAIRE Patient Matched Instrumen- In the 2010 edition, the group reported on tation sets. In the company’s hip franchise more than 150,000 hip replacements im- Smith & Nephew is a global medical-tech- both its traditional and new products planted between the years of 1999 and nology business with global leadership have continued to perform well, led by 2009. positions in orthopedics; including recon- its R3 Acetabular System. Sales of the BIR- The data shows that implants using ce- struction, trauma and clinical therapies; MINGHAM HIP Resurfacing System have ramicized metal technology, such as OX- endoscopy; including sports medicine; been weaker, but company officials are INIUM Oxidized Zirconium, in combination and advanced wound management. confident that the program of reinforcing with polyethylene, remained successful in Smith & Nephew is a global leader in ar- the superior clinical data with surgeons 97.9% of patients five years after surgery. throscopy and advanced wound man- and patients will be effective. Implants with bearings made from other agement and is one of the leading glob- During 2011, Smith & Nephew repre- materials had to be revised (surgically coral orthopedics companies. sentatives expect the company’s Ortho- rected or replaced) during the same peri- Smith & Nephew is dedicated to help- paedic Reconstruction segment to grow od at higher rates. The survivorship rate for ing improve people’s lives. The company at above the market rate, as the momen- ceramicized metal bearings improved to prides itself on the strength of its relation- tum in its knee franchise looks set to con- 98.5% in the larger component sizes, and ships with its surgeons and profession- tinue. the performance gap between cerami- al healthcare customers, with whom the On Dec. 2, 2010, a newly released pa- cized metal bearings and other bearing company name is synonymous with high tient registry reported that hip-replace- materials widened as well. standards of performance, innovation ment implants made from ceramicized “OXINIUM material in combination and trust. Smith & Nephew has distribution metal heads that articulate against poly- with cross-linked polyethylene is unique channels, purchasing agents and buying ethylene-lined cups have been shown to among hip replacement technologies,” entities in more than 90 countries world- have superior survivorship compared with says Joseph M. DeVivo, president of Smith wide. Smith & Nephew recorded $4 billion implants made from any other material & Nephew Orthopaedics. “We’re thrilled in annual sales in 2010. five years after surgery. OXINIUM Oxidized by these results – we’ve worked hard to In fourth-quarter 2010, the compa- Zirconium and cross-linked polyethylene introduce technologies that improve the ny reported that its market-leading knee (XLPE), the materials in VERILAST technol- wear performance of implants, and this performance was driven by the FDA-ap- ogy from Smith & Nephew’s Orthopaedics report confirms our decades of research proved 30-year wear claim for its VER- Division, comprise the overwhelming ma- and innovation. Active patients demand ILAST bearing technology for knee re- jority of ceramicized metal hip implants in implants that can keep pace with their placement and its VISIONAIRE Patient the global orthopedic market. VERILAST lifestyle, and we have the patent on the Matched Instrumentation sets. Smith & Nephew is continuing its successful mar- Smith & Nephew keting programs and increasing instrument set availability outside of the Unit- ed States. In hips, the company is reinforcing the strong clinical data for BIRMINGHAM HIP Resurfacing System and refining its marketing programs. The benefits of using VE- RILAST bearing surface in hips has been reinforced by the recent Australian Regis- try data which, for the first time, provided separate, positive data for ceramicized hip bearing surfaces. Smith & Nephew’s Orthopaedic Re- construction segment full-year 2010 performance was marked in particular by the economic environment and the strength of its knee franchise. There has continued to be pressure from the challenging environment on higher specification and early intervention hip and knee implant systems. Nevertheless, the company’s knee Source: Smith & Nephew franchise outperformed the market as its 28 most technologically advanced materi- Division shared the results of unprecedent- surgery are in its risk of infection and bone al for this segment.” ed testing on its VERILAST technology for loss for the patient and the procedure’s Studying the performance of OXINIUM knee-replacement implants. After simu- cost for the healthcare system. Oxidized Zirconium against other bearing lating 30 years of physical activity on the “If we’re successful in our drive to make surfaces in a large patient group is now company’s LEGION knee replacement, knee replacements that last a lifetime, possible because the 2010 edition of the VERILAST technology produced an 81% that could mean significant cost savings patient registry marks the first time the reduction in wear, the leading cause of to the healthcare system,” Mr. DeVivo Australian Orthopaedic Association has knee-replacement failure. says. “And patients may avoid the pain tracked “Ceramicized Metal/Polyethyl- FDA reviewed the results and Smith and the downtime associated with revi- ene” as a distinct category of bearing- & Nephew received 510k clearance for sion surgery.” surface materials. OXINIUM material is a claims related to VERILAST technology’s Smith & Nephew’s primary knee re- metal alloy that undergoes a proprietary ability to “provide wear performance placement systems, the LEGION and GEN- heating process, transforming its surface sufficient for 30 years of actual use under ESIS II knee implants, are available with into a hard, smooth ceramic that is 4,900 typical conditions.” The consensus of sci- VERILAST technology. The ANTHOLOGY times more resistant to scratching than entific literature is that knee implants are Hip System is an evolution on past clini- the traditionally used metal alloy, cobalt expected to last 10-to-15 years. cally successful flat taper stems. Both in- chrome. “Physically active patients want to struments and implants were designed to The underlying alloy retains its original end their knee pain for good,” Mr. DeVi- help improve surgical efficiency and out- properties, giving the implant the strength vo stated. “We’re working to make knee comes. of metal, but the improved wear perfor- implants that last a lifetime – that’s our Not every surgical approach is the mance of a ceramic. The material is 20% goal, and we’ve validated VERILAST tech- same, so not all instrumentation should lighter than cobalt chrome, does not con- nology out to 30 years for a market that be the same. The ANTHOLOGY system is tain detectable amounts of nickel like co- views 10 to 15 years as the gold standard. the first femoral implant to have integrat- balt chrome does, and is considered hy- This is not an incremental improvement; ed instruments designed for specific min- poallergenic and safe for patients with it’s a generational leap forward for ac- imally invasive surgical approaches. metal allergies. tive patients.” With optimal stem geometry and the Smith & Nephew recently introduced “Every orthopaedic device company widest range of sizes, the ANTHOLOGY sys- VERILAST Technology, which is the combi- has focused for years, if not decades, on tem offers the ability to match all femur nation of OXINIUM material and a unique developing the best possible bearing sur- types. In combination with Smith & Neph- cross-linked polyethylene formula. This faces for improving the performance and ew’s proven neck design and Advanced bearing couple has been shown in lab- longevity of knee implants,” reports Scott Bearing portfolio, the surgeon has the abil- oratory tests to reduce hip-implant wear Elliott, senior VP and general manager, ity to restore the patient’s biomechanics by up to 98% when compared with co- global knee franchise, Smith & Nephew and natural range of motion. balt chrome and conventional polyeth- Orthopaedics. “To reduce wear in knee The innovative JOURNEY DEUCE Bi- ylene. replacements, companies have all creat- Compartmental Knee System is a rev- In April 2010, Smith & Nephew an- ed their own formulas for the dense plas- olutionary concept where the medial nounced the results of an unprecedent- tic component (highly cross-linked poly- tibiofemoral compartment and patel- ed laboratory test on the use of VERILAST ethylene, or XLPE) used on the tibial side lofemoral compartment are replaced Technology with its LEGION Primary Knee of a knee implant. And all companies, in- with a single femoral component. The System, which is expected to provide per- cluding Smith & Nephew, have reported JOURNEY DEUCE System is the first knee formance for 30 years of typical physical progress on this front. But there are two system to successfully retain ACL and PCL activity. bearing surfaces in a knee, and only one function, allowing more normal kinemat- The results of this in-vitro wear simu- company has been successful in improv- ics and proprioception throughout the lation testing have not been proven to ing the other side of the joint – the metal range of motion. quantitatively predict clinical-wear per- femoral component.” The JOURNEY DEUCE Bi-Compartmen- formance. Also, a reduction in total poly- Smith & Nephew is the only compa- tal Knee System accommodates deep ethylene wear volume or wear rate alone ny in the world to commercialize an ad- flexion, enables normal tibiofemoral ax- may not result in an improved clinical out- vanced bearing surface for the femoral ial rotation and provides patellar track- come as wear particle size and morphol- component of a knee replacement. OX- ing throughout the entire range of flex- ogy are also critical factors in the evalu- INIUM oxidized zirconium is a proprietary ion while retaining the healthy lateral ation of the potential for wear mediated material that has been used in more than tibiofemoral compartment. osteolysis and associated aseptic implant 200,000 knee procedures and is proven to The JOURNEY DEUCE instruments were loosening. Particle size and morphology reduce wear. designed to work well using an MIS ap- were not evaluated as part of the testing. Typically, if a knee replacement fails proach. The instruments were based on The same test has not been performed on due to wear, the patient will undergo a proven concepts while maximizing stabili- the use of VERILAST technology in hip re- “revision” surgery in which the original ty and accuracy. The instruments are sim- placements. components will be replaced with more ilar to traditional MIS TKA instruments so As evidence of its drive to return knee invasive, more expensive ones. Although that surgeons would feel comfortable us- pain sufferers to a lifetime of physical ac- there may be some decrease in implant ing them for the first time. Using the latest tivity, the Smith & Nephew Orthopaedics performance, the primary costs of revision in wear-reducing material technology – 29 OXINIUM Oxidized Zirconium – the JOUR- with the “30 Year Knee,” which may re- The company’s Contour Meniscus NEY DEUCE knee system also addresses sult in a longer lasting implant. Arrow implant is indicated for the repair the issue of implant longevity. By design- The Triathlon Knee System represents of vertical, longitudinal “Bucket-Han- ing a knee system that retains normal the contribution of more than 30 years of dle” tears of the meniscus in the vascular knee function and overcomes limitations clinical success in orthopedic implants. zone (red-red-white) through arthroscop- of conventional systems while maintain- The Triathlon Knee is designed for natural ic and open methods. The Contour Me- ing excellent durability and robustness, knee movement, helping to relieve pain niscus Arrow implant features a low-pro- Smith & Nephew has created a true ac- and restore independence. The Triathlon file contoured head, which sinks into the tive knee system that redefines success in Knee System is designed to allow for nat- meniscus while compressing the tear. The conventional knee arthroplasty. ural knee motion and up to 150° of flex- device is barbed along the entire length ion. of the implant shaft for superior fixation Stryker Corp. strength. ConMed Corp. The Contour Meniscus Arrow implants Stryker is one of the world’s leading med- are made of a new proprietary Self-Rein- ical-technology companies with among ConMed is a medical-technology com- forced copolymer, 80L/20D,L PLA, which the most broadly based range of prod- pany with an emphasis on surgical de- imparts to the implants an ultra-high ucts in orthopedics and a significant pres- vices and equipment for minimally inva- strength microstructure that has a unique ence in other medical specialties. Ac- sive procedures and patient monitoring. ability to resist shear and torque while the cording to the company, Stryker works The company’s products serve the clini- tear is healing. The new 80L/20D,L PLA co- with respected medical professionals to cal areas of arthroscopy, powered surgi- polymer is a faster-resorbing implant ma- help people lead more active and more cal instruments, electrosurgery, cardiac terial that will continue to provide strength satisfying lives. monitoring disposables, endosurgery and for up to 24 weeks while the tear is remod- Stryker is a leader in the worldwide or- endoscopic technologies. The products eling and then gradually resorb away. thopedic market and is one of the world’s are used by surgeons and physicians in a On Nov 17, 2009, ConMed Corp.’s largest medical-device companies. Stryk- variety of specialties including orthope- ConMed Linvatec arthroscopy unit an- er delivers results through a wide range dics, general surgery, gynecology, neuro- nounced the release of new sizes of its of capabilities including joint replace- surgery and gastroenterology. With head- Matryx Biocomposite Interference Screw. ments, trauma, spine and micro implant quarters in Utica, N.Y., ConMed’s 3,200 These new screws represent the latest ad- systems, orthobiologics, powered surgi- employees distribute its products world- vance in biocomposite material tech- cal instruments, surgical navigation sys- wide from several manufacturing loca- nology that allows ConMed Linvatec to tems, endoscopic products as well as tions. produce the smallest Biocomposite Inter- patient handling and emergency medi- About 60% of the company’s revenue ference screw available on the market cal equipment. Stryker also provides out- is derived from products designed for the for primary fixation of ACL and PCL grafts. patient physical therapy services in the orthopedic surgery markets of arthrosco- The company introduced the product at United States. py and powered surgical instruments. the Fall Arthroscopy Association of North As a global leader in the development ConMed additionally sells products for America (AANA) meeting in Palm Springs, of orthopedic products and services, Stryk- general and other surgical specialties Calif, during November 2009. er is committed to researching and de- such as electrosurgery systems for all Matryx interference screws are indicat- veloping new ways to address people’s types of surgery, and endosurgery instru- ed for soft-tissue fixation in ACL and PCL needs – including introducing new materi- ments for minimally invasive laparoscop- reconstructions. With the new smaller sizes, als that make replacement joints feel and ic surgery. Patient-care products, includ- in conjunction with the new Bullseye An- act more like the natural joint. ing ECG electrodes for heart monitoring atomic Cruciate Reconstruction System, Many things including patient weight, and pulse oximetry for blood oxygenation ConMed Linvatec can provide a com- activity level as well as the implant’s monitoring, are provided for various clin- plete anatomic solution for cruciate re- bearing surface technology can affect ical settings. pairs. The new smaller Matryx screws are the longevity of the implant. The bear- About 75% of the company’s revenue used extensively in double-bundle ana- ing surface is defined as the two parts is derived from the sale of single-use prod- tomic reconstructions where two small of the knee that glide together through- ucts. Capital equipment such as powered bone tunnels are drilled for the recon- out motion. Stryker’s advanced bearing drills and saws for surgery, electrosurgical struction of the ligament. The existing technology, called X3, has demonstrat- generators, video-imaging cameras, fluid larger Matryx sizes (7-11mm) are indicated a 96% decrease in wear in laboratory control systems, and surgical hand-pieces ed for soft-tissue and BTB graft fixation in testing compared with competitive pre- are marketed to facilitate the sale of dis- ACL and PCL reconstructions. mium bearing technology. Based on this posable products. Additionally, ConMed “The important advances we have testing, X3 Technology may result in a lon- provides integrated operating room in- made in biomaterials technology have ger-lasting implant. This new technology tegration for the most modern operat- enabled us to be first to market with one is particularly important for younger pa- ing room facilities. ConMed distributes of the smallest available Biocomposite in- tients. its products globally through its own U.S. terference screws for primary fixation in Based on laboratory testing, Stryker’s sales network, international direct market- ACL and PCL reconstructions,” reports Triathlon Knee with X3 technology has a ing in nine countries, and specialty distrib- Joseph Darling, president of ConMed 24% lower wear rate when compared utors in other countries. Linvatec. “We continue to leverage our 30 extensive expertise in biomaterials to de- implant maintains accurate alignment of with a more forgiving track, which allows liver a broad range of customer solu- small bone fractures and apex fragments, the knee to achieve motion without sac- tions. In conjunction with the previously osteochondral fragments, and cancel- rificing healthy bone during surgery. announced Bullseye Anatomic Cruciate lous/non-loadbearing fragments after an Additionally, some manufacturers pro- System, we now offer a complete system arthroscopy or open surgery. mote that the angle at which the knee- of products for anatomic cruciate recon- The XO Button is an implant for extra- cap moves against the thighbone is high- structions which should further enhance cortical, soft-tissue fixation in cruciate re- er in women. However, one study actually our market position.” constructions. The continuous loop is tight- indicates that a person’s height has a ConMed Linvatec is a global leader in ly woven and pre-stretched to remove greater affect on the tracking angle than the fields of arthroscopy, multi-specialty creep before implantation. Combined his or her gender, according to Biomet endoscopic medical video systems and with a simplified surgical technique, the officials. The Vanguard Knee is designed powered surgical instruments. With head- XO Button implant provides strength and with a unique kneecap track that allows quarters in Largo, Fla., ConMed Linvatec is security for all ACL and PCL reconstruc- the knee implant to match nearly any pa- at the forefront of technology for a grow- tions. tient regardless of gender or stature. ing range of minimally invasive and ortho- The Vanguard Complete Knee is engi- paedic surgery procedures. Biomet Inc. neered to accommodate up to 145 de- Orthopedic surgeons use ConMed Lin- grees of flexion without the need to re- vatec arthroscopic instrumentation, im- Biomet and its subsidiaries design, man- move additional healthy bone. A high plants, fixation and tissue-repair systems ufacture, and market products used pri- degree of flexion is an important consid- with brand names that include Linvatec marily by musculoskeletal medical spe- eration for any person desiring to continue and Shutt for diagnostic purposes, minor cialists in both surgical and non-surgical leading an active, productive lifestyle. surgeries and complex reconstructions of therapy. Biomet’s product portfolio en- The Vanguard system offers the broad- knees, shoulders and small joints such as compasses reconstructive products, in- est range of available implant sizes. This is the wrist and ankle. cluding orthopedic joint replacement important because implants that are too Interference screw fixation is frequent- devices, bone cements and accesso- wide can hang over the bone and irri- ly used to attach replacement ligaments ries, autologous therapies and dental re- tate the soft tissues in the knee. When the in tunnels drilled for anterior and posteri- constructive implants; fixation products, Vanguard Knee was introduced in 2003, or cruciate ligament reconstruction. The including electrical bone growth stimu- the device was the narrowest knee on the placement of the screw in the boney tun- lators, internal and external orthopedic market, providing a more natural feeling nel with the ligament results in compres- fixation devices, craniomaxillofacial im- implant. The Vanguard Knee features 90 sion of the ligament against the boney plants and bone substitute materials; spi- different size combinations and 10 femo- surface of the tunnel. Such compression nal products, including spinal stimulation ral size options, more than any other knee allows the tissue to be held in place and devices, spinal hardware and orthobio- replacement system. provides for the integration of the replace- logics; and other products, such as ar- With more size options than other im- ment ligament with the bone via natural throscopy products and softgoods and plant manufacturers, surgeons can pro- healing pathways. The Matryx biocom- bracing products. With headquarters in vide more of a custom fit to patients’ posite screw encourages bone formation Warsaw, Ind., Biomet and its subsidiaries bones. Additionally, any size femoral im- due to the presence of the bone pre-cur- currently distribute products in about 90 plant is engineered to fit with any size tib- sor Beta TriCalcium Phosphate, resulting in countries. ial implant. This provides more size op- strong bone reconstruction and integra- When considering knee-implant de- tions than other implant manufacturers, tion of the replacement ligament. sign, how the kneecap moves against the which allows surgeons to provide more The EndoPearl fixation device is a pro- new femoral component is very impor- of a custom fit of each Vanguard femo- prietary, unique device indicated for use tant. Knee implants are designed with a ral and tibial implant to patients’ bones, in conjunction with a Linvatec BioScrew groove, or track, that the kneecap rides in addressing the largest possible percent- Interference Screw to provide enhanced as the leg straightens and bends. How this age of the population. fixation of soft-tissue grafts within the fem- track is designed is important because it Polyethylene (plastic) is used to re- oral socket during ACL reconstruction. partially determines how mobile the knee place the damaged cartilage at the top Made of Poly (L-Lactic Acid), the implant is and, to a certain extent, the level of of the tibia. The polyethylene acts to ab- is gradually absorbed and eventually dis- comfort the implant provides. sorb the stress of everyday activities. The appears. Simple method of preparing im- Currently, some implant companies Vanguard Complete Knee System’s poly- plant and graft construct. are marketing orthopedic knee replace- ethylene components are Direct Com- Linvatec’s SmartNail 2.4mm implant ments designed specifically for women, pression Molded to help increase the im- is a bioresorbable bone fixation nail in- but Biomet scientists believe that implants plant’s longevity. The process of direct tended for use in the fixation of fracture should be designed to accommodate compression molding has been shown to fragments resulting from trauma or osteo- any individual’s anatomy regardless of produce more durable implant compo- chondritis dissecans lesions. The Self-Rein- race, stature, or gender. nents than other conventional methods. forced manufacturing process preserves Biomet’s Vanguard Complete is the The Oxford Partial Knee implant from high initial mechanical strength and stiff- most comprehensive total knee system Biomet Orthopedics is a partial knee ness of the implants. In the presence of available, according to the company. implant designed to repair only one side adequate immobilization, the SmartNail The Vanguard Knee implant was designed of the knee (the medial side), making it 31 much smaller than a total knee implant. ditional stem design options for better im- professionals around the world. BIOMET 3i In patients with only limited knee arthri- plant-to-bone match. This may help the is based in Palm Beach Gardens, Fla., with tis, known as medial compartment arthri- implant last longer and reduce the poten- operations throughout North America, Lat- tis, surgeons may elect to perform a partial for painful implant loosening. in America, Europe and Asia-Pacific. tial knee replacement. Unlike total knee A patient who is a potential candidate BIOMET 3i offers one of the most com- replacement that removes all the knee for reverse shoulder replacement may be prehensive lines of dental implants and joint surfaces, a partial knee replacement suffering from pain as a result of a previ- dental-implant abutments, augment- replaces only one side of the knee joint. ous rotator cuff tear. A cuff tear causes ed by a growing line of site-preparation Some advantages of the Oxford partial the shoulder joint to lose much of its nat- and regenerative products. BIOMET 3i pi- knee replacement are that the device re- ural support, leading to increased instabil- oneered the development of biologically moves 75% less bone and cartilage, is less ity. Often, this results in the normal shoul- driven dental implants, gaining global ac- painful, enables a more rapid recovery, der becoming destabilized and moving claim for the microtextured surface and and provides more natural motion when out of socket completely. Over time, this superior clinical success rates of the OS- compared to a total knee replacement. instability leads to bone-on-bone contact, SEOTITE Dental Implants. By retaining all of the undamaged parts, moderate-to-severe pain, and extremely On Feb. 28, 2011, building on the suc- the joint may bend and function more limited mobility. cess of the Navigator System for Paral- naturally. Reverse shoulder replacement has rev- lel Walled Implants, BIOMET 3i introduced Knee osteoarthritis usually occurs first olutionized the treatment of massive rota- the Navigator System for Tapered BIOM- in the medial portion of the joint. In knees tor cuff tears. The unique procedure re- ET 3i Implants. The Tapered Navigator Sys- that are otherwise healthy, a partial knee verses the anatomy of the shoulder. The tem offers the only guided surgery instru- implant procedure can preserve the procedure is designed so that the ball is mentation designed to provide clinicians healthy bone, cartilage, and ligaments, attached to the scapula and the socket with four levels of guided control for ac- potentially preventing or delaying the is placed on top of the humerus. By revers- curate tapered implant treatment, includ- need for total knee replacement. ing the normal anatomy, the deltoid mus- ing control of implant angulation, hex ori- Unlike other implants, the Oxford Partial cle – one of the stronger shoulder muscles entation, depth and position. The BIOMET knee is currently the only fully mobile bear- and the only abducting muscle remain- 3i Tapered Navigator System for Guided ing partial knee system available in the ing in the shoulder – is given control to Surgery was developed in response to cli- United States. Research has shown that raise the arm. nicians’ growing interest in using the ben- partial knee replacements with move- The Comprehensive Reverse Shoul- efits of Computed Tomography (CT) for able plastic bearings like the Oxford Par- der implant from Biomet offers surgeons dental-implant placement and the desire tial knee have low wear rates, potentially many options for restoring function and to accelerate patient provisionalization. giving them even longer life expectan- reducing pain. The shoulder system is a CT guidance technology allows clini- cies. The free-floating nature of the de- next-generation reverse shoulder prosthe- cians to determine the locations of an- vice potentially provides for a more nat- sis, offering unmatched surgical flexibili- atomical structures and the dimensions ural feeling knee. ty for orthopedic surgeons. Most candi- of underlying bone as well as to ascer- In a healthy knee, the meniscus serves dates for reverse shoulder replacement tain bone densities in order to plan and as a shock absorber between the ends of are in extreme pain, have almost no perform cases. The Tapered Navigator the bones. The Oxford Partial knee is the shoulder mobility and have tried various System offers a guided solution from the first partial implant with an artificial me- treatment options, oftentimes including treatment plan to tapered implant place- niscal bearing designed to glide freely primary shoulder replacement. Reverse ment to provisionalization; depth and di- throughout the knee’s range of motion, shoulder replacement is intended to al- ameter-specific instrumentation for pre- more closely replicating normal move- leviate pain and improve mobility to the cise osteotomy preparation and tapered ment. point of being able to perform activities implant placement; and accuracy of pre- Published long-term clinical results on of daily living (ADLs). planning and tapered implant placement the Oxford Knee demonstrated a 98% The goals of reverse shoulder replace- that provides the option of minimally in- success rate at 10 years and 95% at 15 ment are pain relief as well as improved vasive surgery and immediate provision- years and beyond, equaling the results function. alization. of the most successful total knee replace- On March 22, 2011, BIOMET 3i and ments. BIOMET 3i 3Shape A/S entered into a collabora- The Taperloc Hip System from Biom- tive relationship to provide dental labo- et has led the competition in design and BIOMET 3i, a division of Biomet Inc., is a ratories with the ability to design patient- longevity for more than 20 years. Joint re- leading manufacturer of dental implants, specific abutments through the use of placement implants are not one-size fits abutments and related products. Since its 3Shape Dental 3D Scanners, DentalDe- all. The Taperloc Hip System offers three inception in 1987, BIOMET 3i has been on signer, AbutmentDesigner CAD Software stem options to properly address an indi- the forefront in developing, manufacturing and Computer-aided Manufacturing. vidual femoral canal: Taperloc Hip Stem; and distributing oral reconstructive prod- BIOMET 3i will expand the digital den- Taperloc Reduced Distal Stem; and Taper- ucts, including dental implant components tistry product offering through 3Shape loc Microplasty Stem. and bone and tissue-regenerative mate- with 3i incise Copings and Frameworks in Unlike other hip stems of its type, the Ta- rials. The company also provides educa- Zirconia and Cobalt Chrome. The copings perloc Hip is the only system to offer ad- tional programs and seminars for dental and frameworks may be milled at BIOMET 32 3i and Renishaw’s central manufacturing Warsaw, Ind., Zimmer designs, develops, ylene system demonstrated 83% wear re- sites or locally using a Renishaw Mill. This manufactures and markets orthopedic duction compared to conventional poly- collaboration solidifies the BIOMET 3i com- reconstructive, spinal and trauma devic- ethylene. Zimmer was the first company to mitment to continue its effort in driving the es, dental implants, and related surgical launch XLPE more than nine years ago for best aesthetic patient outcomes. products. Zimmer has operations in more the NexGen Fixed Bearing system. Since its This integrated approach allows dental than 25 countries around the world and launch, the blend specifically formulated laboratories to have control over implant sells products in 100-plus countries. Zimmer, for the knee has been used in more than abutment design and submit orders elec- which employs more than 8,800 people 450,000 implantations worldwide and has tronically to the BIOMET 3i Patient Specif- worldwide, reported sales of about $4.22 demonstrated 81% (CR) and 78% (PS) ic Products Department for the fabrica- billion in 2010. wear reduction compared with conven- tion of Lab-Designed Abutments. This new On Jan. 13, 2011, Zimmer Holdings tional poly during in vitro wear simulator process eliminates the need to physical- launched the Zimmer NexGen LPS-Flex testing. ly package and ship orders to BIOMET 3i Mobile Bearing Knee with Prolong High- On Dec. 21, 2010, Zimmer Holdings and reduces in-house processing time. ly Crosslinked Polyethylene (XLPE) in the completed the acquisition of Beijing 3Shape Scanners, available through BI- United States. The LPS-Flex Mobile Bear- Montagne Medical Device Co. Ltd. The OMET 3i and other suppliers, are used to ing knee provides a revolutionary anteri- acquisition further enhances Zimmer’s create accurate 3D scans of dies/stumps, orly positioned pivot near the entry point presence in the emerging Chinese mar- inlay preparations, bridge preparations, of the anterior cruciate ligament (ACL), ket. bites/antagonists, wax-ups and full den- replicating the anatomic center of knee “We are delighted to welcome Mon- tal casts. rotation. tagne to the Zimmer family,” states David Most recently, 3Shape has introduced The LPS-Flex Mobile system is backed C. Dvorak, president and CEO of Zimmer. the add-on module, AbutmentDesign- by more than 10 years of successful clini- “Our expansion in China demonstrates er. Existing 3Shape Scanner users will be cal history in Europe and Japan. Since the Zimmer’s commitment to invest globally able to obtain a trial version or purchase system’s launch, more than 130,000 LPS- in high-growth emerging markets.” the AbutmentDesigner upgrade direct- Flex Mobile knees have been implanted The acquisition will provide an expand- ly from their supplier. With the supplier’s worldwide. ed product line in hips, knees and pow- consent, the upgrade comes complete “Our Prolong Highly Crosslinked Poly- ered surgical instruments tailored to the with the BIOMET 3i Library consisting of im- ethylene provides a number of clinical Chinese market. “We want to create plants, scanning cap and abutment con- advantages, including reduced wear products that address the unique needs nection geometry, abutment screw and and delamination resistance,” says Jeff of the Chinese market. Montagne will pro- access hole images. McCaulley, president, reconstructive, vide us access to additional research, de- “We are excited to be collaborating Zimmer. “Applying this exciting material velopment, and manufacturing capabili- with a leader in the dental scanner mar- to our already successful NexGen LPS-Flex ties that will allow us to achieve this goal,” ket,” states Bryan D. Pinciaro, VP of global Mobile Bearing Knee System represents says Stephen Ooi, president, Asia Pacif- marketing for BIOMET 3i. “Users of 3Shape a major step forward in mobile bearing ic, Zimmer. Scanners will be able to receive abut- design.” On Dec. 13 2010, Zimmer Holdings’ Tra- ments made to the standards they expect During in vitro wear simulator testing, becular Metal Modular Cup received the from BIOMET 3i, now along with the add- the LPS-Flex Mobile with Prolong Polyeth- distinction of being awarded the highest ed advantage of a lab-chosen abutment design and reduced turnaround time at ZIMMER HOLDINGS a lower price point. This will enable us to deliver what we stand for: Providing Solu- tions – One Patient At A Time.” According to Rune Fisker, VP of product strategy for 3Shape, “We are pleased to be making our 3D scanner and abutment software technology available to customers in collaboration with one of the leading and most innovative dental implant companies in the industry. By developing this collaborative relationship with BIOM- ET 3i and their products, our users will get increased benefits. Our products are developed and manufactured to the highest standards making the 3Shape Dental System the solution of choice.”

Zimmer Holdings Inc. Source: Zimmer Holdings Founded in 1927 and with headquarters in 33 reimbursement premium percentage creased stress shielding and the material “The rapid success of our Cephalom- granted to date for an orthopedic prod- has the potential to improve long-term im- edullary Nail since its introduction earlier uct in Japan. plant fixation. this year is testament to its truly innovative The Japanese Central Social Insurance “We believe Trabecular Metal technol- design,” says Jeffrey Paulsen, president of Medical Council, otherwise known as the ogy represents one of the most significant Zimmer Global Businesses. “The nail en- Chuikyo, awarded Zimmer’s Trabecular material advancements in orthopaedics, ables surgeons to help restore the nat- Metal Modular Cup with an unprecedent- contributing both outstanding clinical ad- ural anatomies of patients of all shapes ed 20% reimbursement premium. The de- vantages and cost effectiveness to im- and sizes.” cision was presented by the Chuikyo ex- plants,” says Cheryl R. Blanchard, Ph.D., Both the long and short Cephalomed- pert panel after a comprehensive review senior VP and chief scientific officer, Zim- ullary Nails have anatomical bows that of both the material technology and clin- mer. “Securing this reimbursement and its help restore the shape of the femur to its ical data. The expert panel determined unprecedented premium level is a ma- natural, pre-injury state. The system uses that the extensive positive clinical data jor achievement for Zimmer. Japan is the Zimmer’s patented StabliZe Technology clearly demonstrated significant clinical world’s second largest orthopaedics mar- and optimized screw locations to help advantages and effectiveness of Zim- ket after the United States and we are ex- better link the nail to bone. Screws are mer’s proprietary Trabecular Metal Tech- cited to provide the unique advantages placed throughout the implant to further nology. Based on the review, a new func- of our Trabecular Metal technology to the secure the device and maintain length tional reimbursement category has been patients of Japan.” and alignment during the healing pro- established in Japan for the Trabecular On Oct. 13, 2010, Zimmer Holdings an- cess. These features help surgeons to Metal Modular Cup and was planned to nounced the one thousandth implanta- achieve stable fixation even in osteo- be introduced on Jan. 1, 2011. tion of its Zimmer Natural Nail Cepha- porotic bone. Color-coded instrumen- Trabecular Metal material is a high- lomedullary Nail in the United States since tation simplifies the process of matching ly porous biomaterial that resembles the the product’s release in April 2010. The nails with their corresponding guides. A structure, function, and physiology of Zimmer Natural Nail system features an wide range of widths, lengths and center- trabecular bone. No other porous met- innovative design focused on restoring column-diaphyseal (CCD) angles is avail- al material is supported by the amount patients’ original anatomy. able to match implants to the individual of peer-reviewed, published clinical data The Cephalomedullary Nail is designed anatomy of the patient. of Trabecular Metal Technology and its to help address fractures of the femur, Zimmer has initiated a prospective, history of proven success in orthopedic especially intertrochanteric and subtro- multi-center, post-market clinical study to applications. This novel material is con- chanteric fractures. The next-generation monitor and document the outcomes of ducive to bone formation, enabling ro- line of intramedullary nails, screws and patients receiving either the short or long bust biologic fixation and a stiffness simi- instruments are designed to provide sur- Cephalomedullary Nail in intertrochant- lar to cancellous bone. The properties of geons with an intuitive and easy-to-use eric and subtrochanteric proximal femo- Trabecular Metal Technology allow for de- system for long bone fixation. ral fractures.

34 Awaiting Approval: Implant-Related Rx Drugs and Biologics

Name Chemical Indication Drug Class Country Developer/Marketer Iluvien Fluocinolone Iluvien is intended for the Corticosteroid United States Developer/Marketer: acetonide treatment of diabetic Alimera Sciences Inc. and macular edema. pSivida Ltd. Iluvien Fluocinolone Iluvien is intended for the Corticosteroid European Union Developer/Marketer: acetonide treatment of diabetic Alimera Sciences Inc. and macular edema. pSivida Ltd. Implanon NXT Etonogestrel Implanon NXT is intended Contraceptives United States Merck & Co. for the prevention of pregnancy.

Phase III: Implant-Related Rx Drugs and Biologics

Name Chemical Indication Drug Class Country Developer/Marketer CollaRx Gentamicin CollaRx Gentamicin Aminoglycoside United States Developer: Innocoll Inc.; Gentamicin Surgical Implant is intended antibiotic Marketer: Baxter Healthcare Surgical Implant for the prevention of Corp. surgical site infections in patients who are at higher risk of infections. LCS — LCS is intended for Contraceptives European Union Bayer HealthCare prevention of pregnancy. Pharmaceuticals Octreotide Implant Octreotide Octreotide Implant is Synthetic peptide United States Endo Pharmaceuticals Inc. intended for the treatment of acromegaly. Octreotide Implant Octreotide Octreotide Implant is Synthetic peptide European Union Endo Pharmaceuticals Inc. intended for the treatment of acromegaly. Probuphine Buprenorphine Probuphine is intended for — United States Titan Pharmaceuticals Inc. and ethylene vinyl the treatment of opioid acetate dependence. Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte European Union Clinuvel Pharmaceuticals treatment of erythropoietic stimulating hormone Ltd. protoporphyria. Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte Australia Clinuvel Pharmaceuticals treatment of erythropoietic stimulating hormone Ltd. protoporphyria.

Phase II: Implant-Related Rx Drugs and Biologics

Name Chemical Indication Drug Class Country Developer/Marketer Bupivacaine Bupivacaine Bupivacaine Implant is — United States Innocoll Inc. Implant intended to provide pain control at the surgical site and thus reduce the level of additional analgesia required after surgery. Bupivacaine Bupivacaine Bupivacaine Implant is — European Union Innocoll Inc. Implant intended to provide pain control at the surgical site and thus reduce the level of additional analgesia required after surgery. Iluvien Fluocinolone Iluvien is intended for Corticosteroid United States Developer/Marketer: acetonide the treatment of dry Alimera Sciences Inc. and age-related macular pSivida Ltd. degeneration. Iluvien Fluocinolone Iluvien is intended for the Corticosteroid United States Developer/Marketer: acetonide treatment of retinal vein Alimera Sciences Inc. and occlusion. pSivida Ltd.

Source: eKnowledgeBase (eknowledgebase.com) 35 Phase II: Implant-Related Rx Drugs and Biologics

Name Chemical Indication Drug Class Country Developer/Marketer Iluvien Fluocinolone Iluvien is intended for Corticosteroid United States Developer/Marketer: acetonide the treatment of wet Alimera Sciences Inc. and age-related macular pSivida Ltd. degeneration. ITCA 650 Exenatide ITCA 650 is intended for Glucagon-like United States Intarcia Therapeutics Inc. the treatment of type 2 peptide-1 receptor diabetes. agonist NT-501 Ciliary neurotrophic NT-501 is intended for Ciliary neurotrophic United States Neurotech USA Inc. factor the treatment of retinitis factor pigmentosa. NT-501 Ciliary neurotrophic NT-501 is intended for Ciliary neurotrophic United States Neurotech USA Inc. factor the treatment of visual factor loss associated with the dry form of age related macular degeneration. Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte United States Clinuvel Pharmaceuticals treatment of erythropoietic stimulating hormone Ltd. protoporphyria. Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte United States Clinuvel Pharmaceuticals treatment of nonsegmental stimulating hormone Ltd. vitiligo. Scenesse Afamelanotide Scenesse is intended for the Alpha-melanocyte Europen Union Clinuvel Pharmaceuticals treatment of nonsegmental stimulating hormone Ltd. vitiligo.

Phase I: Implant-Related Rx Drugs and Biologics

Name Chemical Indication Drug Class Country Developer/Marketer BMP-655 — BMP-655 is intended for the — United States Pfizer Inc. surgical repair of tendons. ITCA 638 — ITCA 638 is intended for Th1 cytokine United States Intarcia Therapeutics Inc. the treatment of chronic hepatitis C. ITCA 880 — ITCA 880 is intended for the Endocrine peptide United States Intarcia Therapeutics Inc. treatment of obesity. ITCA 884 — ITCA 884 is intended for the Endocrine peptide United States Intarcia Therapeutics Inc. treatment of obesity. Probuphine Buprenorphine Probuphine is intended for — United States Titan Pharmaceuticals Inc. and ethylene vinyl the treatment of chronic acetate pain.

Preclinical: Implant-Related Rx Drugs and Biologics

Name Chemical Indication Drug Class Country Developer/Marketer NP201 — NP201 is intended for the Dopamine agonist United States NuPathe Inc. treatment of Parkinson’s disease. NP202 — NP202 is intended for — United States NuPathe Inc. the treatment of bipolar disorder. NP202 — NP202 is intended for the — United States NuPathe Inc. treatment of schizophrenia.

Source: eKnowledgeBase (eknowledgebase.com) 36 Developers and Marketers for Implant-Related Rx Drugs and Biologics

Alimera Sciences Inc. Endo Pharmaceuticals Inc. NuPathe Inc. 6120 Windward Pkwy., Suite 290 100 Endo Blvd., Chadds Ford, PA 19317, United States 375 East Elm St., Suite 110 Alpharetta, GA 30005, United States Phone: 610-558-9800 Conshohocken, PA 19428, United States Phone: 678-990-5740 Fax: 610-558-8979 Phone: 484-567-0130 Fax: 678-990-5744 Website: www.endo.com Fax: 484-567-0136 Website: www.alimerasciences.com Email: [email protected] Year established: 2003 Innocoll Inc. Website: www.nupathe.com 42662 Kitchen Prim Ct. Baxter Healthcare Corp. Ashburn, VA 20148, United States Pfizer Inc. One Baxter Pkwy. Email: [email protected] 235 East 42nd St. Deerfield, IL 60015, United States Website: www.innocollinc.com New York, NY 10017-5755, United States Phone: 847-948-2000 Phone: 212-733-2323 Fax: 847-948-3642 Intarcia Therapeutics Inc. Fax: 212-733-7851 Website: www.baxter.com 24650 Industrial Blvd. Email: [email protected] Hayward, CA 94545, United States Website: www.pfizer.com Bayer HealthCare Pharmaceuticals Phone: 510-782-7800 Year established: 1849 Mueller Strasse 178 Fax: 510-782-7801 Berlin, Mitte 13353, Germany Website: www.intarcia.com pSivida Ltd. Phone: +49 3 04 681 111 Year established: 1997 PO Box 94 Fax: +49 3 04 681 5305 North Perth, WA 6906, Australia Email: [email protected] Merck & Co. Phone: +61 8 9227 8327 Website: www.bayerscheringpharma.de One Merck Dr., PO Box 100 Fax: +61 8 9227 6838 Year established: 2006 (Schering AG: 1871) Whitehouse Station, NJ 08889-0100, United States Website: www.psivida.com Phone: 908-423-1000 Clinuvel Pharmaceuticals Ltd. Website: www.merck.com Titan Pharmaceuticals Inc. 330 Collins St., Level 11 Year established: 1891 400 Oyster Point Blvd., Suite 505 Melbourne, Victoria VIC 3000, Australia South San Francisco, CA 94080, United States Phone: +61 3 9660 4900 Neurotech USA Inc. Phone: 650-244-4990 Fax: +61 3 9660 4999 701 George Washington Hwy. Fax: 650-244-4956 Email: [email protected] Lincoln, RI 02865, United States Email: [email protected] Website: www.clinuvel.com Phone: 401-333-3880 Website: www.titanpharm.com Year established: 1999 Fax: 401-495-2420 Year established: 1992 Email: [email protected] Website: www.neurotechusa.com

Source: eKnowledgeBase (eknowledgebase.com)

Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheters, Suction, Tracheobronchial BSY Tracheobronchial suction catheter. 868.6810 Ac Healthcare Supply, Inc. Catheters, Suction, Tracheobronchial BSY AMSINO catheters and kits are available 868.6810 Amsino International, Inc. with control ports in a full range of French sizes. Catheters, Suction, Tracheobronchial BSY Suction catheter. 868.6810 Ballard Medical Products Catheters, Suction, Tracheobronchial BSY Various sizes of sterile suction catheters and 868.6810 Baxter Productos Medicos, sets containing suction catheters Ltda. Catheters, Suction, Tracheobronchial BSY 868.6810 Benlan Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Centurion Medical Products Corp. Catheters, Suction, Tracheobronchial BSY Various sizes of amsino suction catheters 868.6810 Changchun Amsino Medical Instrument Co., Ltd. Catheters, Suction, Tracheobronchial BSY Catheters, suction, tracheobronchial 868.6810 Changshu Taining High Polymer Medical Products Co. Catheters, Suction, Tracheobronchial BSY Various types of sterile suction catheters 868.6810 Corpak Medsystems, Inc. and accessories. Catheters, Suction, Tracheobronchial BSY SUCTION CATHETER 868.6810 Cw Medical, Inc. Catheters, Suction, Tracheobronchial BSY Various tracheobronchial suction catheters, 868.6810 Deroyal Surgical - Rose Hill sterile and non-sterile. Catheters, Suction, Tracheobronchial BSY 868.6810 Filtrona Extrusion, Inc./ PexcoÂ® Medical Products Div. Catheters, Suction, Tracheobronchial BSY Suction catheters, thumb and vacuum 868.6810 Global Healthcare control connectors. Catheters, Suction, Tracheobronchial BSY 868.6810 J.H. Orsing Ab Catheters, Suction, Tracheobronchial BSY Suction catheters and suction catheter kits 868.6810 Kelsar, S.A. (various)

Source: MDRWeb.com 37 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheters, Suction, Tracheobronchial BSY Catheters, suction tracheobronchial. 868.6810 Kentron Health Care, Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Kimura Medical Instrument Co. Ltd. Catheters, Suction, Tracheobronchial BSY 868.6810 Medline Industries, Inc. Catheters, Suction, Tracheobronchial BSY Suction catheters. 868.6810 Medline Manufacturing And Services Llc Catheters, Suction, Tracheobronchial BSY 868.6810 Merlyn Pharmaceuticals, Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Porges S.A. Catheters, Suction, Tracheobronchial BSY 868.6810 Repro-Med Systems, Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Richard Wolf Medical Instruments Corp. Catheters, Suction, Tracheobronchial BSY 868.6810 Rico Suction Labs, Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Rockford Medical & Safety Co. Catheters, Suction, Tracheobronchial BSY Various 868.6810 Romsons Intl. Catheters, Suction, Tracheobronchial BSY Suction catheter. 868.6810 Shoney Scientific, Inc. Catheters, Suction, Tracheobronchial BSY Meconium aspirator. 868.6810 Smiths Medical Asd Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 State Trading Corporation Of India, Ltd. Catheters, Suction, Tracheobronchial BSY Pmma bone cement. 868.6810 Stryker Puerto Rico, Ltd. Catheters, Suction, Tracheobronchial BSY Suction catheter. 868.6810 Team Technologies, Inc. Catheters, Suction, Tracheobronchial BSY Specimen trap. 868.6810 Terumo Cardiovascular Systems (Tcvs) Catheters, Suction, Tracheobronchial BSY Tnc suction holder. 868.6810 Tnc Devices, Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Trinity Sterile, Inc. Catheters, Suction, Tracheobronchial BSY 868.6810 Tri-State Hospital Supply Corp. Catheters, Suction, Tracheobronchial BSY Suction catheters and suction catheter kits 868.6810 Tyco Healthcare Ireland (various) Limited Catheters, Suction, Tracheobronchial BSY 868.6810 Unomedical, Inc. Catheters, Suction, Tracheobronchial BSY Hand-operated emergency suction device, 868.6810 Virtec Enterprises, Llc “Suction Easy.” Catheters, Suction, Tracheobronchial BSY 868.6810 Vygon Corp. Catheters, Suction, Tracheobronchial BSY Suction catheter (sterile) 868.6810 Vygon S A Condenser, Heat And Moisture BYD Various types of artificial nose. 868.5375 Amerivac Usa Inc. (Artificial Nose) Condenser, Heat And Moisture BYD Artificial nose 868.5375 Ashitaka Factory Of Terumo (Artificial Nose) Corporation Condenser, Heat And Moisture BYD Ballard flex. 868.5375 Ballard Medical Products (Artificial Nose) Condenser, Heat And Moisture BYD Heat and moisture exchanger (hme) and 868.5375 Hudson Rcj Ab (Artificial Nose) accessories Condenser, Heat And Moisture BYD HYDRO-TRACH T, HYDRO-THERM, FILTA- 868.5375 Intersurgical Inc. (Artificial Nose) THERM, CLEAR-THERM. Condenser, Heat And Moisture BYD Various common names 868.5375 Kapitex Healthcare, Ltd. (Artificial Nose) Condenser, Heat And Moisture BYD Various 868.5375 Kiewclass (M) Sdn Bhd (Artificial Nose) Condenser, Heat And Moisture BYD 868.5375 King Systems Corp. (Artificial Nose) Condenser, Heat And Moisture BYD Heat moisture exchanger/artificial nose. 868.5375 Medicomp (Artificial Nose) Condenser, Heat And Moisture BYD Various. 868.5375 Pall Corporation (Artificial Nose) Condenser, Heat And Moisture BYD Various. 868.5375 Pall Lifesciences Puerto Rico (Artificial Nose) Llc Condenser, Heat And Moisture BYD Heat and moisture exchanger. 868.5375 Smiths Medical Asd Inc. (Artificial Nose)

Source: MDRWeb.com 38 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Condenser, Heat And Moisture BYD 868.5375 Sunmed Usa Llc. (Artificial Nose) Condenser, Heat And Moisture BYD Condenser. 868.5375 Synergetics Usa, Inc. (Artificial Nose) Condenser, Heat And Moisture BYD Artificial nose, heat & moisture exchanger. 868.5375 Ventlab Corp. (Artificial Nose) Catheter, Nasal, Oxygen BZB 868.5350 Allied Healthcare Products, Inc. Catheter, Nasal, Oxygen BZB 868.5350 Applied Medical Technology, Inc. Catheter, Nasal, Oxygen BZB Various types of nasal catheters, oxygen 868.5350 Baur Und Haselbarth-Chirurg Gmbh Catheter, Nasal, Oxygen BZB Various sizes of catheters 868.5350 Baxter Productos Medicos, Ltda. Catheter, Nasal, Oxygen BZB 868.5350 Covidien Lp Catheter, Nasal, Oxygen BZB Catheter, nasal, oxygen 868.5350 M.J. Instruments Company (Pvt) Ltd. Catheter, Nasal, Oxygen BZB For use with #1543 Aspirator. 868.5350 Mada, Inc. Catheter, Nasal, Oxygen BZB Oxygen nasal catheter 868.5350 Md Productos Medicos Catheter, Nasal, Oxygen BZB 868.5350 Medline Industries, Inc. Catheter, Nasal, Oxygen BZB 868.5350 Vygon Corp. Stethoscope, Esophageal BZW 868.1910 Aisling Industries Stethoscope, Esophageal BZW 868.1910 Covidien Lp Stethoscope, Esophageal BZW With temperature thermistor. 868.1910 Covidien Lp, Formerly Registered As Kendall Stethoscope, Esophageal BZW Esophageal stethoscope. 868.1910 Deroyal Surgical - Rose Hill Stethoscope, Esophageal BZW 868.1910 Ge Industrial, Sensing Stethoscope, Esophageal BZW Disposable esophageal stethoscope. 868.1910 Kentron Health Care, Inc. Stethoscope, Esophageal BZW To monitor heart /breath sounds and 868.1910 Novamed, Llc temperature with 400 and 700 Series Thermistor. Available sizes 9FR, 12FR, 18FR and 24FR. Packaged in boxes of 40 pcs/ cases of 160. Stethoscope, Esophageal BZW 868.1910 Philips Medical Systems, New Clinical Ventures Stethoscope, Esophageal BZW 868.1910 Sun-Med Cannula, Nasal, Oxygen CAT Oxygen nasal cannula. 868.5340 Afton Medical Llc Cannula, Nasal, Oxygen CAT 868.5340 Allied Healthcare Products, Inc. Cannula, Nasal, Oxygen CAT $49.22 for case of 50. 868.5340 A-M Systems, Inc. Cannula, Nasal, Oxygen CAT Oxy-Ears Nasal Cannula, Oxy-ears, Oxy- 868.5340 American Medical Products, Nose Inc. Cannula, Nasal, Oxygen CAT Cannula. 868.5340 Caplugs West Cannula, Nasal, Oxygen CAT Same 868.5340 Combined Instruments (Pvt.), Ltd. Cannula, Nasal, Oxygen CAT Strap accessory to cannula tubes. 868.5340 Comfort Strap Co. Cannula, Nasal, Oxygen CAT 868.5340 Covidien (Formerly Nellcor Puritan Bennett / Tyco Healthcare) Cannula, Nasal, Oxygen CAT 868.5340 Covidien Lp Cannula, Nasal, Oxygen CAT Oxygen cannula 868.5340 Delta Systems De Mexico Cannula, Nasal, Oxygen CAT 868.5340 Directmed, Inc. Cannula, Nasal, Oxygen CAT OXYBLOC disposable bite block with nasal 868.5340 Gi Supply cannula. Cannula, Nasal, Oxygen CAT Cpap nasal cannula 868.5340 Kelsar, S.A. Cannula, Nasal, Oxygen CAT Nasal cannula. 868.5340 Kentron Health Care, Inc. Cannula, Nasal, Oxygen CAT 868.5340 Lampac International Ltd.

Source: MDRWeb.com 39 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Cannula, Nasal, Oxygen CAT LIFE cannulas. 868.5340 Life Corporation Cannula, Nasal, Oxygen CAT Box of 25 in 7ft. or 25ft. length. 868.5340 Mada, Inc. Cannula, Nasal, Oxygen CAT Nasal cannula 868.5340 Md Productos Medicos Cannula, Nasal, Oxygen CAT No common name listed. 868.5340 Medicomp Cannula, Nasal, Oxygen CAT 868.5340 Meditrade Medical Trading Gmbh Cannula, Nasal, Oxygen CAT 868.5340 Medline Industries, Inc. Cannula, Nasal, Oxygen CAT 868.5340 Omni Medical Supply Inc. Cannula, Nasal, Oxygen CAT Oxy-view nasal cannula. 868.5340 Oxy-View, Inc. Cannula, Nasal, Oxygen CAT 868.5340 Penox Technologies, Inc. Cannula, Nasal, Oxygen CAT 868.5340 Rockford Medical & Safety Co. Cannula, Nasal, Oxygen CAT Sterile and non-sterile two pronged nasal 868.5340 Romsons Intl. oxygen cannula Cannula, Nasal, Oxygen CAT Multiple 868.5340 Salter Labs Cannula, Nasal, Oxygen CAT 4800 SERIES DEMAND ; SALTER STYLE 868.5340 Salter Labs CANNULA Cannula, Nasal, Oxygen CAT Various types of oxygen cannulas. 868.5340 Smiths Medical Asd Inc. Cannula, Nasal, Oxygen CAT Nasal cannula. 868.5340 Smiths Medical Asd, Inc. Cannula, Nasal, Oxygen CAT Nasal cannula. 868.5340 Superior Products, Inc. Cannula, Nasal, Oxygen CAT Cannulae, various types and sizes (sterile & 868.5340 Tyco Healthcare Ireland non-sterile) Limited Cannula, Nasal, Oxygen CAT Nasal oxygen cannula. 868.5340 Vital Signs Colorado Cannula, Nasal, Oxygen CAT 868.5340 Vygon Corp. Bag, Polymeric Mesh, Pacemaker DSW Mesh bags. 870.3650 Bard Shannon Limited Bag, Polymeric Mesh, Pacemaker DSW 870.3650 Plastic And Metal Center, Inc. Magnet, Test, Pacemaker DTG Model 220, Patient Magnet 870.3690 Cyberonics, Inc. Magnet, Test, Pacemaker DTG 870.3690 Instromedix, A Card Guard Co. Magnet, Test, Pacemaker DTG Magnet. 870.3690 Trivirix International Inc. Sizer, Heart Valve Prosthesis DTI 3f Handle; 3f Sizers; Accessory Tray; Open 870.3945 ATS Medical, Inc. Pivot Handles; Open Pivot Heart Valve Sizer; Simulus Handle; Simulus Sizers Sizer, Heart Valve Prosthesis DTI 870.3945 Ats Medical, Inc. Sizer, Heart Valve Prosthesis DTI HEART-VALVE; PROSTHESIS; SIZER 870.3945 Edwards Lifesciences, Llc. Sizer, Heart Valve Prosthesis DTI Prosthetic heart valve sizer.; ENDOSCOPIC 870.3945 Intuitive Surgical, Inc. VALVE SIZER Sizer, Heart Valve Prosthesis DTI Heart valve sizers 870.3945 Medical Carbon Research Institute-Deutschland Gmbh Sizer, Heart Valve Prosthesis DTI Sizer or obturator. 870.3945 Medtronic Cardiovascular Surgery, The Heart Valve Div. Sizer, Heart Valve Prosthesis DTI Sizer or obturator. 870.3945 Medtronic Heart Valves Sizer, Heart Valve Prosthesis DTI Heart valve sizers. 870.3945 On-X Life Technologies, Inc. Holder, Heart Valve Prosthesis DTJ Open Pivot Handle; Open Pivot Hex End 870.3935 ATS Medical, Inc. Rotator; Open Pivot Holder Holder, Heart Valve Prosthesis DTJ 870.3935 Ats Medical, Inc. Holder, Heart Valve Prosthesis DTJ 870.3935 Edwards Lifesciences, Llc. Holder, Heart Valve Prosthesis DTJ Holder or collet. 870.3935 Medtronic Cardiovascular Surgery, The Heart Valve Div. Holder, Heart Valve Prosthesis DTJ Holder or collet. 870.3935 Medtronic Heart Valves Teeth, Artificial, Posterior With Metal ELJ 872.3900 Advanced Aesthetic Insert Solutions Teeth, Artificial, Posterior With Metal ELJ Dental prosthesis. 872.3900 Aurum Ceramic Dental Insert Laboratories Llp Teeth, Artificial, Posterior With Metal ELJ 872.3900 Dentsply Canada, Ltd. Insert

Source: MDRWeb.com 40 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Teeth, Artificial, Posterior With Metal ELJ 872.3900 Dentsply International, Inc. Insert Teeth, Artificial, Posterior With Metal ELJ 872.3900 Dentsply Prosthetics Insert Teeth, Artificial, Posterior With Metal ELJ Pfm,crown & bridge. 872.3900 Intergrated Dental Solutions, Insert Inc. Teeth, Artificial, Posterior With Metal ELJ Fabricated porcelain tooth with metal 872.3900 Ivory Dental Laboratory Insert insert. Teeth, Artificial, Posterior With Metal ELJ Types of artifical teeth. 872.3900 Kainos Dental Laboratory Insert Teeth, Artificial, Posterior With Metal ELJ Crowns and bridges / dental. 872.3900 Orchid Dental Studio, Inc Insert Teeth, Artificial, Posterior With Metal ELJ O-so dental attachment. 872.3900 Scodenco, Inc. Insert Teeth, Artificial, Backing And Facing ELK JUSTI IMPERIAL acrylic teeth and plastic 872.3910 American Tooth Industries blended facings. Teeth, Artificial, Backing And Facing ELK Vinyl teeth. 872.3910 Astron Dental Corporation Teeth, Artificial, Backing And Facing ELK 872.3910 Candulor Dental Gmbh Teeth, Artificial, Backing And Facing ELK 872.3910 Dentsply Canada, Ltd. Teeth, Artificial, Backing And Facing ELK 872.3910 Dentsply International, Inc. Teeth, Artificial, Backing And Facing ELK 872.3910 Hahnenkratt Gmbh Teeth, Artificial, Backing And Facing ELK Gold coping,crown & bridge. 872.3910 Intergrated Dental Solutions, Inc. Teeth, Artificial, Backing And Facing ELK Acrylic resin teeth, anterior and posterior 872.3910 Ivoclar A.G. Teeth, Artificial, Backing And Facing ELK 872.3910 Ivoclar Vivadent, Inc. Teeth, Artificial, Backing And Facing ELK Supercryl, acrulic teeth 872.3910 Jamaica Dental & Chemical Laboratory Ltd. Teeth, Artificial, Backing And Facing ELK 872.3910 Lactona Corporation Teeth, Artificial, Backing And Facing ELK Various 872.3910 Ra.Mo S.N.C. Di Rangoni & Co. Teeth, Artificial, Backing And Facing ELK 872.3910 Servo-Dental Teeth, Artificial, Backing And Facing ELK Coping, crown, inlay, onlay, veneer. 872.3910 Tds U-Best Dental Technology Teeth, Preformed Gold Denture ELN 872.3580 Hennessy Dental Laboratory Teeth, Preformed Gold Denture ELN Denture. 872.3580 Hong Kong Dental Lab Teeth, Preformed Gold Denture ELN 872.3580 Masel Co., Inc. Catheter, Nasopharyngeal ENW Available in a variety of sizes and styles. 874.4175 Anesthesia Associates, Inc. Catheter, Nasopharyngeal ENW 874.4175 Medline Industries, Inc. Catheter, Nasopharyngeal ENW RhinoCath a nasal catheter and tampon 874.4175 Micromedics for intra- and post-operative nasal bleeding. Larynx, Artificial (Battery-Powered) ESE Battery powered artificial larynx 874.3375 Amplicord Di G. Salvatore Larynx, Artificial (Battery-Powered) ESE Artificial larynx. 874.3375 Cyberbiomed, Llc Larynx, Artificial (Battery-Powered) ESE Artificial larynx, electrolarynx. 874.3375 Drb Technologies, Inc Larynx, Artificial (Battery-Powered) ESE 874.3375 E. Benson Hood Laboratories, Inc. Larynx, Artificial (Battery-Powered) ESE Artificial larynx, electronic. 874.3375 Griffin Laboratories Larynx, Artificial (Battery-Powered) ESE Battery-powered artificial larynx. 874.3375 Justmed, Inc. Larynx, Artificial (Battery-Powered) ESE $425.00 for COOPER-RAND intraoral models 874.3375 Luminaud, Inc. (three types for hand mobility problems). $440.00 for DENRICK 3 neck held artificial larynx, used with oral adapter. Larynx, Artificial (Battery-Powered) ESE Battery powered artificial larynx. 874.3375 Mountain Precision Mfg. Ltd. Co. Larynx, Artificial (Battery-Powered) ESE Electronic larynx. 874.3375 Park Surgical Co., Inc. Larynx, Artificial (Battery-Powered) ESE Battery powered artificial larynx 874.3375 Servox Medizintechnik Gmbh Larynx, Artificial (Battery-Powered) ESE Electronically hand held electrolarynx which 874.3375 Smiths Medical Asd produces auditory vibrations for voice production in laryngectomees.

Source: MDRWeb.com 41 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Larynx, Artificial (Battery-Powered) ESE Artificial larynx. 874.3375 Ultravoice, Ltd. Device, Incontinence, Urosheath EXJ External male continence device. 876.5250 Bioderm, Inc. Type, Sterile Device, Incontinence, Urosheath EXJ Extended Wear Self-Adhesive Incontinence 876.5250 Hollister Incorporated Type, Sterile Sheath Incore Inview Male External Catheter Device, Incontinence, Urosheath EXJ Texas catheter, external catheter, and 876.5250 Kelsar, S.A. Type, Sterile accessories Device, Incontinence, Urosheath EXJ WEIMER. 876.5250 Ldb Medical, Inc. Type, Sterile Device, Incontinence, Urosheath EXJ Offerings include a range of devices and 876.5250 Leading Edge Innovations Type, Sterile accessories for male urinary incontinence. Device, Incontinence, Urosheath EXJ 876.5250 Medline Industries, Inc. Type, Sterile Device, Incontinence, Urosheath EXJ Self-adhesive, male, external catheters, leg 876.5250 Mentor Corp. Type, Sterile bags, catheter straps. Female catheters, connecting tubing. Device, Incontinence, Urosheath EXJ Male incontinent device. 876.5250 Perma Type Company, Inc. Type, Sterile Device, Incontinence, Urosheath EXJ 876.5250 Porges S.A. Type, Sterile Device, Incontinence, Urosheath EXJ Male external catheter. 876.5250 Reach Global Industries, Inc. Type, Sterile (Reachgood) Device, Incontinence, Urosheath EXJ External catheter. 876.5250 Rochester Medical Corp. Type, Sterile Adapter, Ureteral Catheter EYI 876.5130 Boston Scientific Corporation Adapter, Ureteral Catheter EYI 876.5130 Cook Urological, Inc. Adapter, Ureteral Catheter EYI No common name listed 876.5130 Mapa Gmbh Gummi- Und Plastikwerke Holder, Ureteral Catheter EYJ Urological catheter and accessories. 876.5130 Ac Healthcare Supply, Inc. Holder, Ureteral Catheter EYJ Catheter holder. 876.5130 Advanced Materials, Inc. Holder, Ureteral Catheter EYJ 876.5130 Aesculap Implant Systems Inc. Holder, Ureteral Catheter EYJ 876.5130 Aplix, Inc. Holder, Ureteral Catheter EYJ 876.5130 Armstrong Medical Industries, Inc. Holder, Ureteral Catheter EYJ Catheter tube holder for leg; waist, hospital 876.5130 A-T Surgical Manufacturing utility grip and nasogastric tube holder. Co., Inc. Holder, Ureteral Catheter EYJ Foley Catheter Tube Holder: #316 legband, 876.5130 Dale Medical Products, Inc. fits most adults; #330 legband/waistband, fits most adults Holder, Ureteral Catheter EYJ Foley catheter holder. 876.5130 Eclipse Medical, Inc. Holder, Ureteral Catheter EYJ Urethral catheter holder. 876.5130 Insight Biodesign Llc Holder, Ureteral Catheter EYJ SUPERERECTA, STARSYS. 876.5130 Intermetro Industries Corp. Holder, Ureteral Catheter EYJ Catheter holder/legband. 876.5130 Kentron Health Care, Inc. Holder, Ureteral Catheter EYJ 876.5130 M.C. Johnson Co., Inc. Holder, Ureteral Catheter EYJ Catheter tube holders and fasteners. 876.5130 Medi-Crush Company Eliminates prepping and taping. Holds catheter securely. Flexible and hypoallergenic adhesive. Holder, Ureteral Catheter EYJ NEOBRIDGE: Umbilical catheter holder 876.5130 Neotech Products, Inc. uses skin friendly hydrocolloid to attach to patient. Holder, Ureteral Catheter EYJ Catheter storage racks. 876.5130 Sargent Co. Holder, Ureteral Catheter EYJ 876.5130 Skil-Care Corp. Holder, Ureteral Catheter EYJ $25.00 per package of 25 Foley catheter 876.5130 Taylor Medical Products holders. Connector, Ureteral Catheter EYK 876.5130 Boston Scientific Corporation Connector, Ureteral Catheter EYK 876.5130 Porges S.A.

Source: MDRWeb.com 42 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Stylet for Catheter, Gastro-Urology EZB 876.5130 Accellent Inc. Stylet for Catheter, Gastro-Urology EZB Tunneling stylets in multiple lumen catheter 876.5130 Angiodynamics, Inc. kits. Stylet for Catheter, Gastro-Urology EZB 876.5130 Boston Scientific Corporation Stylet for Catheter, Gastro-Urology EZB Various types of catheter stylets. 876.5130 Greenwald Surgical Co., Inc. Instrument, Catheter, Punch FEX 876.5090 Aesculap Implant Systems Inc. Instrument, Catheter, Punch FEX 876.5090 Cook Urological, Inc. Instrument, Catheter, Punch FEX Various types of punches 876.5090 Robert Mueller Instrumente Expander, Surgical, Skin Graft FZW Expander, surgical, skin graft. 878.4800 Biomet Microfixation Inc. Expander, Surgical, Skin Graft FZW Skin graft mesher. 878.4800 Brennen Medical, Llc Expander, Surgical, Skin Graft FZW Same 878.4800 Combined Instruments (Pvt.), Ltd. Expander, Surgical, Skin Graft FZW Graft surgical. 878.4800 Lenox-Maclaren Surgical Corp. Expander, Surgical, Skin Graft FZW 878.4800 Mc Ghan Medical S.A. Expander, Surgical, Skin Graft FZW 878.4800 Mc Ghen Medical S.R.L. Expander, Surgical, Skin Graft FZW 878.4800 Pmt Corp. Expander, Surgical, Skin Graft FZW 878.4800 Zimmer Holdings, Inc. Expander, Surgical, Skin Graft FZW 878.4800 Zimmer Orthopaedic Surgical Products Retractor GAD Orthopedic retractor 878.4800 Baur Und Haselbarth-Chirurg Gmbh Retractor GAD DURA RETRACTOR 878.4800 Blackstone Medical, Inc. Retractor GAD Ophthalmic, vascular/cardiovascular, 878.4800 Boss Instruments, Ltd. ENT, plastic surgery; neurosurgical, spine (cervical and lumbar), orthopedic, micro surgery, general surgery. Retractor GAD 878.4800 Carl Heyer, Inc. Retractor GAD Various 878.4800 Christian Diener Gmbh. & Co. K.G. Retractor GAD CLOWARD Double hinge retractor. 878.4800 Cloward Instrument Corporation Retractor GAD Same 878.4800 Combined Instruments (Pvt.), Ltd. Retractor GAD ReeTrakt 878.4800 Csi Holdings Retractor GAD Various 878.4800 Diwymed Production Gmbh Retractor GAD 878.4800 Elmed, Inc. Retractor GAD 878.4800 Fine Surgical Instrument, Inc. Retractor GAD Various 878.4800 G.U. Medical Ltd. Retractor GAD HEART-LIFT Cardiac Retraction Sling. 878.4800 Genesee Biomedical, Inc. Provides easy access to the circumflex branch of the coronary artery. Retractor GAD 878.4800 George Tiemann & Co. Retractor GAD Retractor, orthopedic 878.4800 Hartmut Willutzki Retractor GAD 878.4800 International Hospital Supply Co. Retractor GAD 878.4800 Kapp Surgical Instrument, Inc. Retractor GAD 878.4800 Karl Storz Endoscopy- America Inc. Retractor GAD 878.4800 Kmedic Retractor GAD 878.4800 Medicon Eg Retractor GAD 878.4800 Mediflex Surgical Products Retractor GAD 878.4800 Microsurgical Laboratories Retractor GAD MIS-TKA Technique Specific Retractor Set. 878.4800 Nemcomed

Source: MDRWeb.com 43 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Retractor GAD OmniAccess table-mounted retractor for 878.4800 Omni-Tract Surgical, A Div. Of total hip arthroplasty and revisions improves Minnesota Scientific, Inc. exposure and eliminates assistants. Retractor GAD Bent, anterior acetabular, posterior 878.4800 Signal Medical Corporation acetabular (left)with or without light cord brackets, and posterior acetabular (right) retractors with or without light cord brackets. Retractor GAD Various 878.4800 Stille Surgical Ab Retractor GAD 878.4800 Stryker Corp. Retractor GAD 878.4800 Stryker Pacific Retractor GAD 878.4800 Stryker Spine Retractor GAD 878.4800 Tuzik Boston Retractor GAD 878.4800 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Retractor GAD 878.4800 Zimmer Holdings, Inc. Catheter, Balloon Type GBA 878.4200 Arrow International, Inc. Catheter, Balloon Type GBA 878.4200 Axiom Medical, Inc. Catheter, Balloon Type GBA Various 878.4200 Boston Scientific Ireland, Ltd. Catheter, Balloon Type GBA Balloon catheter. 878.4200 Boston Scientific- Neurovascular Catheter, Balloon Type GBA Custom balloon catheters. 878.4200 California Medical Innovations Catheter, Balloon Type GBA SAVI Preparation Device 878.4200 Cianna Medical, Inc. Catheter, Balloon Type GBA Introducers. 878.4200 Clinical Instruments Intl., Inc. Catheter, Balloon Type GBA Various balloon extraction and dilation 878.4200 Cook Endoscopy catheters. Catheter, Balloon Type GBA 878.4200 Covidien Lp Catheter, Balloon Type GBA FO-LY-CATH catheter. 878.4200 Covidien Lp, Formerly Registered As Kendall Catheter, Balloon Type GBA Intra-aortic balloon catheter. 878.4200 Datascope Cardiac Assist Div. Catheter, Balloon Type GBA Foley catheters and Foley temperature 878.4200 Degania Silicone, Inc. sensor catheters sterile packaged under customer’s private label. Catheter, Balloon Type GBA ENDOPATH cholangiogram with balloon, 878.4200 Ethicon Endo-Surgery, Inc. 50cm with 14g, 2.25in. with introducer; cholangiogram, 50cm with 14g, 2.25in. with introducer. Catheter, Balloon Type GBA Disposable, 2-way, 3-way, various French 878.4200 Global Healthcare and balloon volume. Catheter, Balloon Type GBA Balloon catheter, endometrial ablation 878.4200 Gynecare system which is an office-based procedure for the treatment of menorrhagia (dysfunctional uterine bleeding in women). Catheter, Balloon Type GBA Endoscopic dilation balloon. 878.4200 Hobbs Medical, Inc. Catheter, Balloon Type GBA 878.4200 Iberhospitex S.A. Catheter, Balloon Type GBA 878.4200 Kansai Trading Corp. Catheter, Balloon Type GBA Available in latex, silicone. Elastomer 878.4200 Lampac International Ltd. coated latex and 100% silicone. Catheter, Balloon Type GBA Including tri-lumen and temperature 878.4200 Manufacturing & Research, monitoring, 6-30Fr., silicone. Inc.(Dba Mri Medical) Catheter, Balloon Type GBA ONLY AUSTRIBUTE 878.4200 Medline Industries, Inc. Catheter, Balloon Type GBA 878.4200 Mentor Corp. Catheter, Balloon Type GBA Percutataneous transluminal angioplasty 878.4200 Merit Medical Systems, Inc. catheter. Catheter, Balloon Type GBA 878.4200 Merlyn Pharmaceuticals, Inc. Catheter, Balloon Type GBA Pneumatic hand pump. 878.4200 Navilyst Medical

Source: MDRWeb.com 44 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter, Balloon Type GBA NovaTemp Foley Catheters with 878.4200 Novamed, Llc Temperature 100% Silicone -- Available in Sterile Packaging -- Sizes 8FR, 10FR, 12FR, 14FR, 16FR, 18FR. Packaged 10/ Box; 40/ case. Catheter, Balloon Type GBA Nice balloon 878.4200 Optimal Healthcare Products Catheter, Balloon Type GBA 878.4200 Porges S.A. Catheter, Balloon Type GBA 878.4200 Tacpro, Inc. Catheter, Balloon Type GBA 878.4200 Tactx Medical/Produxx, Inc. Catheter, Balloon Type GBA 878.4200 Unomedical, Inc. Catheter, Balloon Type GBA 878.4200 Wilson-Cook Medical, Inc. Catheter, Balloon Type GBA Silicone. Two-way, three-way and Tiemann 878.4200 Yushin Medical Co., Ltd. types available. From 1.5cc to 30cc balloon products. UniBal type catheter(New Integrated balloon catheter for urine drainage) Prosthesis, Adhesive, External GBJ PSA-based adhesive materials for wound 878.3750 Avery Dennison Corporation care, electrodes, surgical drapes, diagnostics, and drug delivery systems. Prosthesis, Adhesive, External GBJ External Components prosthesis and 878.3750 DAW Industries orthodics. Prosthesis, Adhesive, External GBJ 878.3750 Harry J. Bosworth Company Prosthesis, Adhesive, External GBJ LAPIDES. 878.3750 Ldb Medical, Inc. Prosthesis, Adhesive, External GBJ Silicone adhesive. 878.3750 Nearly Me Technologies, Inc. Prosthesis, Adhesive, External GBJ DMA Orthotic and Prosthetic (durable 878.3750 Yellin Inc. medical equipment). Catheter, Pediatric, General & Plastic GBN 878.4200 Axiom Medical, Inc. Surgery Catheter, Pediatric, General & Plastic GBN 878.4200 Merlyn Pharmaceuticals, Inc. Surgery Catheter, Pediatric, General & Plastic GBN CliniCath peripherally inserted catheters 878.4200 Smiths Medical Asd, Inc. Surgery with a full line of catheter sizes and lengths, including adult central and midline placement. Catheter, Pediatric, General & Plastic GBN 878.4200 Vygon Corp. Surgery Catheter, Nephrostomy, General & GBO 878.4200 Boston Scientific Corporation Plastic Surgery Catheter, Nephrostomy, General & GBO 878.4200 Merlyn Pharmaceuticals, Inc. Plastic Surgery Catheter, Nephrostomy, General & GBO 878.4200 Porges S.A. Plastic Surgery Catheter, Nephrostomy, General & GBO 878.4200 Rocket Medical Plc. Plastic Surgery Catheter, Multiple Lumen GBP 878.4200 Angiodynamics, Inc. Catheter, Multiple Lumen GBP Multiple lumen catheter. 878.4200 Argon Medical Devices Inc. Catheter, Multiple Lumen GBP 878.4200 Armm, Inc. Catheter, Multiple Lumen GBP The ams esophageal manometry catheters. 878.4200 Arndorfer Medical Specialties Catheter, Multiple Lumen GBP Adult and pediatric sizes, 2- and 3-lumen 878.4200 Arrow International, Inc. tubing. Catheter, Multiple Lumen GBP Multi lumen catheter. 878.4200 Atek Medical Catheter, Multiple Lumen GBP 878.4200 B. Braun Oem Division, B. Braun Medical Inc. Catheter, Multiple Lumen GBP 878.4200 Becton Dickinson Infusion Therapy Systems, Inc. Catheter, Multiple Lumen GBP $22.00 double and single trays only. 878.4200 Cardiomed Supplies Inc. Catheter, Multiple Lumen GBP Introducers. 878.4200 Clinical Instruments Intl., Inc. Catheter, Multiple Lumen GBP 878.4200 Hospira, Inc. Catheter, Multiple Lumen GBP Various types. 878.4200 Icu Medical (Ut), Inc

Source: MDRWeb.com 45 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter, Multiple Lumen GBP 6-30 Fr., silicone. 878.4200 Manufacturing & Research, Inc.(Dba Mri Medical) Catheter, Multiple Lumen GBP 878.4200 Merlyn Pharmaceuticals, Inc. Catheter, Multiple Lumen GBP 878.4200 Smiths Medical Asd, Inc. Catheter, Multiple Lumen GBP 878.4200 Sunlite Plastics, Inc. Catheter, Multiple Lumen GBP Rectal/colon irrigator. 878.4200 Tools For Surgery, Llc Catheter, Multiple Lumen GBP 878.4200 Vygon Corp. Catheter, Multiple Lumen GBP Multiple lumen catheter (sterile) 878.4200 Vygon S A Catheter, Continuous Irrigation GBQ 878.4200 Armm, Inc. Catheter, Continuous Irrigation GBQ Introducers. 878.4200 Clinical Instruments Intl., Inc. Catheter, Continuous Irrigation GBQ Oral gastric tube. 878.4200 Cook Endoscopy Catheter, Continuous Irrigation GBQ 878.4200 Medline Industries, Inc. Catheter, Continuous Irrigation GBQ 878.4200 Merlyn Pharmaceuticals, Inc. Catheter, Continuous Irrigation GBQ General procedure catheterization 878.4200 Utah Medical Products, Inc. tray, specialized tray for minor surgical procedures: umbilical catheter placements, cut downs, circumcisions, etc. Catheter, Ventricular, General & GBS ATAKR. 878.4200 Medtronic, Inc. Plastic Surgery Catheter, Peritoneal GBW Capd cather support undergarment. 878.4200 Access Llc Catheter, Peritoneal GBW Neonatal, pediatric, adult, and custom 878.4200 Angiodynamics, Inc. configurations in 16 silicone models including coiled, straight, and variable, with one universal placement kit. Catheter, Peritoneal GBW Penrose drain. 878.4200 Deroyal Surgical - Rose Hill Catheter, Peritoneal GBW Intraducer. 878.4200 Geneva Medical Inc. Catheter, Peritoneal GBW Various sites and configurations. 878.4200 Integra Neurosciences Pr Catheter, Peritoneal GBW Multiple 878.4200 Janin Group, Inc. Catheter, Peritoneal GBW Penrose drain, non-latex. 878.4200 Kent Elastomer Products, Inc Catheter, Peritoneal GBW 878.4200 Plasti Medical S.P.A. Catheter, Peritoneal GBW 878.4200 Smiths Medical Asd, Inc. Catheter, Peritoneal GBW 878.4200 Taut, Inc. Catheter, Peritoneal GBW Gore-tex peritoneal catheter. 878.4200 W.L. Gore & Associates,Inc Catheter, Irrigation GBX Introduction/drainage catheter & 878.4200 Ac Healthcare Supply, Inc. accessories. Catheter, Irrigation GBX 878.4200 Angiodynamics, Inc. Catheter, Irrigation GBX Latex-free irrigation catheters. 878.4200 Applied Medical Resource Corporation Catheter, Irrigation GBX 878.4200 Armm, Inc. Catheter, Irrigation GBX Endotracheal medication catheter. 878.4200 Autovage Catheter, Irrigation GBX Drain system with detachable trocar and 878.4200 Axiom Medical, Inc. various collection devices for draining cysts, hematomata through single site. Multiple sizes single & multiple lumen blunt & sharp trocars. Catheter, Irrigation GBX Irrigation catheter. 878.4200 Ballard Medical Products Catheter, Irrigation GBX Irrigation catheter 878.4200 Baur Und Haselbarth-Chirurg Gmbh Catheter, Irrigation GBX Irrigation/infusion catheter. 878.4200 Bentec Medical, Inc. Catheter, Irrigation GBX Irrigation catheter. 878.4200 Biomet, Inc. Catheter, Irrigation GBX Introducers. 878.4200 Clinical Instruments Intl., Inc. Catheter, Irrigation GBX Various surgical tubing, irrigation catheters, 878.4200 Deroyal Surgical - Rose Hill sterile and non-sterile. Catheter, Irrigation GBX Middle ear catheter - sterile kit. 878.4200 Durect Corp. Catheter, Irrigation GBX Irrigation catheter. 878.4200 Edwards Lifesciences Technology Sarl

Source: MDRWeb.com 46 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter, Irrigation GBX 878.4200 Edwards Lifesciences, Llc. Catheter, Irrigation GBX 878.4200 Hollister Incorporated Catheter, Irrigation GBX 878.4200 Hollister, Inc. Catheter, Irrigation GBX Irrigation tray. 878.4200 Kentron Health Care, Inc. Catheter, Irrigation GBX Bi-lumen irrigation catheter. 878.4200 Lucas Medical, Inc. Catheter, Irrigation GBX 878.4200 Merlyn Pharmaceuticals, Inc. Catheter, Irrigation GBX 878.4200 Smith & Nephew, Inc. Catheter, Irrigation GBX Handpiece and tubing set. 878.4200 Stryker Puerto Rico, Ltd. Catheter, Irrigation GBX (GASTRIC, COLONIC, ETC.), IRRIGATION AND 878.4200 Sts Division Of Ethox ASPIRATION - LAVAGE TUBE; MULTIPLE International Catheter, Irrigation GBX Catheter, irrigation. 878.4200 Vital Signs Mn, Inc. Catheter, Irrigation GBX 878.4200 Wilson-Cook Medical, Inc. Catheter, Eustachian, General & GBY Various types of eustachian catheters 878.4200 Baur Und Haselbarth-Chirurg Plastic Surgery Gmbh Catheter, Eustachian, General & GBY Ear catheters 878.4200 Erchinger Medizintecnik Plastic Surgery Catheter, Eustachian, General & GBY Thoracentesis tray. 878.4200 Mcpherson Enterprises, Inc. Plastic Surgery Catheter, Eustachian, General & GBY Brass eustachian catherer 878.4200 Nagashima Medical Plastic Surgery Instruments Co., Ltd. Catheter, Cholangiography GBZ 878.4200 American Catheter Corp. Catheter, Cholangiography GBZ Aerostat Cholangiography Catheter. 878.4200 Applied Medical Resource Percutaneous and through trocar Corporation placement with retention cone. Catheter, Cholangiography GBZ Laparoscopic cholangiography catheters. 878.4200 Arrow International, Inc. Catheter, Cholangiography GBZ Cholangiographic/laparoscopic catheter 878.4200 Ashitaka Factory Of Terumo Corporation Catheter, Cholangiography GBZ 878.4200 Coastal Life Systems, Inc. Catheter, Cholangiography GBZ Ercp catheters. 878.4200 Cook Endoscopy Catheter, Cholangiography GBZ 878.4200 Cook Inc. Catheter, Cholangiography GBZ 878.4200 Dma Med-Chem Corporation Catheter, Cholangiography GBZ Cholangiography catheter. 878.4200 Edwards Lifesciences Technology Sarl Catheter, Cholangiography GBZ 878.4200 Edwards Lifesciences, Llc. Catheter, Cholangiography GBZ Sterile cholangiogram catheter. 878.4200 Geneva Medical Inc. Catheter, Cholangiography GBZ Introduction/drainage catheter accessory 878.4200 Ks Medizin + Laser-Technik Catheter, Cholangiography GBZ Features a ribbed balloon design for stable 878.4200 Lemaitre Vascular, Inc. catheter baloon design for stable catheter placement without clamping. Catheter, Cholangiography GBZ Irrigation catheter. 878.4200 Medchannel Llc Catheter, Cholangiography GBZ Tuohy-borst adaptor. 878.4200 Navilyst Medical Catheter, Cholangiography GBZ Rigid needle stock with oval injection port 878.4200 Novosci Corp. angled to enter cystic duct and clipped for no leakage. Catheter, Cholangiography GBZ Catheter set with cannula, tubing, and 878.4200 Ranfac Corp. stopcock; also, disposable laporoscopic cholangiography catheter. Catheter, Cholangiography GBZ Smooth polished tip, rear shoulder, and 878.4200 Taut, Inc. support tube require minimal intubation for successful cholangiography; models M55, M56 and M57 available. Catheter, Cholangiography GBZ Ponsky disposable cholangiography 878.4200 United States Endoscopy catheter with guidewire, standard catheters Group without guidewires. Catheter, Cholangiography GBZ Cholangiography catheter 4.5 French 878.4200 Utah Pioneer Medical, Inc. with introducer and two labeled syringes. Patented valve system (automatic stopcocks) facilitates fluoroscopy.

Source: MDRWeb.com 47 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter, Cholangiography GBZ 878.4200 Wilson-Cook Medical, Inc. Needle, Catheter GCB Various types of catheter sets (sterile). 878.4200 Abbott Diagnostics Intl, Biotechnology Ltd Needle, Catheter GCB Various 878.4200 Allegiance Healthcare Corp. Needle, Catheter GCB Interventional drainage catheters for 878.4200 Angiotech nephrostomy, biliary, and general abcess drainage. Needle, Catheter GCB 878.4200 Becton Dickinson Infusion Therapy Systems, Inc. Needle, Catheter GCB Connector. 878.4200 Bioform Medical, Inc. Needle, Catheter GCB 878.4200 Cadence Science Inc. Needle, Catheter GCB Various sizes of small vein infusion set 878.4200 Changchun Kangda Medical (butterfly needle) Supply Co., Ltd. Needle, Catheter GCB Handle for needle 878.4200 Gip Medizin Technik Gmbh Needle, Catheter GCB Various sizes of sterile and non-sterile 878.4200 Hakko Medical Co., Ltd. dwellcath catheters Needle, Catheter GCB Thoracentesis systems, procedure trays 878.4200 Kelsar, S.A. Needle, Catheter GCB Scalp vein set. 878.4200 Kentron Health Care, Inc. Needle, Catheter GCB Introduction catheter. 878.4200 Orthovita, Inc. Needle, Catheter GCB Epidural catheter 21 g 878.4200 Reganesth Medizintechnik Gmbh Needle, Catheter GCB 878.4200 Tfx Medical Oem Needle, Catheter GCB Various sizes of small wein infusion set 878.4200 Tianjin Hanaco Medical (butterfly needle) Co.,Ltd. Needle, Catheter GCB Various gauges of sterile intravenous 878.4200 Togo Medikit Co., Ltd. catheter Needle, Catheter GCB 878.4200 Unimed S.A. Dilator, Catheter GCC Various sizes of dilator catheters 878.4200 Baur Und Haselbarth-Chirurg Gmbh Dilator, Catheter GCC 878.4200 Boston Scientific Corporation Dilator, Catheter GCC Same 878.4200 Combined Instruments (Pvt.), Ltd. Dilator, Catheter GCC Various types of biliary and pancreatic 878.4200 Cook Endoscopy dilation catheters. Dilator, Catheter GCC Dilators 878.4200 M/S. Perfectra Instruments Dilator, Catheter GCC 878.4200 Martin Gmbh & Co. Kg, Gebr. Dilator, Catheter GCC 878.4200 Tfx Medical Oem Dilator, Catheter GCC Ailator, catheter 878.4200 Vehu Medical Instrumente Gmbh Dilator, Catheter GCC Biliary dilators. 878.4200 Wilson-Cook Medical, Inc. Dilator, Catheter GCC 878.4200 Witte Gmbh Connector, Catheter GCD Various 878.4200 Angiomed Gmbh & Co. Medizintechnik Kg Connector, Catheter GCD Catheter connector 878.4200 Ashitaka Factory Of Terumo Corporation Connector, Catheter GCD 878.4200 Becton Dickinson Infusion Therapy Systems, Inc. Connector, Catheter GCD 878.4200 Benlan Inc. Connector, Catheter GCD 878.4200 Boston Scientific Corporation Connector, Catheter GCD 878.4200 C. R. Bard, Inc., Bard Urological Div. Connector, Catheter GCD 878.4200 Cadence Science Inc. Connector, Catheter GCD 878.4200 Covidien Lp Connector, Catheter GCD 878.4200 Covidien Lp, Formerly Registered As Kendall Connector, Catheter GCD 878.4200 Dynamics Research Corp.

Source: MDRWeb.com 48 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Connector, Catheter GCD 878.4200 Fresenius Medical Care North America Connector, Catheter GCD Catheter mounts and patient connections. 878.4200 Globalmed Inc. Connector, Catheter GCD FloStar Needleless Connector - patented 878.4200 Intravascular Incorporated “dual-valve” needle free connector for use on venous or arterial lines with luer lock or luer slip in intravenous therapy. Available stand alone or on extension sets. Connector, Catheter GCD 878.4200 Kck Industries Connector, Catheter GCD Catheter connectors (various) 878.4200 Kelsar, S.A. Connector, Catheter GCD 878.4200 Martin Gmbh & Co. Kg, Gebr. Connector, Catheter GCD Catheter connectors. 878.4200 Medline Manufacturing And Services Llc Connector, Catheter GCD 878.4200 Medovations, Inc. Connector, Catheter GCD 878.4200 Microcision Llc Connector, Catheter GCD 878.4200 Porges S.A. Connector, Catheter GCD Coiled extension, connecting tube, 878.4200 Rgi Medical Manufacturing catheter connector. Inc. Connector, Catheter GCD 878.4200 Vygon Corp. Adaptor, Catheter GCE 878.4200 Addto, Inc. Adaptor, Catheter GCE Various types of catheter adaptors 878.4200 Baur Und Haselbarth-Chirurg Gmbh Adaptor, Catheter GCE Locking cap for Baxter peritoneal dialysis 878.4200 Baxter Healthcare catheter adapter. Corporation, Renal Adaptor, Catheter GCE 878.4200 Cadence Science Inc. Adaptor, Catheter GCE Various. 878.4200 Hospira, Inc. Adaptor, Catheter GCE Tubing connectors. 878.4200 Medical Action Industries, Inc. Adaptor, Catheter GCE 878.4200 Mercury Medical Adaptor, Catheter GCE 878.4200 Vygon Corp. Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Advanced Ocular Prosthetics Inc. Eye, Artificial, Non-Custom HQH Eye, artificial, non-custom. 886.3200 Albuquerque Eye Prosthetics, Inc. Eye, Artificial, Non-Custom HQH Prosthetic eye. 886.3200 Anderson Eye Prosthetics Eye, Artificial, Non-Custom HQH 886.3200 Austin Ocular Prosthetics Center, Llc Eye, Artificial, Non-Custom HQH Custom artificial eye. 886.3200 Bruce Cook, Prosthetics Eye, Artificial, Non-Custom HQH Prosthetic eyes. 886.3200 Carole Lewis Stolpe’ B.C.O. Eye, Artificial, Non-Custom HQH Custom fitted plastic ocular prosthesis. 886.3200 Carolina Eye Prosthetics, Inc. Eye, Artificial, Non-Custom HQH Prosthetic or artificial eye. 886.3200 Center For Ocular Prosthetics, Llc. Eye, Artificial, Non-Custom HQH 886.3200 Center For Ocular Reconstruction Eye, Artificial, Non-Custom HQH Custom ocular prosthesis. 886.3200 Dallas Eye Prosthetics Eye, Artificial, Non-Custom HQH Custom ocular prosthetics. 886.3200 Daniel T Acosta Eye, Artificial, Non-Custom HQH Eye prosthesis. 886.3200 Dean B. Scott, Ocularist Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Department Of Veterans Affairs Medical Center Eye, Artificial, Non-Custom HQH Custom ocular prosthesis. 886.3200 Doss K. Tannehill - Ocularist Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Erickson Labs Northwest Eye, Artificial, Non-Custom HQH Eye, artificial, custom. 886.3200 Eye Prosthetics Of Utah, Inc. Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Eye Prosthetics Of Wisconsin, Inc. Eye, Artificial, Non-Custom HQH Custom artificial eyes. 886.3200 Eye Restoration Clinic Eye, Artificial, Non-Custom HQH Custom ocular prosthesis. 886.3200 Fort Worth Eye Prosthetics, Inc.

Source: MDRWeb.com 49 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Frank Tanaka, Ocularist, Inc. Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Glenn Reams, Ocularist Eye, Artificial, Non-Custom HQH Eye, artificial, non-custom. 886.3200 Henthorn Ocular Prosthetics Eye, Artificial, Non-Custom HQH Artificial eye 886.3200 Indo German Surgical Corp. Eye, Artificial, Non-Custom HQH Eye, artificial, non-custom. 886.3200 Intermountain Ocular Prosthetics, Inc. Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 June R.R. Nichols, Ocularist Ltd. Eye, Artificial, Non-Custom HQH Custom made Artificial eye. 886.3200 L.J. Greiner & Sons, Inc. Eye, Artificial, Non-Custom HQH Artificial eye 886.3200 Leonids Traders Pvt. Ltd. Eye, Artificial, Non-Custom HQH Various types of custom plastic artificial 886.3200 Maloney’s Custom Ocular eyes. Prosthetics, Inc. Eye, Artificial, Non-Custom HQH 886.3200 Midwest Eye Laboratories, Inc. Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Miller Artificial Eye Laboratory, Inc. Eye, Artificial, Non-Custom HQH Prosthesis, eye, internal. 886.3200 Ocu-Labs, Inc. Eye, Artificial, Non-Custom HQH 886.3200 Ocular Prosthetics, Inc. Eye, Artificial, Non-Custom HQH Artificial eye 886.3200 Paul Instruments (India) Eye, Artificial, Non-Custom HQH Artificial eyes (custom made). 886.3200 Rocky Mountain Anaplastology, Inc. Eye, Artificial, Non-Custom HQH Artificial eye (plastic). 886.3200 S.P. Artificial Eye Co. Eye, Artificial, Non-Custom HQH Eye prosthesis. 886.3200 S.W. Florida Prosthetic Clinic Eye, Artificial, Non-Custom HQH Sng prosthetic eye ins. 886.3200 Sng Prosthetic Eye Institute Eye, Artificial, Non-Custom HQH Non-custom artificial eye. 886.3200 Soper Brothers & Associates Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Southwest Artificial Eyes, Inc. Eye, Artificial, Non-Custom HQH Eye, artificial, custom. 886.3200 Steven R. Young Ocularist, Inc. Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Texas Eye Prosthetics Llc Eye, Artificial, Non-Custom HQH Artificial eye, ocular prosthesis. 886.3200 The Eye Concern, Inc. Eye, Artificial, Non-Custom HQH Prosthesis, eye, internal. 886.3200 Thomas Ocular Prosthetics Labs, Inc. Eye, Artificial, Non-Custom HQH Ocular prosthesis/artificial eye. 886.3200 Thompson Ocular Prosthetics, Inc. Eye, Artificial, Non-Custom HQH Artificial eye 886.3200 Tomas L. Ortega Eye, Artificial, Non-Custom HQH Artificial eye. 886.3200 Turntine Ocular Prosthetics, Inc Hemostat HRQ Various sizes & styles 878.4800 Amann Medizintechnik Hemostat HRQ Hemostat 878.4800 Banzai Corp. Hemostat HRQ OROSTAT (8% epinephrine) hemostatic 878.4800 Belport Co. Inc., Gingi-Pak solutions. Div. Hemostat HRQ Manual surgical instruments. 878.4800 Cardinal Health, Snowden Pencer Products Hemostat HRQ Same 878.4800 Combined Instruments (Pvt.), Ltd. Hemostat HRQ Various types of hemostats 878.4800 Dcv Instrumente Gmbh Hemostat HRQ Surgical hemostat. 878.4800 Dermatologic Lab & Supply, Inc. Hemostat HRQ Hemostat. 878.4800 Deroyal Surgical - Rose Hill Hemostat HRQ Various models of hemostates 878.4800 Dimeda Instrumente Gmbh Hemostat HRQ Various types of hemostats for orthopedical 878.4800 Friedrich Daniels Gmbh use Hemostat HRQ 878.4800 Gustav Weck Hemostat HRQ Hemostat 878.4800 Haikou City Haifa Foreign Trading & Industrial Co. Hemostat HRQ 878.4800 Hartzell & Son, G.

Source: MDRWeb.com 50 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Hemostat HRQ Complete range of hemostats for 878.4800 Hilbro (Pvt) Ltd. orthopedic surgery Hemostat HRQ Surgicel fibrillar absorbable. 878.4800 Johnson & Johnson Medical Division Of Ethicon, Inc. Hemostat HRQ Various hemostats, disposable 878.4800 Kencap Ltd. Hemostat HRQ Forceps hemostat. 878.4800 Kentron Health Care, Inc. Hemostat HRQ 878.4800 Kmedic Hemostat HRQ Topical AVITENE microfibrillar collagen 878.4800 Medchem Products, Inc. hemostat including preloaded applicators: syringe AVITENE; NeuroAVITENE and ENT AVITENE. ENDO-AVITENE topical AVITENE microfibrillar collagen hemostat in an endoscopic delivery device. Hemostat HRQ 878.4800 Micrins Surgical Instruments, Inc. Hemostat HRQ Bone hemostat 878.4800 Nagashima Medical Instruments Co., Ltd. Hemostat HRQ Hemostat 878.4800 Pan Surgical Hemostat HRQ 878.4800 Pocket Nurse Enterprises, Inc. Hemostat HRQ 878.4800 Pollak Ltd. Hemostat HRQ Various types of hemostatic forceps. 878.4800 Precision Surgical Intl., Inc. Hemostat HRQ 878.4800 Prosurge Instruments, Inc. Hemostat HRQ Hemostat 878.4800 Silver Plus Corp. Hemostat HRQ 878.4800 Smith & Nephew Inc.- Orthopaedics Division Hemostat HRQ Manual surgical instrument for general use. 878.4800 Symmetry Medical Usa, Inc. Hemostat HRQ 878.4800 Trans American Medical / Tamsco Instruments Hemostat HRQ 878.4800 Tuzik Boston Hemostat HRQ Hemostat 878.4800 Ultimed Medizintechnik Hemostat HRQ Various 878.4800 Vehu Medical Instrumente Gmbh Hemostat HRQ 878.4800 Zimmer Holdings, Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 A. Hussain Surgical Corp. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 A.T. Medical Gmbh Scissors, Orthopedic, Surgical HRR Various 888.4540 Able Brothers Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Al.Noor Corp. Scissors, Orthopedic, Surgical HRR Scissors. 888.4540 Arthrex California, Inc. Scissors, Orthopedic, Surgical HRR Various types of scissors. 888.4540 Biomet Microfixation Inc. Scissors, Orthopedic, Surgical HRR Various types of orthopedic scissors. 888.4540 Biomet, Inc. Scissors, Orthopedic, Surgical HRR Various types of scissors 888.4540 Bontempi Chirurgische Instrumente Ohg Scissors, Orthopedic, Surgical HRR Same 888.4540 Combined Instruments (Pvt.), Ltd. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Dar Expo Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Defoe Intl. Scissors, Orthopedic, Surgical HRR 888.4540 Deknatel Snowden-Pencer Scissors, Orthopedic, Surgical HRR Dental scissors. 888.4540 Dental Usa, Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Dewal Surgical Co. Scissors, Orthopedic, Surgical HRR Various models of scissors 888.4540 Dimeda Instrumente Gmbh Scissors, Orthopedic, Surgical HRR 888.4540 DJO Inc. Scissors, Orthopedic, Surgical HRR 888.4540 Elmed, Inc. Scissors, Orthopedic, Surgical HRR Various sizes and styles of orthopedic scissors 888.4540 Endura Industries Scissors, Orthopedic, Surgical HRR Various 888.4540 Etablissements Boutmy S.A. Scissors, Orthopedic, Surgical HRR Scissor 888.4540 Euro-Medical Gmbh

Source: MDRWeb.com 51 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Scissors, Orthopedic, Surgical HRR Scissors, orthopedic 888.4540 Everlast Surgical Co. Scissors, Orthopedic, Surgical HRR Various types of scissors 888.4540 Gebrueder Zepf Scissors, Orthopedic, Surgical HRR 888.4540 George Tiemann & Co. Scissors, Orthopedic, Surgical HRR Various 888.4540 Gogi Ent. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Haikou City Haifa Foreign Trading & Industrial Co. Scissors, Orthopedic, Surgical HRR Various types of scissors, orthopedic 888.4540 Hgr Instrumente Gmbh Scissors, Orthopedic, Surgical HRR 888.4540 Hipp Gmbh, Anton Scissors, Orthopedic, Surgical HRR Various types and sizes of scissors 888.4540 Hobri Intl. Scissors, Orthopedic, Surgical HRR Various 888.4540 Huaiyin Medical Instruments Factory Scissors, Orthopedic, Surgical HRR 888.4540 J. Jamner Surgical Instruments, Inc Scissors, Orthopedic, Surgical HRR For arthroscopy use. 888.4540 Karl Storz Endoscopy- America Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Kawality Manufacturing Co. Scissors, Orthopedic, Surgical HRR Orthopedic scissors. 888.4540 Kenad Sg Medical, Inc. Scissors, Orthopedic, Surgical HRR Bandage scissors. 888.4540 Kentron Health Care, Inc. Scissors, Orthopedic, Surgical HRR 888.4540 Kmedic Scissors, Orthopedic, Surgical HRR Surgical scissors 888.4540 M.A.Arain & Brothers (Pvt), Ltd. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 M/S. Perfectra Instruments Scissors, Orthopedic, Surgical HRR 888.4540 Mahe International Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Medicate Industries Scissors, Orthopedic, Surgical HRR 888.4540 Medicon Eg Scissors, Orthopedic, Surgical HRR Various orthopedic surgical scissors,sterile. 888.4540 Medisiss Scissors, Orthopedic, Surgical HRR Multiple (scissors). 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Scissors, Orthopedic, Surgical HRR Multiple (scissors). 888.4540 Medtronic Sofamor Danek Usa, Inc. Scissors, Orthopedic, Surgical HRR 888.4540 Merlyn Pharmaceuticals, Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Microma Medizintechnik Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Pak Axis Intl. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Pamexland International Scissors, Orthopedic, Surgical HRR Panorama intl. 888.4540 Panorama Intl. Scissors, Orthopedic, Surgical HRR Various 888.4540 Passau Impex Scissors, Orthopedic, Surgical HRR Various types of sicissors and cast spreaders. 888.4540 Patterson Medical Supply, Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Pleasant Surgico Scissors, Orthopedic, Surgical HRR 888.4540 Princeton Medical Group, Inc. Scissors, Orthopedic, Surgical HRR 888.4540 Prosurge Instruments, Inc. Scissors, Orthopedic, Surgical HRR 888.4540 Ruettgers Gmbh & Co. Kg, Otto Scissors, Orthopedic, Surgical HRR Scissor, various sizes 888.4540 Rz Medizintechnik Gmbh Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Saqalain Intl. Scissors, Orthopedic, Surgical HRR 888.4540 Scanlan International, Inc. Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Sgs Export Intl. Scissors, Orthopedic, Surgical HRR 888.4540 Siema- Siegfried Martin Gmbh Scissors, Orthopedic, Surgical HRR 888.4540 Smith & Nephew Inc.- Orthopaedics Division Scissors, Orthopedic, Surgical HRR 888.4540 Smith & Nephew, Inc., Endoscopy Division Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Solatch International

Source: MDRWeb.com 52 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Scissors, Orthopedic, Surgical HRR Various 888.4540 Stille Surgical Ab Scissors, Orthopedic, Surgical HRR 888.4540 Storz Gmbh & Co., Karl Scissors, Orthopedic, Surgical HRR Scissors 888.4540 Sufal Industries (Pvt) Ltd. Scissors, Orthopedic, Surgical HRR 888.4540 Symmetry Tnco Scissors, Orthopedic, Surgical HRR 888.4540 Tecno Instruments (Pvt) Ltd. Scissors, Orthopedic, Surgical HRR 888.4540 Teufel Gmbh & Co., Carl Scissors, Orthopedic, Surgical HRR 888.4540 Tuzik Boston Scissors, Orthopedic, Surgical HRR 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Scissors, Orthopedic, Surgical HRR Multiple (scissors). 888.4540 Warsaw Orthopedic, Inc. Scissors, Orthopedic, Surgical HRR Multiple 888.4540 Xavier Ent. Scissors, Orthopedic, Surgical HRR 888.4540 Zimmer Holdings, Inc. Stripper, Surgical HRT Various types of strippers. 888.4540 Biomet Microfixation Inc. Stripper, Surgical HRT Bunnell tendon stripper. 888.4540 Biomet, Inc. Stripper, Surgical HRT Various. 888.4540 Depuy-Raynham, A Div. Of Depuy Orthopaedics Stripper, Surgical HRT M.826 tendon stripper 888.4540 Etablissements Boutmy S.A. Stripper, Surgical HRT Stripper, surgical 888.4540 Hermann Mueller Stripper, Surgical HRT Tendon strippers. 888.4540 King Tool, Inc. Stripper, Surgical HRT 888.4540 Smith & Nephew Inc.- Orthopaedics Division Stripper, Surgical HRT Various 888.4540 Stille Surgical Ab Stripper, Surgical HRT Tendon stripper. 888.4540 Warsaw Orthopedic, Inc. Stripper, Surgical HRT 888.4540 Witte Gmbh Stripper, Surgical HRT 888.4540 Zimmer Holdings, Inc. Dynamometer, Non-Powered HRW Dmg250, eg250-m muscle strength 888.1250 Ametek dynamometer. Dynamometer, Non-Powered HRW Bulb dynamometer. 888.1250 Christy Manufacturing Corp. Dynamometer, Non-Powered HRW For isometric muscle stregth testing and job 888.1250 Elis - Electronic Instruments & task analysis Systems S.R.L. Dynamometer, Non-Powered HRW Non-powered dynamometer. 888.1250 Fabrication Enterprises Inc. Dynamometer, Non-Powered HRW Tongue strengh measuring device. 888.1250 Iopi Northwest Company, Llc Dynamometer, Non-Powered HRW Pressure Stimulus Device. Commander 888.1250 JTECH Medical Algometer measures pressure applied by examiner to elicit a response for pain tolerance, pain threshold and trigger point tenderness. Dynamometer, Non-Powered HRW Various types of dynamometers. 888.1250 Jtech Medical Dynamometer, Non-Powered HRW Dynamometer. 888.1250 Richardson Products, Inc. Dynamometer, Non-Powered HRW 888.1250 Tuzik Boston Dynamometer, Non-Powered HRW Cks patella peg stop drill. 888.1250 Zimmer Trabecular Metal Technology Saw HSO Round single wire toothed saw blade (Gigli) 878.4800 Bestway Products Co. for trauma, neuro, and orthopedic surgery. Saw HSO Various types of sterile and non-sterile 878.4800 Biomet, Inc. orthopedic saws. Saw HSO Same 878.4800 Combined Instruments (Pvt.), Ltd. Saw HSO 878.4800 Dynamic Surgical (Pvt.) Ltd. Saw HSO 878.4800 Elmed, Inc. Saw HSO Various 878.4800 Etablissements Boutmy S.A. Saw HSO Various types of saws, surgical, orthopedic 878.4800 Hgr Instrumente Gmbh Saw HSO 878.4800 Kmedic Saw HSO Dental instruments 878.4800 M.A.Arain & Brothers (Pvt), Ltd.

Source: MDRWeb.com 53 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Saw HSO Various 878.4800 Medical Implanta Medizintechnik Gmbh Saw HSO 878.4800 Merlyn Pharmaceuticals, Inc. Saw HSO No common name listed 878.4800 Nsr Comercio E Representacoes Ltda Saw HSO Gigli wire saws and handles 878.4800 Seifring - Instrumente Gmbh. Saw HSO Various 878.4800 Stille Surgical Ab Saw HSO 878.4800 Stryker Corp. Saw HSO 878.4800 Stryker Spine Saw HSO 878.4800 Tuzik Boston Saw HSO Various bone saws. 878.4800 Warsaw Orthopedic, Inc. Saw HSO 878.4800 Zimmer Holdings, Inc. Splint, Traction HSP Buck’s traction. 888.5890 A&A Orthopedics, Incorporated Splint, Traction HSP 888.5890 Armstrong Medical Industries, Inc. Splint, Traction HSP Various types of traction splints. 888.5890 Biomet, Inc. Splint, Traction HSP Bucks traction boot. 888.5890 Bird & Cronin, Inc. Splint, Traction HSP Various 888.5890 Deltai Medical & Health Articles (Suzhou) Co., Ltd Splint, Traction HSP 888.5890 Deroyal Industries, Inc. Splint, Traction HSP 888.5890 DJO Inc. Splint, Traction HSP 888.5890 Duro-Med Industries Splint, Traction HSP Kendrick traction device. 888.5890 Emergency Products And Research Splint, Traction HSP Traction leg splint. 888.5890 Faretec, Inc. Splint, Traction HSP SPEEDSPLINT Femoral traction speedsplint 888.5890 Geen Healthcare Inc. kit. Splint, Traction HSP Iqs integrated quick splint. 888.5890 Lots Corp. Splint, Traction HSP $352.00 model INF-300 infant SAGER 888.5890 Minto R&D, Inc. bilateral splint, $289.00 model S-301 SAGER FORM III single splint, $436.00 model S-304 SAGER FORM III bilateral splint. Splint, Traction HSP 888.5890 Mizuho Osi Splint, Traction HSP 888.5890 Paramedical Distributors Splint, Traction HSP 888.5890 Patterson Medical Holdings, Inc. Splint, Traction HSP Head halter. 888.5890 Patterson Medical Supply, Inc. Splint, Traction HSP $239.00 list price. 888.5890 Reel R&D, Inc. Splint, Traction HSP Various models of splints. 888.5890 Rk Froom & Co., Inc. Splint, Traction HSP Skin traction kit 888.5890 Smith And Nephew Medical Ltd. Splint, Traction HSP 888.5890 Tetra Medical Supply Corp. Splint, Traction HSP 888.5890 Texas Medical Industries, Inc. Splint, Traction HSP 888.5890 Truform Orthotics & Prosthetics Splint, Traction HSP No common name listed 888.5890 Vision Instruments Ltd. Splint, Traction HSP Aeroplane splint. 888.5890 Warsaw Orthopedic, Inc. Splint, Traction HSP 888.5890 Zimmer Holdings, Inc. Splint, Traction HSP 888.5890 Zimmer Orthopaedic Surgical Products Belt, Pelvic, Traction HSQ Pelvic traction set?. 888.5890 A&A Orthopedics, Incorporated Belt, Pelvic, Traction HSQ 888.5890 Accelerated Care Plus Corp.

Source: MDRWeb.com 54 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Belt, Pelvic, Traction HSQ Pelvic belt. 888.5890 American Orthopedic Supply Co., Inc. Belt, Pelvic, Traction HSQ Various types of pelvic traction belt. 888.5890 Biomet, Inc. Belt, Pelvic, Traction HSQ Pelvic traction belt. 888.5890 Bird & Cronin, Inc. Belt, Pelvic, Traction HSQ Universal size. 888.5890 Chattanooga Group Belt, Pelvic, Traction HSQ Orthopedic belt available. 888.5890 Core Products International, Inc. Belt, Pelvic, Traction HSQ 888.5890 Deroyal Industries, Inc. Belt, Pelvic, Traction HSQ Pelvic traction belts 888.5890 Dj Orthopedics De Mexico, S.A. De C.V. Belt, Pelvic, Traction HSQ 888.5890 DJO Inc. Belt, Pelvic, Traction HSQ Transducer/fetal monitor belt. 888.5890 Elastic Corporation Of America Belt, Pelvic, Traction HSQ 888.5890 Freeman Manufacturing Company Belt, Pelvic, Traction HSQ Single or double pull, size 48-64in., cat. no. 888.5890 Hospital Marketing Svcs. 7345. Company, Inc. Belt, Pelvic, Traction HSQ MOR-LOC. 888.5890 Jobri Llc Belt, Pelvic, Traction HSQ Pelvic traction belt. 888.5890 Kenad Sg Medical, Inc. Belt, Pelvic, Traction HSQ 888.5890 Larkotex Company Belt, Pelvic, Traction HSQ 888.5890 Lohmann & Rauscher, Inc. Belt, Pelvic, Traction HSQ DBS a dynamic brace an optional 888.5890 Meditrac Medical Equipment component can be added to the Ltd. Vertetrac for the treatment of Idiopathic, juevenile,adolescent , and adult Scoliosis Belt, Pelvic, Traction HSQ 888.5890 Mizuho Osi Belt, Pelvic, Traction HSQ Pneumatic Bracing 888.5890 Orthofix Inc. Belt, Pelvic, Traction HSQ 888.5890 Paramedical Distributors Belt, Pelvic, Traction HSQ 888.5890 Patterson Medical Holdings, Inc. Belt, Pelvic, Traction HSQ 888.5890 Professional Products, Inc. Belt, Pelvic, Traction HSQ Various types of pelvic traction belts. 888.5890 Scott Specialties, Inc. Belt, Pelvic, Traction HSQ DURAFOAM. 888.5890 Scott Specialties, Inc./Cmo Inc./Ginny Inc. Belt, Pelvic, Traction HSQ Single pull traction belts. 888.5890 Shamrock Medical, Inc. Belt, Pelvic, Traction HSQ $145.00 per 10 (med). 888.5890 Tartan Orthopedics, Ltd. Belt, Pelvic, Traction HSQ 888.5890 Tetra Medical Supply Corp. Belt, Pelvic, Traction HSQ 888.5890 Texas Medical Industries, Inc. Belt, Pelvic, Traction HSQ Various types of belts for pelvic traction. 888.5890 Texas Orthopaedic Products & Services, L.L.C. Belt, Pelvic, Traction HSQ Various types of pelvic traction. 888.5890 Three-D Orthopedic, Div. Deroyal Industries, Inc. Belt, Pelvic, Traction HSQ 888.5890 Truform Orthotics & Prosthetics Belt, Pelvic, Traction HSQ Universal pelvic belt. 888.5890 Val Med Belt, Pelvic, Traction HSQ Various types of pelvic traction belts. 888.5890 Warsaw Orthopedic, Inc. Belt, Pelvic, Traction HSQ 888.5890 Zimmer Holdings, Inc. Belt, Pelvic, Traction HSQ 888.5890 Zimmer Orthopaedic Surgical Products Unit Traction, Hip, Non-Powered, Non- HSR Various types of non-powered, non- 888.5890 Biomet, Inc. Penetrating penetrating hip traction units. Unit Traction, Hip, Non-Powered, Non- HSR 888.5890 Depuy Ace, A Johnson & Penetrating Johnson Company Unit Traction, Hip, Non-Powered, Non- HSR 888.5890 Truform Orthotics & Penetrating Prosthetics Halter, Head, Traction HSS Cervical traction kit. 888.5890 3M Company Halter, Head, Traction HSS 888.5890 Accelerated Care Plus Corp.

Source: MDRWeb.com 55 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Halter, Head, Traction HSS 888.5890 Alimed, Inc. Halter, Head, Traction HSS Head halter. 888.5890 American Orthopedic Supply Co., Inc. Halter, Head, Traction HSS Various types of halters, head, traction. 888.5890 Biomet, Inc. Halter, Head, Traction HSS 888.5890 Border Opportunity Saver Systems, Inc. Halter, Head, Traction HSS OTHOPEDIC SLINGS 888.5890 Central New York Medical Products Halter, Head, Traction HSS TXA-1 traction accessory package. 888.5890 Chattanooga Group Halter, Head, Traction HSS Various 888.5890 Deltai Medical & Health Articles (Suzhou) Co., Ltd Halter, Head, Traction HSS Various models of halters,head,traction 888.5890 Dimeda Instrumente Gmbh Halter, Head, Traction HSS 888.5890 Florida Manufacturing Corp. Halter, Head, Traction HSS 888.5890 Freeman Manufacturing Company Halter, Head, Traction HSS 888.5890 Larkotex Company Halter, Head, Traction HSS 888.5890 Lohmann & Rauscher, Inc. Halter, Head, Traction HSS Full line 888.5890 Mizuho Osi Halter, Head, Traction HSS 888.5890 Paramedical Distributors Halter, Head, Traction HSS Various types of head halters. 888.5890 Scott Specialties, Inc. Halter, Head, Traction HSS 888.5890 Smith & Nephew Inc.- Orthopaedics Division Halter, Head, Traction HSS 888.5890 Tetra Medical Supply Corp. Halter, Head, Traction HSS Head halter. 888.5890 The Saunders Group Halter, Head, Traction HSS Various types of head halters. 888.5890 Three-D Orthopedic, Div. Deroyal Industries, Inc. Halter, Head, Traction HSS Head halter. 888.5890 Vmg Medical, Inc. Halter, Head, Traction HSS 888.5890 Zimmer Holdings, Inc. Halter, Head, Traction HSS ZIMCODE. 888.5890 Zimmer Orthopaedic Surgical Products Apparatus, Traction, Non-Powered HST MULTIPLE 888.5850 3M Company Apparatus, Traction, Non-Powered HST Accessories, frame, cord, etcc... 888.5850 A&A Orthopedics, Incorporated Apparatus, Traction, Non-Powered HST 888.5850 A.M.G. Medical, Inc. Apparatus, Traction, Non-Powered HST Apparatus, traction, non-powered. 888.5850 Arc Surgical Llc. Apparatus, Traction, Non-Powered HST Traction device. 888.5850 Arthrex Manufacturing Apparatus, Traction, Non-Powered HST Shoulder holder. 888.5850 Arthrex, Inc. Apparatus, Traction, Non-Powered HST A non-powered orthopedic traction 888.5850 Back Bubble apparatus. Apparatus, Traction, Non-Powered HST THE ANGLE lumbar traction unit is priced 888.5850 Back Support Systems from $34.95 and comes in two sizes. THE CURVE lumbar traction unit is priced at $119.95. Apparatus, Traction, Non-Powered HST Pelvic traction unit. 888.5850 Bagrad Apparatus, Traction, Non-Powered HST Various types of traction (cart, reame, cord, 888.5850 Biomet, Inc. weight) accessories. Apparatus, Traction, Non-Powered HST Various traction kits and accessories. 888.5850 Bird & Cronin, Inc. Apparatus, Traction, Non-Powered HST Arm traction device. 888.5850 Breg, Inc., An Orthofix Company Apparatus, Traction, Non-Powered HST 888.5850 Brenner Metal Products Apparatus, Traction, Non-Powered HST Splint. 888.5850 Carpal Doctors Llc Apparatus, Traction, Non-Powered HST 888.5850 Core Products International, Inc. Apparatus, Traction, Non-Powered HST Cervical traction devices. 888.5850 Depuy Mitek, Inc. Apparatus, Traction, Non-Powered HST Various types of non-powered tration 888.5850 Depuy Orthopaedics, Inc. apparatus.

Source: MDRWeb.com 56 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Apparatus, Traction, Non-Powered HST Traction accessories 888.5850 Dj Orthopedics De Mexico, S.A. De C.V. Apparatus, Traction, Non-Powered HST Overdoor traction set. 888.5850 Dynatronics Corp. Chattanooga Operations Apparatus, Traction, Non-Powered HST Spring drum traction system 888.5850 Economic Holland B.V. Apparatus, Traction, Non-Powered HST Pord device 888.5850 Efratgo, Ltd. Hi Tech Bio- Surgical Apparatus, Traction, Non-Powered HST Hand wheel. 888.5850 Elite Medical Equipment Apparatus, Traction, Non-Powered HST Vertican Traction System is a non-powered 888.5850 Endorphin Corporation traction device for treating back pain in both the lumbar region and the cervical region. It can utilize focused traction to treat spondylolisthesis, retrolisthesis and other problems associated with the lumbar sp Apparatus, Traction, Non-Powered HST Traction weights. 888.5850 Faretec, Inc. Apparatus, Traction, Non-Powered HST Apparatus, traction, non-powered. 888.5850 Gilliam Enterprises, Llc Apparatus, Traction, Non-Powered HST PRONEX is a patient controlled pneumatic 888.5850 Glacier Cross, Inc. cervical traction device. HOMESTRETCH is a patient controlled pneumatic lumbar traction device. Apparatus, Traction, Non-Powered HST Adaptors. 888.5850 Hill-Rom, Inc. Apparatus, Traction, Non-Powered HST Knee extension device. 888.5850 Ihn, Inc. Apparatus, Traction, Non-Powered HST Back strecher and massager 888.5850 Immunomed, Llc Apparatus, Traction, Non-Powered HST 888.5850 Instrumentarium Corp. Instrumed Division Apparatus, Traction, Non-Powered HST BED TRACTION UNIT; POSEY WEIGHTS 888.5850 J. T. Posey Co. Apparatus, Traction, Non-Powered HST Apparatus, traction, non-powered. 888.5850 Kenshin Trading Corp. Apparatus, Traction, Non-Powered HST 888.5850 Lohmann & Rauscher, Inc. Apparatus, Traction, Non-Powered HST Traction equipment. 888.5850 Malcomtech International Apparatus, Traction, Non-Powered HST Carts, frames, weight, cords. 888.5850 Medical Depot Apparatus, Traction, Non-Powered HST Leg holder with integrated tourniquet. 888.5850 Mictron, Inc. Apparatus, Traction, Non-Powered HST Arch attachment, shrp traction attachment. 888.5850 Midwest Health Care Consultants Inc. Apparatus, Traction, Non-Powered HST $249 for SPINALAID (3’x2’x7’) back traction 888.5850 Physical Research Company system, $145 for cervical & thoracic bench. Apparatus, Traction, Non-Powered HST 888.5850 Posture Pro, Inc. Apparatus, Traction, Non-Powered HST Ruch carpal tunnel glove. 888.5850 Preeminent, Llc Apparatus, Traction, Non-Powered HST Shoulder suspension system. 888.5850 Promedica, Inc. Apparatus, Traction, Non-Powered HST Traction apparatus. 888.5850 Pro-Zooics Research Associates Apparatus, Traction, Non-Powered HST Pronex 888.5850 Rs Medical Apparatus, Traction, Non-Powered HST 888.5850 Serola Biomechanics, Inc. Apparatus, Traction, Non-Powered HST Lumbar and supine cervical traction system 888.5850 Shamrock Medical, Inc. for home or clinical use. Apparatus, Traction, Non-Powered HST 888.5850 Smith & Nephew Inc.- Orthopaedics Division Apparatus, Traction, Non-Powered HST Hip distraction system,hardware. 888.5850 Smith & Nephew Inc., Endoscopy Div. Apparatus, Traction, Non-Powered HST Lumbar rehabilitation system. 888.5850 Spinal Designs Intl. Apparatus, Traction, Non-Powered HST Ambulatory. 888.5850 Spinal Traction Products, Llc. Apparatus, Traction, Non-Powered HST Various types and sizes of non-powered 888.5850 Synthes (Usa) traction components. Apparatus, Traction, Non-Powered HST Cervical traction. 888.5850 The Pettibon System Apparatus, Traction, Non-Powered HST Cervical traction device. 888.5850 The Saunders Group Apparatus, Traction, Non-Powered HST Knee extension board. 888.5850 Top Shelf Manufacturing, Llc Apparatus, Traction, Non-Powered HST Orthopedic traction device. 888.5850 Total Motion Restoration, Llc

Source: MDRWeb.com 57 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Apparatus, Traction, Non-Powered HST 888.5850 Truform Orthotics & Prosthetics Apparatus, Traction, Non-Powered HST Traction stand. 888.5850 Tubular Fabricators Industry, Inc. Apparatus, Traction, Non-Powered HST Traction device. 888.5850 Vmg Medical, Inc. Apparatus, Traction, Non-Powered HST Various types of weights, cord, frames, and 888.5850 Warsaw Orthopedic, Inc. other traction acc. Pliers, Surgical HTC Various types of surgical pliers. 878.4800 Beere Precision Medical Instruments, Kmedic, Telef Pliers, Surgical HTC Various types of pliers. 878.4800 Biomet Microfixation Inc. Pliers, Surgical HTC Various types of surgical pliers. 878.4800 Biomet, Inc. Pliers, Surgical HTC Various types of surgical pliers 878.4800 Bontempi Chirurgische Instrumente Ohg Pliers, Surgical HTC Various 878.4800 Chifa Pliers, Surgical HTC Various 878.4800 Christian Diener Gmbh. & Co. K.G. Pliers, Surgical HTC Same 878.4800 Combined Instruments (Pvt.), Ltd. Pliers, Surgical HTC Various types of surgical pliers 878.4800 Dcv Instrumente Gmbh Pliers, Surgical HTC Dental pliers. 878.4800 Dental Usa, Inc. Pliers, Surgical HTC Spinal rod holder. 878.4800 Depuy Spine, Inc. Pliers, Surgical HTC Various 878.4800 Diwymed Production Gmbh Pliers, Surgical HTC 878.4800 Elmed, Inc. Pliers, Surgical HTC Suture pliers. 878.4800 H & H Co. Pliers, Surgical HTC 878.4800 Holmed Corporation Pliers, Surgical HTC Pliers, surgical 878.4800 K.K. Metallic Industries Pliers, Surgical HTC Pin and wire cutting pliers with TC inserts. 878.4800 Kapp Chirurgische Instrumente Gmbh Pliers, Surgical HTC Various types of plier, surgical orthopedic 878.4800 Kashmir Surgical Co. Pliers, Surgical HTC Stainless steel pliers. 878.4800 Key Surgical, Inc. Pliers, Surgical HTC 878.4800 Kmedic Pliers, Surgical HTC Pliers 878.4800 Lang Medizintechnik Pliers, Surgical HTC Multiple pliers, surgical. 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Pliers, Surgical HTC Multiple pliers, surgical. 878.4800 Medtronic Sofamor Danek Usa, Inc. Pliers, Surgical HTC Various 878.4800 Michele Cannova Chirurgische Instrumente Pliers, Surgical HTC Various types of pliers, orthopedic 878.4800 Normed Gmbh Pliers, Surgical HTC Panorama intl. 878.4800 Panorama Intl. Pliers, Surgical HTC 878.4800 Prosurge Instruments, Inc. Pliers, Surgical HTC Various 878.4800 Rainer Rosenkranz Chirurgische Instrumente Manufac Pliers, Surgical HTC No common name listed 878.4800 Schad Medical Instruments Gmbh Pliers, Surgical HTC Pliers, surgical. 878.4800 Small Bone Innovations, Inc. Pliers, Surgical HTC 878.4800 Smith & Nephew Inc.- Orthopaedics Division Pliers, Surgical HTC Pliers 878.4800 Smt Schilling Metalltechnik Gmbh Pliers, Surgical HTC Vacuum powered tweezer, needle guide. 878.4800 Standard Imaging, Inc. Pliers, Surgical HTC Manual surgical instrument for general use. 878.4800 Symmetry Medical Usa, Inc. Pliers, Surgical HTC Floor and medium grade surgical stainless 878.4800 Trans American Medical / steel. Tamsco Instruments Pliers, Surgical HTC Multiple pliers, surgical. 878.4800 Warsaw Orthopedic, Inc.

Source: MDRWeb.com 58 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Pliers, Surgical HTC 878.4800 Zimmer Holdings, Inc. Forceps HTD Forceps. 878.4800 Abbott Spine, Inc. Forceps HTD Various 878.4800 Able Brothers Forceps HTD Forceps 878.4800 Al.Noor Corp. Forceps HTD Foldable and implantation forceps. 878.4800 American Surgical Instrument Corp. Forceps HTD All types. 878.4800 Arista Surgical Supply Co. Inc. Forceps HTD Grasper/forceps. 878.4800 Arthrex California, Inc. Forceps HTD Various types of forceps. 878.4800 Biomet Microfixation Inc. Forceps HTD Hand instruments. 878.4800 Biomet Sports Medicine, Inc Forceps HTD Various types of orthopedic forceps. 878.4800 Biomet, Inc. Forceps HTD Ophthalmic; vascular/cardiovascular; ENT, 878.4800 Boss Instruments, Ltd. plastic surgery; neurosurgical, orthopedic, micro surgery, general surgery. Forceps HTD Sterile/non-sterile, plastic disposable 878.4800 Busse Hospital Disposables, forceps. Inc. Forceps HTD 878.4800 Carl Heyer, Inc. Forceps HTD 878.4800 Chandjee Manufacturing Co. Forceps HTD Various 878.4800 Christian Diener Gmbh. & Co. K.G. Forceps HTD Various type of surgical instruments general 878.4800 Cm-Instrumente & plastic surgery Vertriebsgesellschaftmbh Forceps HTD 878.4800 Cml Consortium De Materiel Pour Lab. Forceps HTD Same 878.4800 Combined Instruments (Pvt.), Ltd. Forceps HTD Forceps. 878.4800 Conformis, Inc. Forceps HTD Forceps 878.4800 Conquerer Surgical Forceps HTD Various grasping and retrieval forceps, 878.4800 Cook Endoscopy soehendra stent retriever. Forceps HTD Replacement mouth pieces for forceps 878.4800 Dannoritzer Medical Instruments Forceps HTD Forceps 878.4800 Defoe Intl. Forceps HTD 878.4800 Deknatel Snowden-Pencer Forceps HTD 878.4800 Denovo Dental, Inc. Forceps HTD Dental forceps. 878.4800 Dental Usa, Inc. Forceps HTD Forceps. 878.4800 Depuy Spine, Inc. Forceps HTD Surgical forceps. 878.4800 Dermatologic Lab & Supply, Inc. Forceps HTD Forceps. 878.4800 Deroyal Surgical - Rose Hill Forceps HTD Forceps 878.4800 Dewal Surgical Co. Forceps HTD Various 878.4800 Dimeda Instrumente Gmbh Forceps HTD Various 878.4800 Diwymed Production Gmbh Forceps HTD 878.4800 DJO Inc. Forceps HTD 878.4800 Endoscopy Support Services, Inc. Forceps HTD Various 878.4800 Etablissements Boutmy S.A. Forceps HTD 878.4800 Fehling Surgical Instruments Forceps HTD 878.4800 Fortrad Eye Instruments Corp. Forceps HTD Various sizes of orthopedie forceps 878.4800 Franz Maier Chir. Instrumente Forceps HTD Self-retaining forceps, bone holding, 878.4800 Friedrich Daniels Gmbh verbrugge, kern-holding Forceps HTD Ligature passing forceps 878.4800 G.U. Medical Ltd. Forceps HTD Various types of forceps 878.4800 Gebrueder Zepf

Source: MDRWeb.com 59 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Forceps HTD Orthopedic forceps and instruments for 878.4800 George Tiemann & Co. mandibular joint surgery. Forceps HTD Multiple 878.4800 Ghazi Bros. Surgical Co. Forceps HTD Various 878.4800 Gogi Ent. Forceps HTD 878.4800 Gustav Weck Forceps HTD Forceps, surgical, all types. 878.4800 H & H Co. Forceps HTD 878.4800 Harvard Apparatus, Inc. Forceps HTD Forceps, tweezers. 878.4800 Healer Products, Llc Forceps HTD Various types of forceps. 878.4800 Health Care Logistics, Inc. Forceps HTD Thumb, Ring, etc. 878.4800 Hilbro (Pvt) Ltd. Forceps HTD Various types and sizes of forceps 878.4800 Hobri Intl. Forceps HTD Various 878.4800 Huaiyin Medical Instruments Factory Forceps HTD 878.4800 J. Jamner Surgical Instruments, Inc Forceps HTD Forceps. 878.4800 K. W. Griffen Co. Forceps HTD Various 878.4800 K.K. Metallic Industries Forceps HTD 878.4800 Kapp Chirurgische Instrumente Gmbh Forceps HTD 878.4800 Karl Storz Endoscopy- America Inc. Forceps HTD Various 878.4800 Kashmir Surgical Co. Forceps HTD Forceps 878.4800 Kawality Manufacturing Co. Forceps HTD Various forceps, disposable 878.4800 Kencap Ltd. Forceps HTD Forceps. 878.4800 Kentron Health Care, Inc. Forceps HTD Disposable. 878.4800 Kenyon Industries, Inc. Forceps HTD Meniscal suture grabbers. 878.4800 King Tool, Inc. Forceps HTD Bipolar electrosurgical forceps. Non-stick 878.4800 Kirwan Surgical Products, Inc. bipolar forceps. Forceps HTD 878.4800 Kmedic Forceps HTD Various sizes and types of forceps 878.4800 Lanques Medical Forceps HTD Arthroscopy forceps: blunt, scoop, grasper, 878.4800 Lican Medical Products Ltd. scissors and miniature types; also available, thoracic forceps. Forceps HTD Dental instruments/surgical instruments 878.4800 M.A.Arain & Brothers (Pvt), Ltd. Forceps HTD Forceps 878.4800 M/S. Perfectra Instruments Forceps HTD 878.4800 Mahe International Inc. Forceps HTD Pliers, tweezers and forceps for electronic 878.4800 Manufactures D’Outils medical, surgical, microsurgical, industrial, Dumont S. A. biological and cosmetic usages. Forceps HTD Various. 878.4800 Marina Medical Instruments, Inc. Forceps HTD Forceps 878.4800 Medicate Industries Forceps HTD 878.4800 Medicon Eg Forceps HTD Various forceps. 878.4800 Medtronic Puerto Rico Operations Co.,Med Rel Forceps HTD Multiple forceps. 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Forceps HTD Multiple forceps. 878.4800 Medtronic Sofamor Danek Usa, Inc. Forceps HTD Sterile tweezers. 878.4800 Medtronic Spine Llc Forceps HTD 878.4800 Merlyn Pharmaceuticals, Inc. Forceps HTD 878.4800 Musculoskeletal Transplant Foundation Forceps HTD Forceps. 878.4800 Odyssey Medical, Inc.

Source: MDRWeb.com 60 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Forceps HTD Forceps 878.4800 Pak Axis Intl. Forceps HTD Forceps 878.4800 Pamexland International Forceps HTD Forceps 878.4800 Pan Surgical Forceps HTD Panorama intl. 878.4800 Panorama Intl. Forceps HTD Various 878.4800 Passau Impex Forceps HTD Various 878.4800 Peter Hoehnle Forceps HTD Forceps 878.4800 Pleasant Surgico Forceps HTD Disposable. Forceps 4 1/2 in.; deluxe forceps 878.4800 Pollak Ltd. 4 1/2 in.; lift forceps 5 in.; insert molded forceps with stainless steel 5 1/4 in. Forceps HTD 878.4800 Princeton Medical Group, Inc. Forceps HTD 878.4800 Prosurge Instruments, Inc. Forceps HTD Forceps. 878.4800 Qfc Plastics, Inc. Forceps HTD Various 878.4800 R. Schilling Forceps HTD Razoraid-a ingrown hair extricator. 878.4800 Razoraid Incorporated Forceps HTD Forceps 878.4800 Regine Switzerland Forceps HTD Forceps. sterile 878.4800 Ri Mos. S.R.L. Forceps HTD Various 878.4800 Richard Gut Chir. Instrumente Gmbh Forceps HTD Various types of forceps 878.4800 Robert Mueller Instrumente Forceps HTD $43.75 per case of 100 GRIPRITE disposable 878.4800 Rocialle Medical Ltd. dissecting forceps. Forceps HTD 878.4800 Ross Disposable Products Forceps HTD Atrauma forceps, various sizes 878.4800 Rz Medizintechnik Gmbh Forceps HTD Various types of forceps. 878.4800 Salvin Dental Specialties, Inc. Forceps HTD Forceps 878.4800 Saqalain Intl. Forceps HTD Forceps, disposable. 878.4800 Sca Personal Care, North America Forceps HTD 878.4800 Scanlan International, Inc. Forceps HTD 878.4800 Semadeni Ag Forceps HTD Forceps 878.4800 Sgs Export Intl. Forceps HTD Forceps 878.4800 Silver Plus Corp. Forceps HTD GENERAL & PLASTIC SURGERY - SCREW 878.4800 Small Bone Innovations, Inc. HOLDING FORCEPS; REPOSITIONAL FORCEPS Forceps HTD Forceps. 878.4800 Small Bone Innovations, Inc. Forceps HTD 878.4800 Smith & Nephew Inc.- Orthopaedics Division Forceps HTD 878.4800 Smith & Nephew, Inc., Endoscopy Division Forceps HTD Forceps 878.4800 Smt Schilling Metalltechnik Gmbh Forceps HTD Various 878.4800 Solatch International Forceps HTD Forceps. 878.4800 Spine Wave, Inc. Forceps HTD 878.4800 Standard Instrumentation, Div. Preiser Scientific Forceps HTD Surgical and laboratory stainless steel 878.4800 Stern Inc., Walter scissors, forceps, tweezers. Forceps HTD Various 878.4800 Stille Surgical Ab Forceps HTD Various 878.4800 Stoehr Medizintechnik Forceps HTD Various 878.4800 Stone Instruments Co. Forceps HTD 878.4800 Storz Gmbh & Co., Karl Forceps HTD 878.4800 Stryker Spine Forceps HTD Forceps 878.4800 Sufal Industries (Pvt) Ltd.

Source: MDRWeb.com 61 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Forceps HTD Manual surgical instrument for general use. 878.4800 Symmetry Medical Usa, Inc. Forceps HTD Endoscopic forceps. 878.4800 Symmetry Tnco Forceps HTD Forcep. 878.4800 Synovis Micro Companies Alliance, Inc. Forceps HTD Same 878.4800 The Fazex Co. Forceps HTD Floor & medium grade surgical stainless 878.4800 Trans American Medical / steel. Tamsco Instruments Forceps HTD 878.4800 Triboro Supplies Inc Forceps HTD 878.4800 Tuzik Boston Forceps HTD 878.4800 Ulrich Ag Forceps HTD Forceps 878.4800 Ultimed Medizintechnik Forceps HTD Forceps 878.4800 Vehu Medical Instrumente Gmbh Forceps HTD Multiple forceps. 878.4800 Warsaw Orthopedic, Inc. Forceps HTD 878.4800 Wexler Surgical Supplies Forceps HTD Multiple 878.4800 Xavier Ent. Forceps HTD 878.4800 Zimmer Holdings, Inc. Forceps HTD FLEXTIP steerable rongeurs for discectomy. 878.4800 Zimmer Spine Elevator HTE Various 878.4800 Christian Diener Gmbh. & Co. K.G. Elevator HTE 878.4800 Codman & Shurtleff, Inc Elevator HTE Same 878.4800 Combined Instruments (Pvt.), Ltd. Elevator HTE Various sizes/styles of elevators. 878.4800 Depuy Spine, Inc. Elevator HTE 878.4800 Deroyal Industries, Inc. Elevator HTE Various 878.4800 Diwymed Production Gmbh Elevator HTE 878.4800 Dynamic Surgical (Pvt.) Ltd. Elevator HTE 878.4800 Equip For Independence, Inc. Elevator HTE 878.4800 George Tiemann & Co. Elevator HTE 878.4800 Holmed Corporation Elevator HTE Elevator. 878.4800 In’Tech Medical, Incorporated Elevator HTE 878.4800 Kmedic Elevator HTE Cobb, harrington, cushing, langenbeck, 878.4800 Marida, Marianne Daniels adson, key Chir. Instr. Elevator HTE 878.4800 Medicon Eg Elevator HTE Multiple elevators, orthopedic. 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Elevator HTE Multiple elevators, orthopedic. 878.4800 Medtronic Sofamor Danek Usa, Inc. Elevator HTE 878.4800 Musculoskeletal Transplant Foundation Elevator HTE Elevator 878.4800 Rainer Huber Elevator HTE Various 878.4800 Stille Surgical Ab Elevator HTE Same 878.4800 The Fazex Co. Elevator HTE 878.4800 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Elevator HTE Multiple elevators, orthopedic. 878.4800 Warsaw Orthopedic, Inc. Elevator HTE 878.4800 Zimmer Holdings, Inc. Elevator HTE Elevator. 878.4800 Zimmer Spine, Inc. Curette HTF Curette. 878.4800 Abbott Spine, Inc. Curette HTF Curette 878.4800 Anrs Corp. Curette HTF Curette.; MULTIPLE 878.4800 Biomet Microfixation Inc.

Source: MDRWeb.com 62 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Curette HTF Orthopedic curettes. 878.4800 Biomet, Inc. Curette HTF 878.4800 Carl Heyer, Inc. Curette HTF 878.4800 Chandjee Manufacturing Co. Curette HTF Various 878.4800 Christian Diener Gmbh. & Co. K.G. Curette HTF Same 878.4800 Combined Instruments (Pvt.), Ltd. Curette HTF Currette. 878.4800 Covidien Lp, Formerly Registered As United States Surgical Curette HTF Various types of curettes 878.4800 Dcv Instrumente Gmbh Curette HTF Dental curette. 878.4800 Dental Usa, Inc. Curette HTF Various 878.4800 Depuy Ace S.A.’R.L. Curette HTF Various types/sizes of curettes. 878.4800 Depuy Spine, Inc. Curette HTF Surgical curette. 878.4800 Dermatologic Lab & Supply, Inc. Curette HTF Various models of curettes 878.4800 Dimeda Instrumente Gmbh Curette HTF Various 878.4800 Diwymed Production Gmbh Curette HTF 878.4800 DJO Inc. Curette HTF 878.4800 Fehling Surgical Instruments Curette HTF 878.4800 Fortrad Eye Instruments Corp. Curette HTF 878.4800 George Tiemann & Co. Curette HTF Currettes 878.4800 Gogi Ent. Curette HTF Curette, orthopedic 878.4800 Hartmut Willutzki Curette HTF ENDOCYTE (disposable) non-suction 878.4800 Health Supply Company curette, obtains comprehensive sample Inc., The of endometrial tissue for histological examination. Curette HTF 878.4800 Holmed Corporation Curette HTF Curette. 878.4800 Invuity, Inc. Curette HTF 878.4800 Invuity, Inc. Curette HTF Curette/elevator 878.4800 Karl August Huber Curette HTF Disposable. 878.4800 Kartell S.P.A. Curette HTF 878.4800 Kmedic Curette HTF Multiple 878.4800 Lanques Medical Curette HTF Dental instruments 878.4800 M.A.Arain & Brothers (Pvt), Ltd. Curette HTF Currettes 878.4800 M/S. Perfectra Instruments Curette HTF Various. 878.4800 Marina Medical Instruments, Inc. Curette HTF ENDOSAMPLER, disposable curette for 878.4800 Medgyn Products, Inc. sampling the uterine endometrium. Curette HTF Multiple (orthopedic curettes). 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Curette HTF Multiple (orthopedic curettes). 878.4800 Medtronic Sofamor Danek Usa, Inc. Curette HTF $156.20 per box of 25 EXPLORA curettes (3- 878.4800 Milex Products, Inc. mm o.d. and 4-mm o.d.). Curette HTF Various types of orthopedic currettes 878.4800 Nagashima Medical Instruments Co., Ltd. Curette HTF Various types of curettes. 878.4800 Pappas Surgical Instruments, Llc Curette HTF Brun Bone Curettes,set of nine most used 878.4800 Precision Medical sizes, made of stainless steel with hollow Manufacturing Corporation handles tha are hard to bend or come apart from shank of curette.

Source: MDRWeb.com 63 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Curette HTF 878.4800 Pru-Dent Manufacturing Co. Curette HTF Curette 878.4800 Rainer Huber Curette HTF Various types of curette, orthopedic 878.4800 Rudolf Storz Gmbh Curette HTF Ring curette,various sizes 878.4800 Rz Medizintechnik Gmbh Curette HTF Curette 878.4800 Saqalain Intl. Curette HTF Cement. 878.4800 Smith & Nephew Inc.- Orthopaedics Division Curette HTF Ring curette. 878.4800 Spine Wave, Inc. Curette HTF Various 878.4800 Stille Surgical Ab Curette HTF Various. 878.4800 Stryker Instruments, Instruments Div. Curette HTF Manual surgical instrument for general use. 878.4800 Symmetry Medical Usa, Inc. Curette HTF 878.4800 Symmetry Tnco Curette HTF Gynecological. 878.4800 Trans American Medical / Tamsco Instruments Curette HTF 878.4800 Tuzik Boston Curette HTF Surgical curette. 878.4800 Ussc Puerto Rico, Inc. Curette HTF 878.4800 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Curette HTF Multiple (orthopedic curettes). 878.4800 Warsaw Orthopedic, Inc. Curette HTF WHITNEY; small blue plastic curette used 878.4800 Whitney Products, Inc. to remove excess bone cement before implanting prosthetic hip or knee joints. Sterile and disposable. WHITNEY LARGE CURETTE; large yellow plastic curette used to remove excess bone cement before implanting prosth Curette HTF No common name listed 878.4800 Wolfgang Atzrodt Curette HTF 878.4800 Zimmer Holdings, Inc. Curette HTF Curette. 878.4800 Zimmer Spine, Inc. Protractor HTH Protractor for clinical use. 888.4600 Arthrex, Inc. Protractor HTH Pocket protractor. 888.4600 Biomet, Inc. Protractor HTH PCL Pro assists in the measurement of the 888.4600 Medmetric Corp. disrupted PCL $810.00 Protractor HTH 888.4600 Radiation Products Design, Inc. Protractor HTH Multiple 888.4600 S.P.O.R.T. Protractor HTH 888.4600 Zimmer Holdings, Inc. Protractor HTH Extramededullary tibial alignment guide. 888.4600 Zimmer Trabecular Metal Technology Gauge, Depth HTJ Depth gauge. 888.4300 Abbott Spine, Inc. Gauge, Depth HTJ Variuos depth gauges. 888.4300 Arthrex, Inc. Gauge, Depth HTJ Bone screw depth gauge. 888.4300 Biomet, Inc. Gauge, Depth HTJ Gauge, depth 888.4300 Combined Instruments (Pvt.), Ltd. Gauge, Depth HTJ Depth gauge. 888.4300 Covidien Lp, Formerly Registered As United States Surgical Gauge, Depth HTJ Various 888.4300 Depuy Ace S.A.’R.L. Gauge, Depth HTJ Various 888.4300 Depuy France S.A. Gauge, Depth HTJ Depth guage. 888.4300 Depuy Mitek, A Johnson & Johnson Company Gauge, Depth HTJ Various types of depth gauges. 888.4300 Depuy Orthopaedics, Inc. Gauge, Depth HTJ Depth gauge. 888.4300 Depuy Spine, Inc. Gauge, Depth HTJ Various types of depth gauges. 888.4300 Depuy-Raynham, A Div. Of Depuy Orthopaedics Gauge, Depth HTJ Various models of gauges, depth 888.4300 Dimeda Instrumente Gmbh

Source: MDRWeb.com 64 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Gauge, Depth HTJ Various types of depth gages. 888.4300 Interventional Spine, Inc. Gauge, Depth HTJ Defect Sizing Tools 888.4300 Intrinsic Therapeutics Inc. Gauge, Depth HTJ Depth gauge. 888.4300 K2m, Inc. Gauge, Depth HTJ 888.4300 Kls-Martin L.P. Gauge, Depth HTJ 888.4300 Kmedic Gauge, Depth HTJ Multiple (depth gauges). 888.4300 Medtronic Sofamor Danek Instrument Manufacturing Gauge, Depth HTJ Multiple (depth gauges). 888.4300 Medtronic Sofamor Danek Usa, Inc. Gauge, Depth HTJ Sbs” trial spacer. 888.4300 Musculoskeletal Transplant Foundation Gauge, Depth HTJ Various styles of gauge, depth, orthopedic 888.4300 Schad Medical Instruments Gmbh Gauge, Depth HTJ Depth gauge. 888.4300 Small Bone Innovations, Inc. Gauge, Depth HTJ 888.4300 Smith & Nephew Inc.- Orthopaedics Division Gauge, Depth HTJ 888.4300 Smith & Nephew, Inc., Endoscopy Division Gauge, Depth HTJ 888.4300 Stryker Spine Gauge, Depth HTJ Depth gauge. 888.4300 Surgical Implant Generation Network (Sign) Gauge, Depth HTJ Depth gauge for clinical use. 888.4300 Symmetry Medical Usa, Inc. Gauge, Depth HTJ Multiple (depth gauges). 888.4300 Warsaw Orthopedic, Inc. Gauge, Depth HTJ 888.4300 Zimmer Holdings, Inc. Gauge, Depth HTJ Depth gague. 888.4300 Zimmer Spine, Inc. Gauge, Depth HTJ Depth gauge. 888.4300 Zimmer Trabecular Metal Technology Reamer HTO Various sizes coring reamers and related 888.4540 Arthrex, Inc. items. Reamer HTO Reamer. 888.4540 Ascent Healthcare Solutions Reamer HTO Various types of reamers. 888.4540 Biomet, Inc. Reamer HTO FINBLADE. 888.4540 Case Medical, Inc. Reamer HTO Broken prosthesis removal reamer; powered 888.4540 ConMed Linvatec handpiece, trephines & extractors, 250RPM, 100 in/oz torque, also reamer drivers, orthopedic and micro bone reamers. Reamer HTO Various 888.4540 Depuy Ace S.A.’R.L. Reamer HTO Various 888.4540 Depuy France S.A. Reamer HTO Various orthopedic reamers. 888.4540 Depuy Mitek, A Johnson & Johnson Company Reamer HTO Various sizes of surgical orthopaedic 888.4540 Depuy Spine, Inc. reamers. Reamer HTO Various models of reamers 888.4540 Dimeda Instrumente Gmbh Reamer HTO 888.4540 DJO Inc. Reamer HTO Reamer. 888.4540 Elite Medical Equipment Reamer HTO Reamer 888.4540 Forestadent Bernhard Forster Gmbh Reamer HTO Zuelzer awl use 888.4540 Friedrich Daniels Gmbh Reamer HTO Orthopedic. 888.4540 Grace Manufacturing, Inc. Reamer HTO 888.4540 Holmed Corporation Reamer HTO Reamer. 888.4540 K2m, Inc. Reamer HTO Various 888.4540 Medical Implanta Medizintechnik Gmbh Reamer HTO Various reamers,sterile. 888.4540 Medisiss Reamer HTO Multiple (orthopedic reamers). 888.4540 Medtronic Sofamor Danek Instrument Manufacturing

Source: MDRWeb.com 65 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Reamer HTO Multiple (orthopedic reamers). 888.4540 Medtronic Sofamor Danek Usa, Inc. Reamer HTO 888.4540 minSURG International, Inc. Reamer HTO Surgical or prosthetic instrument. 888.4540 Nobel Biocare Usa, Llc Reamer HTO Various sizes of acetabular cup reamers 888.4540 Orthogenesis, Inc. and associated handles. Reamer HTO Reamer. 888.4540 Orthovita, Inc. Reamer HTO 888.4540 Richards Micro-Tool, Inc. Reamer HTO $123.00 each for 8 models - 1.6mm to 8mm 888.4540 Rush-Berivon, Inc. dia., 3-1/2 to 10-3/8in length. Reamer HTO 888.4540 Smith & Nephew Inc.- Orthopaedics Division Reamer HTO 888.4540 Stryker Corp. Reamer HTO 888.4540 Stryker Spine Reamer HTO Reamer.; HAND REAMER 888.4540 Surgical Implant Generation Network (Sign) Reamer HTO Various types and sizes of reamers. 888.4540 Synthes (Usa) Reamer HTO Multiple (orthopedic reamers). 888.4540 Warsaw Orthopedic, Inc. Reamer HTO Retrograde, Trinkle fitting, 7-12mm. 888.4540 Zimmer Holdings, Inc. Reamer HTO Reamer. 888.4540 Zimmer Spine, Inc. Reamer HTO Hip cylindrical reamer. 888.4540 Zimmer Trabecular Metal Technology File HTP Various types of files. 888.4540 Biomet Microfixation Inc. File HTP Orthopedic bone file. 888.4540 Biomet, Inc. File HTP X-ray film files. 888.4540 Carr Corporation File HTP Same 888.4540 Combined Instruments (Pvt.), Ltd. File HTP 888.4540 Elmed, Inc. File HTP 888.4540 Integral Design Inc. File HTP 888.4540 Kmedic File HTP 888.4540 Medicon Eg File HTP 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg File HTP Bone file. 888.4540 Zimmer Trabecular Metal Technology Broach HTQ Various types of broachs. 888.4540 Biomet, Inc. Broach HTQ Various sizes of broaches. 888.4540 Depuy Spine, Inc. Broach HTQ Broach. 888.4540 Small Bone Innovations, Inc. Broach HTQ 888.4540 Smith & Nephew Inc.- Orthopaedics Division Broach HTQ 888.4540 Zimmer Holdings, Inc. Broach HTQ Femoral stem broach. 888.4540 Zimmer Trabecular Metal Technology Rasp HTR Rasp. 878.4800 Abbott Spine, Inc. Rasp HTR Various types of rasps. 878.4800 Biomet Microfixation Inc. Rasp HTR Various types of orthopedic rasps such as 878.4800 Biomet, Inc. moore rasp, thompson rasp, and muller . Rasp HTR 878.4800 ConMed Linvatec Rasp HTR Rasps 878.4800 Dannoritzer Medical Instruments Rasp HTR Various 878.4800 Depuy Ace S.A.’R.L. Rasp HTR Various 878.4800 Depuy France S.A. Rasp HTR Rasp 878.4800 Diwymed Production Gmbh Rasp HTR 878.4800 DJO Inc. Rasp HTR 878.4800 Grace Manufacturing, Inc.

Source: MDRWeb.com 66 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Rasp HTR Bone rasps 878.4800 Hartmut Willutzki Rasp HTR 878.4800 Integral Design Inc. Rasp HTR Various types of instruments used for the 878.4800 J.R.I. Mfg., Ltd. fitting of hip prostheses Rasp HTR 878.4800 Kirwan Surgical Products, Inc. Rasp HTR 878.4800 Kmedic Rasp HTR Various rasps,sterile. 878.4800 Medisiss Rasp HTR Various rasps. 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Rasp HTR Various rasps. 878.4800 Medtronic Sofamor Danek Usa, Inc. Rasp HTR 878.4800 Merlyn Pharmaceuticals, Inc. Rasp HTR Various types of rasps. 878.4800 Pappas Surgical Instruments, Llc Rasp HTR 878.4800 Pompano Precision Products, Inc. Rasp HTR 878.4800 Smith & Nephew Inc.- Orthopaedics Division Rasp HTR Bone rasp. 878.4800 Spine Wave, Inc. Rasp HTR Various 878.4800 Stille Surgical Ab Rasp HTR 878.4800 Stryker Spine Rasp HTR Manual surgical instrument for general use. 878.4800 Symmetry Medical Usa, Inc. Rasp HTR 878.4800 Tuzik Boston Rasp HTR 878.4800 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Rasp HTR POWER RASP offers another option for 878.4800 Vilex, Inc. precision bone rasping and sculpturing. Rasp HTR Various rasps. 878.4800 Warsaw Orthopedic, Inc. Rasp HTR Rasp, orthopedic 878.4800 Wolfgang Atzrodt Rasp HTR 878.4800 Zimmer Holdings, Inc. Rasp HTR Rasp. 878.4800 Zimmer Spine, Inc. Rasp HTR Pf hip stem rasp assembly number 12. 878.4800 Zimmer Trabecular Metal Technology Knife, Orthopedic HTS Cartilage knife. 888.4540 Ascent Healthcare Solutions Knife, Orthopedic HTS Various types of knives. 888.4540 Biomet Microfixation Inc. Knife, Orthopedic HTS Same 888.4540 Combined Instruments (Pvt.), Ltd. Knife, Orthopedic HTS 888.4540 ConMed Linvatec Knife, Orthopedic HTS Various types of orthopedic knives. 888.4540 Depuy Mitek, A Johnson & Johnson Company Knife, Orthopedic HTS Dissector, surgical knife. 888.4540 Depuy Spine, Inc. Knife, Orthopedic HTS 888.4540 Havel’s Inc. Knife, Orthopedic HTS Electroencephalograph. 888.4540 I.T.I., Inc. Knife, Orthopedic HTS Various forms of arthroscopy knives 888.4540 Kaltec Pty. Ltd. Knife, Orthopedic HTS 888.4540 Kmedic Knife, Orthopedic HTS Various orthopedic knives,sterile. 888.4540 Medisiss Knife, Orthopedic HTS Knife, orthopedic. 888.4540 Medtronic Puerto Rico Operations Co.,Med Rel Knife, Orthopedic HTS Various types of knife orthopedic 888.4540 Rudolf Storz Gmbh Knife, Orthopedic HTS Meniscotome,various sizes 888.4540 Rz Medizintechnik Gmbh Knife, Orthopedic HTS 888.4540 Smith & Nephew Inc.- Orthopaedics Division Knife, Orthopedic HTS 888.4540 Smith & Nephew, Inc., Endoscopy Division Knife, Orthopedic HTS Scalpel. 888.4540 Spinus, Llc

Source: MDRWeb.com 67 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Knife, Orthopedic HTS Various 888.4540 Stille Surgical Ab Knife, Orthopedic HTS Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Knife, Orthopedic HTS 888.4540 Symmetry Tnco Knife, Orthopedic HTS 888.4540 Tuzik Boston Knife, Orthopedic HTS Various cartilage knives. 888.4540 Warsaw Orthopedic, Inc. Knife, Orthopedic HTS WHITNEY - Green sculps knife for removing 888.4540 Whitney Products, Inc. excess bone cement before implanting a prosthesis during hip or knee replacement surgery. Handle has thumb indentation to orient tip in hard-to-reach places. Sterile and disposable. Knife, Orthopedic HTS 888.4540 Zimmer Holdings, Inc. Knife, Orthopedic HTS Osteotome. 888.4540 Zimmer Trabecular Metal Technology Burr, Orthopedic HTT Qualtiy value in replacement cutting tools 888.4540 American Medical for powered surgical equipment of Zimmer, Specialties, Inc. Stryker, 3M and others. Burr, Orthopedic HTT Burr. 888.4540 Ascent Healthcare Solutions Burr, Orthopedic HTT Various types of burrs. 888.4540 Biomet Microfixation Inc. Burr, Orthopedic HTT Various types of burr. 888.4540 Biomet, Inc. Burr, Orthopedic HTT Full range of shapes, sizes and lengths. 888.4540 Brasseler Usa - Komet Medical Burr, Orthopedic HTT 888.4540 DJO Inc. Burr, Orthopedic HTT Surgical burr. 888.4540 Grace Engineering Corp. Burr, Orthopedic HTT Arthroscopic hydrosurgery system for bone 888.4540 Hydrocision, Inc. burring and soft-tissue management. Burr, Orthopedic HTT 888.4540 Kapp Chirurgische Instrumente Gmbh Burr, Orthopedic HTT Various orthopedic burrs,sterile. 888.4540 Medisiss Burr, Orthopedic HTT 888.4540 Micro-Aire Surgical Instruments, Inc. Burr, Orthopedic HTT 888.4540 Sim Medical Sales Burr, Orthopedic HTT Orthopedic burr. 888.4540 Small Bone Innovations, Inc. Bit, Drill HTW Drill. 888.4540 Abbott Spine, Inc. Bit, Drill HTW drills to fit synthes and other power 888.4540 American Medical equipment. Specialties, Inc. Bit, Drill HTW Drill, drill bit. 888.4540 Arthrex Manufacturing Bit, Drill HTW Drill (various size drill bits). 888.4540 Arthrex, Inc. Bit, Drill HTW Drill bit. 888.4540 Ascent Healthcare Solutions Bit, Drill HTW Various types of finger nail drills 888.4540 Baur Und Haselbarth-Chirurg Gmbh Bit, Drill HTW Unique drill bit engineered for use in 888.4540 Biomedical Enterprises, Inc. applications where removing drill cuttings from the drill hole is critical. Bit, Drill HTW Various types of drills. 888.4540 Biomet Microfixation Inc. Bit, Drill HTW Various types of drill bits. 888.4540 Biomet, Inc. Bit, Drill HTW DRILL BIT 888.4540 Blackstone Medical, Inc. Bit, Drill HTW Various. 888.4540 Bonutti Research, Inc. Bit, Drill HTW Various 888.4540 Christian Diener Gmbh. & Co. K.G. Bit, Drill HTW 888.4540 ConMed Linvatec Bit, Drill HTW Various 888.4540 Depuy Ace S.A.’R.L. Bit, Drill HTW Various 888.4540 Depuy France S.A. Bit, Drill HTW Drill. 888.4540 Depuy Mitek, A Johnson & Johnson Company Bit, Drill HTW Various sizes of surgical drill bits. 888.4540 Depuy Spine, Inc. Bit, Drill HTW Various models of bits,drill 888.4540 Dimeda Instrumente Gmbh

Source: MDRWeb.com 68 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Bit, Drill HTW Various orthopedic surgical hand drills and 888.4540 DJO Inc. bits. Bit, Drill HTW Various 888.4540 Etablissements Boutmy S.A. Bit, Drill HTW Bit, drill 888.4540 Georg Leibinger Medizintechnischer Apparatebau Bit, Drill HTW Cranial drill bit. 888.4540 Greystone Of Lincoln, Inc. Bit, Drill HTW 888.4540 Hand Biomechanics Lab, Inc. Bit, Drill HTW Various sizes and styles for drill bits. 888.4540 Integra Lifesciences Of Ohio Bit, Drill HTW 888.4540 Integral Design Inc. Bit, Drill HTW Drill bit. 888.4540 Internal Fixation Systems, Inc. Bit, Drill HTW Various types of drill bits. 888.4540 Interphase Implants, Inc. Bit, Drill HTW Various types of drill bits. 888.4540 Interventional Spine, Inc. Bit, Drill HTW Drill bit. 888.4540 K2m, Inc. Bit, Drill HTW 888.4540 Kls-Martin L.P. Bit, Drill HTW 888.4540 Kmedic Bit, Drill HTW Drill bit. 888.4540 Medcon Llc Bit, Drill HTW Various drill bits,sterile. 888.4540 Medisiss Bit, Drill HTW Various drill bits. 888.4540 Medtronic Puerto Rico Operations Co.,Med Rel Bit, Drill HTW Various twist, bit drills. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Bit, Drill HTW Various twist, bit drills. 888.4540 Medtronic Sofamor Danek Usa, Inc. Bit, Drill HTW Various. 888.4540 Medtronic Spine Llc Bit, Drill HTW Bone drill bit. 888.4540 Mekanika, Inc. Bit, Drill HTW 888.4540 Onyx Medical Corp. Bit, Drill HTW Twist drill 888.4540 Osm Gmbh Bit, Drill HTW Drill, surgical, orthopedic 888.4540 Peter Bumueller Bit, Drill HTW Pneumatic drill for ACL reconstruction. 888.4540 Richard Wolf Medical Instruments Corp. Bit, Drill HTW Drill 888.4540 S.P.O.R.T. Bit, Drill HTW Bit, drill. 888.4540 Salumedica, L.L.C. Bit, Drill HTW No common name listed 888.4540 Schad Medical Instruments Gmbh Bit, Drill HTW 888.4540 Sim Medical Sales Bit, Drill HTW 888.4540 Simpex Medical, Inc. Bit, Drill HTW Bit, drill. 888.4540 Small Bone Innovations, Inc. Bit, Drill HTW 888.4540 Smith & Nephew Inc.- Orthopaedics Division Bit, Drill HTW Twist drill 888.4540 Sphinx Tools Ltd. Bit, Drill HTW 888.4540 Spineworks Medical Inc. Bit, Drill HTW Drill bit. 888.4540 Sterilmed, Inc. Bit, Drill HTW 888.4540 Stryker Spine Bit, Drill HTW Various sizes of drill bits. 888.4540 Surgical Implant Generation Network (Sign) Bit, Drill HTW Various twist, bit drills. 888.4540 Warsaw Orthopedic, Inc. Bit, Drill HTW 888.4540 Zimmer Holdings, Inc. Bit, Drill HTW Drill bit. 888.4540 Zimmer Trabecular Metal Technology Rongeur HTX Devilbiss ronqeur 888.4540 A.T. Medical Gmbh Rongeur HTX Rongeur. 888.4540 Abbott Spine, Inc. Rongeur HTX Rong. ortho, still luer 888.4540 Accuray Surgicals, Ltd. Rongeur HTX Rongeur. 888.4540 Ascent Healthcare Solutions

Source: MDRWeb.com 69 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Rongeur HTX 888.4540 Bashir, Jamil & Bros. Pvt. Ltd. Rongeur HTX Various types of orthopedic rongeur. 888.4540 Biomet, Inc. Rongeur HTX Various types of rongeurs 888.4540 Bontempi Chirurgische Instrumente Ohg Rongeur HTX Various 888.4540 Christian Diener Gmbh. & Co. K.G. Rongeur HTX 888.4540 Codman & Shurtleff, Inc Rongeur HTX Same 888.4540 Combined Instruments (Pvt.), Ltd. Rongeur HTX Rongeur. 888.4540 Covidien Lp, Formerly Registered As United States Surgical Rongeur HTX Dental rongeur. 888.4540 Dental Usa, Inc. Rongeur HTX Various sizes and configurations of rongeurs. 888.4540 Depuy Spine, Inc. Rongeur HTX Various models of rongeurs 888.4540 Dimeda Instrumente Gmbh Rongeur HTX Various 888.4540 Diwymed Production Gmbh Rongeur HTX 888.4540 Elmed, Inc. Rongeur HTX Various 888.4540 Etablissements Boutmy S.A. Rongeur HTX Various types of rongeurs 888.4540 Gebrueder Zepf Rongeur HTX Various types of ronguers, orthopedic 888.4540 Hermann Brugger Rongeur HTX Various types and sizes of rongeurs. 888.4540 Invuity, Inc. Rongeur HTX Rongeur 888.4540 K.K. Metallic Industries Rongeur HTX Bone rongeurs. 888.4540 Kapp Chirurgische Instrumente Gmbh Rongeur HTX Various types of pliers, orthopedic 888.4540 Kashmir Surgical Co. Rongeur HTX 888.4540 Kmedic Rongeur HTX Disc ronguer. 888.4540 Koros Usa, Inc. Rongeur HTX 888.4540 Mattes & Schwarz Rongeur HTX 888.4540 Medicon Eg Rongeur HTX Various (rongeurs). 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Rongeur HTX Various (rongeurs). 888.4540 Medtronic Sofamor Danek Usa, Inc. Rongeur HTX 888.4540 Merlyn Pharmaceuticals, Inc. Rongeur HTX 888.4540 Miltex Inc. Rongeur HTX Various types of rongeur, orthopedic 888.4540 M-P Mfg., Inc. manual surgical instrument. Rongeur HTX Various 888.4540 Peter Hoehnle Rongeur HTX Various types of rongeurs 888.4540 Robert Mueller Instrumente Rongeur HTX Various 888.4540 S & A Martin Gmbh & Co. Rongeur HTX 888.4540 Scanlan International, Inc. Rongeur HTX Various laminectomy punches 888.4540 Seifring - Instrumente Gmbh. Rongeur HTX 888.4540 Smith & Nephew Inc.- Orthopaedics Division Rongeur HTX Various types of pituitary rongeurs. 888.4540 Spine Wave, Inc. Rongeur HTX Various 888.4540 Stille Surgical Ab Rongeur HTX Various 888.4540 Stoehr Medizintechnik Rongeur HTX Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Rongeur HTX 888.4540 Tecno Instruments (Pvt) Ltd. Rongeur HTX Rongeur 888.4540 Trautec-Equipamentos Cirurgicos Ltda. Rongeur HTX Various. 888.4540 Ussc Puerto Rico, Inc. Rongeur HTX 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg

Source: MDRWeb.com 70 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Rongeur HTX Various (rongeurs). 888.4540 Warsaw Orthopedic, Inc. Rongeur HTX Rongeur. 888.4540 Zimmer Spine, Inc. Rongeur HTX Ronguer. 888.4540 Zimmer Trabecular Metal Technology Instrument, Cutting, Orthopedic HTZ Percutaneous knot cutter. 878.4800 Arthrex, Inc. Instrument, Cutting, Orthopedic HTZ Acetabular grater 878.4800 Beznoska S.R.O. Instrument, Cutting, Orthopedic HTZ Various types of pin cutting instruments. 878.4800 Biomet, Inc. Instrument, Cutting, Orthopedic HTZ 878.4800 Chandjee Manufacturing Co. Instrument, Cutting, Orthopedic HTZ Various 878.4800 Chifa Instrument, Cutting, Orthopedic HTZ Various 878.4800 Christian Diener Gmbh. & Co. K.G. Instrument, Cutting, Orthopedic HTZ Same 878.4800 Combined Instruments (Pvt.), Ltd. Instrument, Cutting, Orthopedic HTZ Rod cutter. 878.4800 Depuy Spine, Inc. Instrument, Cutting, Orthopedic HTZ Various 878.4800 Diwymed Production Gmbh Instrument, Cutting, Orthopedic HTZ Instrument, cutting, orthopedic 878.4800 Friedrich Daniels Gmbh Instrument, Cutting, Orthopedic HTZ Various cutting instruments 878.4800 Gebrueder Zepf Instrument, Cutting, Orthopedic HTZ 878.4800 Gustav Weck Instrument, Cutting, Orthopedic HTZ 878.4800 Holmed Corporation Instrument, Cutting, Orthopedic HTZ 878.4800 Integral Design Inc. Instrument, Cutting, Orthopedic HTZ For arthroscopy use. 878.4800 Karl Storz Endoscopy- America Inc. Instrument, Cutting, Orthopedic HTZ 878.4800 Kmedic Instrument, Cutting, Orthopedic HTZ Various types & sizes of cutting forceps & 878.4800 M.J. Instruments Company roungers (Pvt) Ltd. Instrument, Cutting, Orthopedic HTZ 878.4800 Mahe International Inc. Instrument, Cutting, Orthopedic HTZ Various rongeurs. 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Instrument, Cutting, Orthopedic HTZ Various rongeurs. 878.4800 Medtronic Sofamor Danek Usa, Inc. Instrument, Cutting, Orthopedic HTZ 878.4800 Micrins Surgical Instruments, Inc. Instrument, Cutting, Orthopedic HTZ 878.4800 Optimal Healthcare Products Instrument, Cutting, Orthopedic HTZ Rongeurs 878.4800 Robert Mueller Instrumente Instrument, Cutting, Orthopedic HTZ 878.4800 Ruettgers Gmbh & Co. Kg, Otto Instrument, Cutting, Orthopedic HTZ Bone cutting forceps various sizes 878.4800 Rz Medizintechnik Gmbh Instrument, Cutting, Orthopedic HTZ Various 878.4800 S & A Martin Gmbh & Co. Instrument, Cutting, Orthopedic HTZ Various types of bone cutting forceps 878.4800 Seifring - Instrumente Gmbh. Instrument, Cutting, Orthopedic HTZ Disposable arthroscopic blades. 878.4800 Smith & Nephew, Inc., Endoscopy Division Instrument, Cutting, Orthopedic HTZ Cutter 878.4800 Smt Schilling Metalltechnik Gmbh Instrument, Cutting, Orthopedic HTZ Nail cutting 878.4800 Solatch Sons Instrument, Cutting, Orthopedic HTZ Various 878.4800 Stille Surgical Ab Instrument, Cutting, Orthopedic HTZ 878.4800 Storz Gmbh & Co., Karl Instrument, Cutting, Orthopedic HTZ Bone cutter 878.4800 Sufal Industries (Pvt) Ltd. Instrument, Cutting, Orthopedic HTZ 878.4800 Symmetry Tnco Instrument, Cutting, Orthopedic HTZ Various rongeurs. 878.4800 Warsaw Orthopedic, Inc. Instrument, Cutting, Orthopedic HTZ 878.4800 Zimmer Holdings, Inc. Instrument, Cutting, Orthopedic HTZ Orthopedic cutting instrument. 878.4800 Zimmer Spine, Inc. Instrument, Cutting, Orthopedic HTZ 13mn shaver. 878.4800 Zimmer Trabecular Metal Technology Impactor HWA Impactor. 888.4540 Abbott Spine, Inc.

Source: MDRWeb.com 71 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Impactor HWA Various types of orthopedic impactors. 888.4540 Biomet, Inc. Impactor HWA MULTIPLE 888.4540 Blackstone Medical, Inc. Impactor HWA STALIF C Slap Hammer 888.4540 Centinel Spine Inc. Impactor HWA Various 888.4540 Christian Diener Gmbh. & Co. K.G. Impactor HWA Mallet. 888.4540 Covidien Lp, Formerly Registered As United States Surgical Impactor HWA Various 888.4540 Diwymed Production Gmbh Impactor HWA 888.4540 George Tiemann & Co. Impactor HWA 888.4540 Holmed Corporation Impactor HWA 888.4540 Kmedic Impactor HWA Impactor. 888.4540 Lenox-Maclaren Surgical Corp. Impactor HWA Double ended impactor, impactor 888.4540 Marida, Marianne Daniels Chir. Instr. Impactor HWA Impactor. 888.4540 Medtronic Sofamor Danek Usa, Inc. Impactor HWA Surgical instrument. 888.4540 Nobel Biocare Usa, Llc Impactor HWA Impactor for placement of various sizes of 888.4540 Orthogenesis, Inc. acetabular cups. Impactor HWA Impactor 888.4540 S.P.O.R.T. Impactor HWA Impactor. 888.4540 Small Bone Innovations, Inc. Impactor HWA Mallet. 888.4540 Spine Wave, Inc. Impactor HWA 888.4540 Stryker Spine Impactor HWA Impactor. 888.4540 Warsaw Orthopedic, Inc. Impactor HWA 888.4540 Witte Gmbh Impactor HWA 888.4540 Zimmer Holdings, Inc. Impactor HWA Impactor. 888.4540 Zimmer Spine, Inc. Impactor HWA Bayonet impactor handle. 888.4540 Zimmer Trabecular Metal Technology Extractor HWB Extractor. 888.4540 Advanced Bio-Surfaces, Inc. Extractor HWB Various 888.4540 Af Instrumente Extractor HWB Extractor i. 888.4540 Anspach Effort Inc. Extractor HWB Various types of orthopedic extractor. 888.4540 Biomet, Inc. Extractor HWB Various types of removal tools. 888.4540 Depuy Mitek, A Johnson & Johnson Company Extractor HWB Surgical staple extractor, laparoscopic. 888.4540 Design Standards Corp. Extractor HWB Various types of extractors. 888.4540 Interventional Spine, Inc. Extractor HWB Extractor. 888.4540 K2m, Inc. Extractor HWB 888.4540 Kmedic Extractor HWB Multiple (driver-extractors). 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Extractor HWB Multiple (driver-extractors). 888.4540 Medtronic Sofamor Danek Usa, Inc. Extractor HWB 888.4540 Merlyn Pharmaceuticals, Inc. Extractor HWB The Woodpecker - total hip broaching 888.4540 Minnesota Bramstedt device also used for extraction of Surgical, Inc. intramedullary nails. Extractor HWB Surgical instrument. 888.4540 Nobel Biocare Usa, Llc Extractor HWB Implant remover. 888.4540 Oratronics, Inc. Extractor HWB 888.4540 Ruettgers Gmbh & Co. Kg, Otto Extractor HWB 1 model (for 2-6mm pins) - $484.00. With 3 888.4540 Rush-Berivon, Inc. interchangeable heads - additional heads available at $48.00 each.

Source: MDRWeb.com 72 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Extractor HWB Impactor/extractor-driver/extractor bone 888.4540 S.P.O.R.T. plate Extractor HWB 888.4540 Shukla Medical Extractor HWB 888.4540 Smith & Nephew Inc.- Orthopaedics Division Extractor HWB Pin puller. 888.4540 Spine Wave, Inc. Extractor HWB 888.4540 Stryker Spine Extractor HWB Extractor. 888.4540 Surgical Implant Generation Network (Sign) Extractor HWB Extractor 888.4540 Vehu Medical Instrumente Gmbh Extractor HWB Multiple (driver-extractors). 888.4540 Warsaw Orthopedic, Inc. Extractor HWB 888.4540 Witte Gmbh Extractor HWB 888.4540 Zimmer Holdings, Inc. Extractor HWB Extractor. 888.4540 Zimmer Spine, Inc. Extractor HWB Slide hammer. 888.4540 Zimmer Trabecular Metal Technology Starter, Bone Screw HWD Various models of starters, bones screws 888.4540 Dimeda Instrumente Gmbh Starter, Bone Screw HWD 888.4540 Kls-Martin L.P. Starter, Bone Screw HWD Punch. 888.4540 Surgical Implant Generation Network (Sign) Starter, Bone Screw HWD Bone screw. 888.4540 W.L. Gore & Associates,Inc Starter, Bone Screw HWD Drill bit starter tip. 888.4540 Zimmer Trabecular Metal Technology Instrument, Surgical, Orthopedic, HWE 878.4820 Accellent Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Various. 878.4820 Arthrex, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Micro power sugical system. 878.4820 Biomet Sports Medicine AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Various tyeps of electrical powered surgical 878.4820 Biomet, Inc. AC-Powered Motor and Accessory/ instruments. attachment Instrument, Surgical, Orthopedic, HWE Surgical Instrument System. 878.4820 Brasseler Usa - Medical AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE CLOWARD Posterior lumbar interbody fusion 878.4820 Cloward Instrument AC-Powered Motor and Accessory/ kit. Corporation attachment Instrument, Surgical, Orthopedic, HWE 878.4820 ConMed Linvatec AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Orthopedic instruments. 878.4820 Covidien Lp, Formerly AC-Powered Motor and Accessory/ Registered As United States attachment Surgical Instrument, Surgical, Orthopedic, HWE 878.4820 Dentsply Maillefer AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Various types of surgical instrument 878.4820 Depuy Orthopaedics, Inc. AC-Powered Motor and Accessory/ accessories/attachments, ac-powered. attachment Instrument, Surgical, Orthopedic, HWE Arthroscopic hydrosurgery system for soft- 878.4820 Hydrocision, Inc. AC-Powered Motor and Accessory/ tissue management and bone burring. attachment Instrument, Surgical, Orthopedic, HWE 878.4820 Kapp Surgical Instrument, AC-Powered Motor and Accessory/ Inc. attachment

Source: MDRWeb.com 73 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Instrument, Surgical, Orthopedic, HWE NaviPro image free hip navigation system. 878.4820 Kinamed, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE 878.4820 Kmedic AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Instruments for surgery of the hand and 878.4820 LinkBio Corp. AC-Powered Motor and Accessory/ foot. attachment Instrument, Surgical, Orthopedic, HWE Various surgical burs. 878.4820 Medtronic Sofamor Danek AC-Powered Motor and Accessory/ Instrument Manufacturing attachment Instrument, Surgical, Orthopedic, HWE Various surgical burs. 878.4820 Medtronic Sofamor Danek AC-Powered Motor and Accessory/ Usa, Inc. attachment Instrument, Surgical, Orthopedic, HWE 878.4820 Microaire Surgical AC-Powered Motor and Accessory/ Instruments, Llc attachment Instrument, Surgical, Orthopedic, HWE Hip core & bone grafting system. 878.4820 Modular Cutting Systems, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Orion-I EMF System; used in general surgical 878.4820 Ortho Development Corp. AC-Powered Motor and Accessory/ purposes in coagulation, cutting & ablation attachment of soft tissues. Instrument, Surgical, Orthopedic, HWE RX Honing Machines: Surgical #92701 or 878.4820 Rx Honing Machine AC-Powered Motor and Accessory/ hospital #92801 sharpening sets include Corporation attachment components, video and manual for orthopedic instrument sharpening. Instrument, Surgical, Orthopedic, HWE Surgical instrument and accessories/ 878.4820 Small Bone Innovations, Inc. AC-Powered Motor and Accessory/ attachments. attachment Instrument, Surgical, Orthopedic, HWE STRYKER COMMAND2 MicroElectric System. 878.4820 Stryker Australia AC-Powered Motor and Accessory/ Powered instruments for small bone surgery, attachment spinal and oral, and Maxilofacial surgery. Instrument, Surgical, Orthopedic, HWE 878.4820 Stryker Endoscopy AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Hermes tps. 878.4820 Stryker Instruments, AC-Powered Motor and Accessory/ Instruments Div. attachment Instrument, Surgical, Orthopedic, HWE Reamers. 878.4820 Symmetry Medical Usa, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Surgical Instrument System. 878.4820 Tava Surgical Instruments AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE 878.4820 Thompson Surgical AC-Powered Motor and Accessory/ Instruments, Inc. attachment Instrument, Surgical, Orthopedic, HWE 878.4820 Vilex, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Various surgical burs. 878.4820 Warsaw Orthopedic, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Various. 878.4820 Zimmer Spine, Inc. AC-Powered Motor and Accessory/ attachment Instrument, Surgical, Orthopedic, HWE Oscillating saw blade. 878.4820 Zimmer Trabecular Metal AC-Powered Motor and Accessory/ Technology attachment Corkscrew HWI Femoral head remover. 888.4540 Biomet, Inc. Corkscrew HWI 888.4540 Smith & Nephew Inc.- Orthopaedics Division Corkscrew HWI 888.4540 Zimmer Holdings, Inc.

Source: MDRWeb.com 74 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Corkscrew HWI Acetabular insert remover. 888.4540 Zimmer Trabecular Metal Technology Awl HWJ Awl. 888.4540 Abbott Spine, Inc. Awl HWJ Various types of screws. 888.4540 Biomet Microfixation Inc. Awl HWJ Various types of awl. 888.4540 Biomet, Inc. Awl HWJ BONE AWL 888.4540 Blackstone Medical, Inc. Awl HWJ STALIF C 4.5 Flexible Awl Guide 888.4540 Centinel Spine Inc. Awl HWJ Various types of awl 888.4540 Dcv Instrumente Gmbh Awl HWJ Various awls, non-sterile. 888.4540 Depuy Mitek, A Johnson & Johnson Company Awl HWJ Orthopaedic awl. 888.4540 Depuy Spine, Inc. Awl HWJ Various models of awl 888.4540 Dimeda Instrumente Gmbh Awl HWJ 888.4540 DJO Inc. Awl HWJ 888.4540 George Tiemann & Co. Awl HWJ $50.00 to $51.00 for orthognathic surgery. 888.4540 Hu-Friedy Manufacturing Co., Inc. Awl HWJ 888.4540 Integral Design Inc. Awl HWJ Awl. 888.4540 K2m, Inc. Awl HWJ Bankart shoulder repair instruments. 888.4540 Kirwan Surgical Products, Inc. Awl HWJ Mandibular awl, maxillary awl, zygomatic 888.4540 Kls-Martin L.P. arch awl. Awl HWJ 888.4540 Kmedic Awl HWJ Awl / all different. 888.4540 Lenox-Maclaren Surgical Corp. Awl HWJ Various 888.4540 Medical Implanta Medizintechnik Gmbh Awl HWJ Awl. 888.4540 Medtronic Sofamor Danek Usa, Inc. Awl HWJ Awl, orthopedic 888.4540 Schad Medical Instruments Gmbh Awl HWJ 888.4540 Smith & Nephew Inc.- Orthopaedics Division Awl HWJ Awl. 888.4540 Spine Wave, Inc. Awl HWJ Awl. 888.4540 Surgical Implant Generation Network (Sign) Awl HWJ Rc awl. 888.4540 Symmetry Medical Usa, Inc. Awl HWJ Various awls. 888.4540 Synthes San Diego Awl HWJ Awl. 888.4540 Warsaw Orthopedic, Inc. Awl HWJ 888.4540 Zimmer Holdings, Inc. Awl HWJ Awl. 888.4540 Zimmer Spine, Inc. Awl HWJ Starter awl. 888.4540 Zimmer Trabecular Metal Technology Trephine HWK Trephine. 888.4540 Ascent Healthcare Solutions Trephine HWK Blackburn trephine. 888.4540 Biomet, Inc. Trephine HWK Trephinea. 888.4540 Depuy Spine, Inc. Trephine HWK Various orthopedic trephines and 888.4540 DJO Inc. accessories. Trephine HWK 888.4540 Kmedic Trephine HWK Rochester Bone Biopsy Trephine™ and 888.4540 Medical Innovations dowel graft trephine. International Inc. Trephine HWK 888.4540 Medicon Eg Trephine HWK Holder, needle. 888.4540 Medtronic Sofamor Danek Usa, Inc. Trephine HWK Trephine. 888.4540 Orthopedic Sciences, Inc Trephine HWK Trephine 888.4540 Rudolf Storz Gmbh

Source: MDRWeb.com 75 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Trephine HWK Trephine drills. 888.4540 Salvin Dental Specialties, Inc. Trephine HWK 888.4540 Smith & Nephew Inc.- Orthopaedics Division Trephine HWK 888.4540 Stryker Corp. Trephine HWK Trephine. 888.4540 Symmetry Medical Usa, Inc. Trephine HWK Holder, needle. 888.4540 Warsaw Orthopedic, Inc. Trephine HWK 888.4540 Zimmer Holdings, Inc. Set, Hollow Mill HWL Hollow mill set. 888.4540 Biomet, Inc. Set, Hollow Mill HWL 888.4540 Smith & Nephew Inc.- Orthopaedics Division Set, Hollow Mill HWL 888.4540 Zimmer Holdings, Inc. Instrument, Compression HWN Compression instrument. 888.4540 Abbott Spine, Inc. Instrument, Compression HWN ArtAssist(R) increases arterial blood flow 888.4540 Aci Medical, Inc. by applying intermittent pneumatic compression to the foot, ankle and calf. This therapeutic device helps patients with peripheral arterial disease including non-surgical candidates, diabetic and non- diabetic ar Instrument, Compression HWN Cyro/Cuff cold and compression system. 888.4540 Aircast Llc Instrument, Compression HWN 888.4540 Alimed, Inc. Instrument, Compression HWN SEQUENTIAL CIRCULATOR lymphedema 888.4540 Bio Compression Systems, Inc. pumps, cold compression pumps for edema and gradient compression pumps. Instrument, Compression HWN EPIFOAM Post Operative Compression 888.4540 Biodermis Corp. Foam Device; post-operative compress foam device after lipectomy procedures. Instrument, Compression HWN Compression device. 888.4540 Biomet, Inc. Instrument, Compression HWN Plastic double-walled leg bags, rigid boot 888.4540 Circulator Boot Corp. (3 sizes). Canvas legging. Compression instrument. Task specific ECG monitor. All components function together as circulatory assist, limb circulatory assist and/ or as venous assist/lymph return unit. Instrument, Compression HWN 888.4540 DJO Inc. Instrument, Compression HWN machines to test lower limb and foot 888.4540 Elis - Electronic Instruments & prostheses to ISO 10328 Systems S.R.L. Instrument, Compression HWN Various types of compression instruments. 888.4540 Interventional Spine, Inc. Instrument, Compression HWN Compressor. 888.4540 K2m, Inc. Instrument, Compression HWN Instrument, compression (pliers). 888.4540 Lenox-Maclaren Surgical Corp. Instrument, Compression HWN T-BOLT III dental air compressors. 888.4540 Luckman Corporation Instrument, Compression HWN Various 888.4540 Marida, Marianne Daniels Chir. Instr. Instrument, Compression HWN Plate and screw compression devices. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Instrument, Compression HWN Plate and screw compression devices. 888.4540 Medtronic Sofamor Danek Usa, Inc. Instrument, Compression HWN 888.4540 Proconcept Instrument, Compression HWN Volumeter. 888.4540 Richardson Products, Inc. Instrument, Compression HWN 888.4540 Smith & Nephew Inc.- Orthopaedics Division Instrument, Compression HWN Plate and screw compression devices. 888.4540 Warsaw Orthopedic, Inc. Instrument, Compression HWN 888.4540 Zimmer Holdings, Inc. Instrument, Compression HWN Compression instrument. 888.4540 Zimmer Spine, Inc. Instrument, Compression HWN Patella clamp. 888.4540 Zimmer Trabecular Metal Technology Skid, Bone HWO Various types of bone skids. 888.4540 Biomet, Inc. Skid, Bone HWO Various models of skids, bones 888.4540 Dimeda Instrumente Gmbh

Source: MDRWeb.com 76 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Skid, Bone HWO Skid, bone 888.4540 Friedrich Daniels Gmbh Skid, Bone HWO 888.4540 George Tiemann & Co. Skid, Bone HWO 888.4540 Integral Design Inc. Skid, Bone HWO 888.4540 Kirwan Surgical Products, Inc. Skid, Bone HWO Various types of skid, bone 888.4540 Rudolf Storz Gmbh Skid, Bone HWO No common name listed 888.4540 Schad Medical Instruments Gmbh Skid, Bone HWO 888.4540 Smith & Nephew Inc.- Orthopaedics Division Skid, Bone HWO 888.4540 Tuzik Boston Skid, Bone HWO Bone skid. 888.4540 Warsaw Orthopedic, Inc. Skid, Bone HWO 888.4540 Zimmer Holdings, Inc. Punch, Femoral Neck HWP Moore hollow chisel. 888.4540 Biomet, Inc. Punch, Femoral Neck HWP Bone screw extractor. 888.4540 Depuy Spine, Inc. Punch, Femoral Neck HWP 888.4540 Fehling Surgical Instruments Punch, Femoral Neck HWP 888.4540 Stryker Spine Punch, Femoral Neck HWP 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Punch, Femoral Neck HWP Femoral neck punch. 888.4540 Warsaw Orthopedic, Inc. Punch, Femoral Neck HWP 888.4540 Zimmer Holdings, Inc. Punch, Femoral Neck HWP Box osteotome. 888.4540 Zimmer Trabecular Metal Technology Passer HWQ Suture retriver/passer. 888.4540 Arthrex California, Inc. Passer HWQ Suture passer. 888.4540 Depuy Mitek, A Johnson & Johnson Company Passer HWQ Tendon passer. 888.4540 Mizuho Osi Passer HWQ 888.4540 Smith & Nephew Inc.- Orthopaedics Division Passer HWQ 888.4540 Zimmer Holdings, Inc. Driver, Prosthesis HWR Various types of prosthesis driver. 888.4540 Biomet, Inc. Driver, Prosthesis HWR Knee driver. 888.4540 Bioquest Driver, Prosthesis HWR ROD PUSHER 888.4540 Blackstone Medical, Inc. Driver, Prosthesis HWR 888.4540 Boston Scientific Corporation Driver, Prosthesis HWR STALIF C Inserter 888.4540 Centinel Spine Inc. Driver, Prosthesis HWR 888.4540 DJO Inc. Driver, Prosthesis HWR Utah ServoPro System. 888.4540 Motion Control, Inc. Driver, Prosthesis HWR New version control Hip Stem Inserter and 888.4540 Nemcomed Universal Hip Stem Extractor. Driver, Prosthesis HWR 888.4540 Smith & Nephew Inc.- Orthopaedics Division Driver, Prosthesis HWR 888.4540 Stryker Spine Driver, Prosthesis HWR Various types of prosthesis drivers. 888.4540 Warsaw Orthopedic, Inc. Driver, Prosthesis HWR 888.4540 Zimmer Holdings, Inc. Driver, Prosthesis HWR Hip stem bullet nose impactor. 888.4540 Zimmer Trabecular Metal Technology Template HWT Template. 888.4800 Abbott Spine, Inc. Template HWT Applicator; Syed-Neblett GYN I, II & III, 888.4800 Best Medical International, Templates & Kits, Prostate, Urethral, Rectal Inc. Template & Kits; Disposable Prostate, Rectal & GYN Templates. Template HWT Deyerle femoral template. 888.4800 Biomet, Inc. Template HWT Fmoral neck cut guide. 888.4800 Bioquest Template HWT TEMPLATE 888.4800 Blackstone Medical, Inc. Template HWT STALIF C Sizing Trial, var. sizes 888.4800 Centinel Spine Inc.

Source: MDRWeb.com 77 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Template HWT Anatomical models. 888.4800 Demetech Corp. Template HWT Template. 888.4800 Depuy Spine, Inc. Template HWT Template/sizer 888.4800 Diwymed Production Gmbh Template HWT Template. 888.4800 K2m, Inc. Template HWT 888.4800 Kls-Martin L.P. Template HWT Anatomical models. 888.4800 Medical Modeling Inc Template HWT Template. 888.4800 Medtronic Sofamor Danek Instrument Manufacturing Template HWT Template. 888.4800 Medtronic Sofamor Danek Usa, Inc. Template HWT Template for clinical use 888.4800 Orthofix Srl Template HWT Multiple types of templates.; MULTIPLE; 888.4800 Otismed Corporation OSTEONICS AWL; TEMPLATE; VARIOUS Template HWT Anatomical models. 888.4800 Protomed Template HWT Trial femoral template 888.4800 S.P.O.R.T. Template HWT Template. 888.4800 Small Bone Innovations, Inc. Template HWT Template. 888.4800 Spine Wave, Inc. Template HWT 888.4800 Stryker Spine Template HWT 888.4800 Summit Business Products, Inc. Template HWT Jig.; DISTAL TARGETING TOOL (ASSY.); 888.4800 Surgical Implant Generation PROXIMAL Network (Sign) Template HWT Template. 888.4800 Warsaw Orthopedic, Inc. Template HWT 888.4800 Zimmer Holdings, Inc. Template HWT Various types of templates and gauge sets. 888.4800 Zimmer Manufacturing B.V. Template HWT Template. 888.4800 Zimmer Spine, Inc. Template HWT Drill template. 888.4800 Zimmer Trabecular Metal Technology Countersink HWW Countersink. 888.4540 Ascent Healthcare Solutions Countersink HWW Bone screw countersink. 888.4540 Biomet, Inc. Countersink HWW Various types of countersinks. 888.4540 Interventional Spine, Inc. Countersink HWW 888.4540 Kmedic Countersink HWW Countersink. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Countersink HWW Countersink. 888.4540 Medtronic Sofamor Danek Usa, Inc. Countersink HWW Countersink. 888.4540 Small Bone Innovations, Inc. Countersink HWW 888.4540 Smith & Nephew Inc.- Orthopaedics Division Countersink HWW Countersink. 888.4540 Warsaw Orthopedic, Inc. Countersink HWW 888.4540 Zimmer Holdings, Inc. Countersink HWW Countersink tamp. 888.4540 Zimmer Trabecular Metal Technology Tap, Bone HWX Tap. 888.4540 Abbott Spine, Inc. Tap, Bone HWX Tap. 888.4540 Ascent Healthcare Solutions Tap, Bone HWX Tap, bone. 888.4540 Biomet Microfixation Inc. Tap, Bone HWX Various types of bone screw taps. 888.4540 Biomet, Inc. Tap, Bone HWX Tap, bone. 888.4540 Bioplate, Inc. Tap, Bone HWX CANNULATED TAP; CANUULATED TAP 888.4540 Blackstone Medical, Inc. Tap, Bone HWX Various bone taps. 888.4540 Depuy Mitek, A Johnson & Johnson Company Tap, Bone HWX Bone tap. 888.4540 Depuy Spine, Inc. Tap, Bone HWX Various models of taps,bone 888.4540 Dimeda Instrumente Gmbh Tap, Bone HWX 888.4540 DJO Inc.

Source: MDRWeb.com 78 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Tap, Bone HWX Bone tap. 888.4540 Grace Engineering Corp. Tap, Bone HWX 888.4540 Holmed Corporation Tap, Bone HWX Tap. 888.4540 Interventional Spine, Inc. Tap, Bone HWX Tap. 888.4540 K2m, Inc. Tap, Bone HWX 888.4540 Kmedic Tap, Bone HWX Tap, bone. 888.4540 Lenox-Maclaren Surgical Corp. Tap, Bone HWX Various bone taps,sterile. 888.4540 Medisiss Tap, Bone HWX 888.4540 Onyx Medical Corp. Tap, Bone HWX Ht tap, st tap. 888.4540 RTI Biologics Inc. Tap, Bone HWX 888.4540 Smith & Nephew Inc.- Orthopaedics Division Tap, Bone HWX Tap. 888.4540 Spine Wave, Inc. Tap, Bone HWX Bone tap. 888.4540 Sterilmed, Inc. Tap, Bone HWX 888.4540 Stryker Spine Tap, Bone HWX Various types and sizes of bone taps. 888.4540 Synthes (Usa) Tap, Bone HWX Specialized machinery for the production 888.4540 Tsugami / Rem Sales Inc. of taps, bone screws, fixation devices, and inplants. Tap, Bone HWX Tap, bone 888.4540 Udo Schilling Cnc-Drehteile Tap, Bone HWX Bone tap. 888.4540 Warsaw Orthopedic, Inc. Tap, Bone HWX 888.4540 Zimmer Holdings, Inc. Tap, Bone HWX Bone tap. 888.4540 Zimmer Spine, Inc. Probe HXB Various opthalmic probes. 888.4540 Accutome, Inc. Probe HXB Various types of probes. 888.4540 Allez Medical Applications, Inc. Probe HXB 888.4540 Allgaier Instrumente Gmbh Probe HXB Probe. 888.4540 Arthrex California, Inc. Probe HXB Various. 888.4540 Biomet, Inc. Probe HXB MULTIPLE 888.4540 Blackstone Medical, Inc. Probe HXB Transesophageal probe sheath cover. 888.4540 Civco Medical Instruments Co., Inc. Probe HXB 888.4540 Cml Consortium De Materiel Pour Lab. Probe HXB Same 888.4540 Combined Instruments (Pvt.), Ltd. Probe HXB Various types of probes 888.4540 Dcv Instrumente Gmbh Probe HXB Dental probe. 888.4540 Dental Usa, Inc. Probe HXB Various types of orthopedic probes. 888.4540 Depuy Mitek, A Johnson & Johnson Company Probe HXB Orthopaedic probe. 888.4540 Depuy Spine, Inc. Probe HXB Various models of probes 888.4540 Dimeda Instrumente Gmbh Probe HXB Various 888.4540 Gebrueder Zepf Probe HXB 888.4540 Gribi Ag Belp Probe HXB Laparoscope. 888.4540 Gyrus Medical, Inc. Probe HXB Probe 888.4540 Hermann Mueller Probe HXB Bipolar coag probe. 888.4540 Hydromer, Inc. Probe HXB Laparoscope. 888.4540 Innervision Inc. Probe HXB Opthalmic light pipes (probes). 888.4540 Insight Instruments, Inc. Probe HXB Various types and sizes of probes. 888.4540 Invuity, Inc. Probe HXB Probe 888.4540 K.T. Surgico (Pvt), Ltd. Probe HXB Feeler,probe. 888.4540 K2m, Inc. Probe HXB 888.4540 Karl Storz Endoscopy- America Inc.

Source: MDRWeb.com 79 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Probe HXB Various probes dental disposable 888.4540 Kencap Ltd. Probe HXB 888.4540 Martin Gmbh & Co. Kg, Gebr. Probe HXB Laparoscope. 888.4540 Mectra Labs, Inc. Probe HXB Various probes. 888.4540 Medtronic Puerto Rico Operations Co.,Med Rel Probe HXB Products and accessories to aid in embryo 888.4540 Micromanipulator Co., Inc., recovery, grading, splitting, injection, The micromanipulation and photomicrography. Probe HXB Probe 888.4540 Panorama Intl. Probe HXB 888.4540 Pru-Dent Manufacturing Co. Probe HXB Various 888.4540 S.O.R. Internacional, S.A. Probe HXB 888.4540 Smith & Nephew Inc.- Orthopaedics Division Probe HXB Probes/excavators 888.4540 Solatch Sons Probe HXB Various types of probes. 888.4540 Spine Wave, Inc. Probe HXB Various 888.4540 Stille Surgical Ab Probe HXB Various. 888.4540 Stryker Instruments, Instruments Div. Probe HXB Probe.; SLOT FINDER TOOL 888.4540 Surgical Implant Generation Network (Sign) Probe HXB Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Probe HXB 888.4540 Symmetry Tnco Probe HXB Probe 888.4540 Vehu Medical Instrumente Gmbh Probe HXB 888.4540 Wisap America Probe HXB 888.4540 Wisap Gesellschaft Fur Wisseusch Apparatebau M.B.H. Probe HXB 888.4540 Witte Gmbh Probe HXB Probe. 888.4540 Zimmer Spine, Inc. Probe HXB Distal spacer sound. 888.4540 Zimmer Trabecular Metal Technology Probe HXB PH probe. 888.4540 Zinetics Medical, Inc. Wrench HXC Wrench. 888.4540 Abbott Spine, Inc. Wrench HXC Wrench. 888.4540 Biomet Microfixation Inc. Wrench HXC Various types of orthopedic wrenches. 888.4540 Biomet, Inc. Wrench HXC COUNTER TORQUE; COUNTER TORQUE 888.4540 Blackstone Medical, Inc. WRENCH Wrench HXC Orthopaedic wrench. 888.4540 Depuy Spine, Inc. Wrench HXC Various models of wrenches 888.4540 Dimeda Instrumente Gmbh Wrench HXC Various 888.4540 Diwymed Production Gmbh Wrench HXC 888.4540 DJO Inc. Wrench HXC ES Tools stainless steel wrenches. 888.4540 Emporium Specialties Co., Inc. Wrench HXC Wrench. 888.4540 Feiter’s Inc Wrench HXC Wrench 888.4540 Georg Leibinger Medizintechnischer Apparatebau Wrench HXC 888.4540 Holmed Corporation Wrench HXC Wrench. 888.4540 K2m, Inc. Wrench HXC Various types of orthopedic wrenches. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Wrench HXC Various types of orthopedic wrenches. 888.4540 Medtronic Sofamor Danek Usa, Inc. Wrench HXC Surgical or prosthetic instrument. 888.4540 Nobel Biocare Usa, Llc

Source: MDRWeb.com 80 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Wrench HXC Cylinder wrench. 888.4540 Seven Harvest Intl. Import & Export Wrench HXC Wrench. 888.4540 Spine Wave, Inc. Wrench HXC 888.4540 Stryker Spine Wrench HXC Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Wrench HXC Various types of orthopedic wrenches. 888.4540 Warsaw Orthopedic, Inc. Wrench HXC 888.4540 Zimmer Holdings, Inc. Wrench HXC Wrench. 888.4540 Zimmer Spine, Inc. Wrench HXC Cross bar handle. 888.4540 Zimmer Trabecular Metal Technology Clamp HXD Bone instruments 878.4800 Baur Und Haselbarth-Chirurg Gmbh Clamp HXD Various types of clamps. 878.4800 Biomet Microfixation Inc. Clamp HXD Various types of clamp. 878.4800 Biomet, Inc. Clamp HXD Various styles of clamps. 878.4800 Cardinal Health, Snowden Pencer Products Clamp HXD Orthopedic clamp 878.4800 Combined Instruments (Pvt.), Ltd. Clamp HXD Clamps 878.4800 Dar Expo Clamp HXD Various types of clamps. 878.4800 Deroyal Surgical - Rose Hill Clamp HXD Various models of clamps 878.4800 Dimeda Instrumente Gmbh Clamp HXD Various types of clamps 878.4800 Frimed Medizintechnik Gmbh Clamp HXD Varians types 878.4800 Hall & Scheier Clamp HXD Various 878.4800 K.K. Metallic Industries Clamp HXD Various 878.4800 Kashmir Surgical Co. Clamp HXD Various 878.4800 Kencap Ltd. Clamp HXD 878.4800 Kmedic Clamp HXD 878.4800 Medicon Eg Clamp HXD Multiple (orthopedic clamps). 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Clamp HXD Multiple (orthopedic clamps). 878.4800 Medtronic Sofamor Danek Usa, Inc. Clamp HXD 878.4800 Merlyn Pharmaceuticals, Inc. Clamp HXD Surgical instrument. 878.4800 Nobel Biocare Usa, Llc Clamp HXD The clamp. 878.4800 Pos-T-Vac, Inc. Clamp HXD Clamp. 878.4800 Qfc Plastics, Inc. Clamp HXD Clamp 878.4800 Rz Medizintechnik Gmbh Clamp HXD Edna towel clamp 878.4800 Sh Medizintechnik Gmbh Clamp HXD Breast compressor clamp. 878.4800 Sta-Sof Breast Compressor- Clamp Clamp HXD Manual surgical instrument for general use. 878.4800 Symmetry Medical Usa, Inc. Clamp HXD Clamp. 878.4800 Terumo Cardiovascular Systems (Tcvs) Clamp HXD 878.4800 Tuzik Boston Clamp HXD 878.4800 Ulrich Ag Clamp HXD 878.4800 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Clamp HXD Various 878.4800 Waldemar Krotz Clamp HXD Multiple (orthopedic clamps). 878.4800 Warsaw Orthopedic, Inc. Clamp HXD 878.4800 Witte Gmbh Clamp HXD 878.4800 Zimmer Holdings, Inc. Fork HXE 888.4540 Cml Consortium De Materiel Pour Lab. Fork HXE Fork. 888.4540 K2m, Inc.

Source: MDRWeb.com 81 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Fork HXE Fork, fork hammer. 888.4540 Medtronic Sofamor Danek Usa, Inc. Fork HXE Right angle folding fork. 888.4540 R. D. Equipment, Inc. Fork HXE Fork, fork hammer. 888.4540 Warsaw Orthopedic, Inc. Fork HXE Hip retractor. 888.4540 Zimmer Trabecular Metal Technology Tamp HXG Tamp. 888.4540 Abbott Spine, Inc. Tamp HXG Various types of orthopedic wire tamps. 888.4540 Biomet, Inc. Tamp HXG Impactor. 888.4540 Depuy Spine, Inc. Tamp HXG Tamp 888.4540 Hermann Mueller Tamp HXG Tamp. 888.4540 K2m, Inc. Tamp HXG Multple tamps. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Tamp HXG Multple tamps. 888.4540 Medtronic Sofamor Danek Usa, Inc. Tamp HXG Various types of sterile, inflatable bone 888.4540 Medtronic Spine Llc tamps. Tamp HXG 888.4540 Osseon Therapeutics, Inc. Tamp HXG Tamp 888.4540 Pfau Medizinische Instrumente Gmbh Tamp HXG Various types of tamps. 888.4540 Spine Wave, Inc. Tamp HXG Bone tamp. 888.4540 Symmetry Medical Usa, Inc. Tamp HXG Multple tamps. 888.4540 Warsaw Orthopedic, Inc. Tamp HXG 888.4540 Zimmer Holdings, Inc. Tamp HXG Tamp. 888.4540 Zimmer Spine, Inc. Tamp HXG Acetabular, restrictor trial-tamp. 888.4540 Zimmer Trabecular Metal Technology Passer, Wire, Orthopedic HXI Various types of wire. 888.4540 Biomet Microfixation Inc. Passer, Wire, Orthopedic HXI Various orthopedic wire passers. 888.4540 Biomet, Inc. Passer, Wire, Orthopedic HXI Various models of passers, wire, orthopedic 888.4540 Dimeda Instrumente Gmbh Passer, Wire, Orthopedic HXI Various types of passer wires. 888.4540 Interventional Spine, Inc. Passer, Wire, Orthopedic HXI 888.4540 Kmedic Passer, Wire, Orthopedic HXI Interference screw guidewire. 888.4540 RTI Biologics Inc. Passer, Wire, Orthopedic HXI $165.00ea - with 2, 3, or 5cm loops. $165.00 888.4540 Rush-Berivon, Inc. for slotted, orthopedic wire passer. Passer, Wire, Orthopedic HXI Various types of guide wires. 888.4540 Spine Wave, Inc. Passer, Wire, Orthopedic HXI 888.4540 Stryker Spine Passer, Wire, Orthopedic HXI 888.4540 Zimmer Holdings, Inc. Staple Driver HXJ Various models of staple drivers 888.4540 Dimeda Instrumente Gmbh Staple Driver HXJ Various staple drivers,sterile. 888.4540 Medisiss Holder, Needle, Orthopedic HXK Holder 888.4540 Banzai Corp. Holder, Needle, Orthopedic HXK Various types of needles. 888.4540 Biomet Microfixation Inc. Holder, Needle, Orthopedic HXK Various types of needle holders. 888.4540 Biomet, Inc. Holder, Needle, Orthopedic HXK Same 888.4540 Combined Instruments (Pvt.), Ltd. Holder, Needle, Orthopedic HXK Holder, needle; orthopedic 888.4540 Everlast Surgical Co. Holder, Needle, Orthopedic HXK No common name listed 888.4540 Faustino Rincon Holder, Needle, Orthopedic HXK 888.4540 Fehling Surgical Instruments Holder, Needle, Orthopedic HXK Various types of needle holders for 888.4540 Friedrich Daniels Gmbh orthopedical use Holder, Needle, Orthopedic HXK Holder, Needle, Orthopedic. 888.4540 Gustav Weck Holder, Needle, Orthopedic HXK 888.4540 Kmedic Holder, Needle, Orthopedic HXK 888.4540 Mattes & Schwarz

Source: MDRWeb.com 82 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Holder, Needle, Orthopedic HXK Holder, needle. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Holder, Needle, Orthopedic HXK Needle holders, orthopedics 888.4540 Mount Blonck Trading Holder, Needle, Orthopedic HXK $110.00 for unit with carbide inserts; $84.50 888.4540 Nordent Manufacturing, Inc. for s.s. Holder, Needle, Orthopedic HXK Needle holder 888.4540 Rainer Rosenkranz Chirurgische Instrumente Manufac Holder, Needle, Orthopedic HXK Various types of needle holders. 888.4540 Salvin Dental Specialties, Inc. Holder, Needle, Orthopedic HXK Various 888.4540 Stille Surgical Ab Holder, Needle, Orthopedic HXK Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Holder, Needle, Orthopedic HXK Needle holder, orthopedic 888.4540 The Strong Hand Holder, Needle, Orthopedic HXK 888.4540 Tuzik Boston Holder, Needle, Orthopedic HXK 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Holder, Needle, Orthopedic HXK 888.4540 Zimmer Holdings, Inc. Holder, Needle, Orthopedic HXK Stem holder. 888.4540 Zimmer Trabecular Metal Technology Mallet HXL Mallet. 878.4800 Abbott Spine, Inc. Mallet HXL 878.4800 Bashir, Jamil & Bros. Pvt. Ltd. Mallet HXL Various types of orthopedic mallets. 878.4800 Biomet, Inc. Mallet HXL 878.4800 Codman & Shurtleff, Inc Mallet HXL 878.4800 DJO Inc. Mallet HXL 878.4800 Dynamic Surgical (Pvt.) Ltd. Mallet HXL 878.4800 Elmed, Inc. Mallet HXL 878.4800 George Tiemann & Co. Mallet HXL Mallet, all types. 878.4800 H & H Co. Mallet HXL 878.4800 Holmed Corporation Mallet HXL 878.4800 Integral Design Inc. Mallet HXL 878.4800 Kirwan Surgical Products, Inc. Mallet HXL 878.4800 Kmedic Mallet HXL 878.4800 Medicon Eg Mallet HXL Multiple (surgical mallets). 878.4800 Medtronic Sofamor Danek Instrument Manufacturing Mallet HXL Multiple (surgical mallets). 878.4800 Medtronic Sofamor Danek Usa, Inc. Mallet HXL 878.4800 Merlyn Pharmaceuticals, Inc. Mallet HXL 878.4800 Miltex Inc. Mallet HXL Various types of orthopedic mallets 878.4800 Nagashima Medical Instruments Co., Ltd. Mallet HXL Bone Mallets are designed to incorporate 878.4800 Precision Medical a proper balance and weight with stainless Manufacturing Corporation steel construction. All handles are stainless steel and hollow. Some models come with replaceable nylon head prevents from transmitting the shock to patient. Mallet HXL $158.00 for 16 oz units. 878.4800 Rush-Berivon, Inc. Mallet HXL Mallet. 878.4800 Salvin Dental Specialties, Inc. Mallet HXL Various 878.4800 Stille Surgical Ab Mallet HXL 878.4800 Stryker Spine Mallet HXL 878.4800 Tuzik Boston Mallet HXL 878.4800 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Mallet HXL Multiple (surgical mallets). 878.4800 Warsaw Orthopedic, Inc. Mallet HXL 878.4800 Zimmer Holdings, Inc. Applier, Cerclage HXN Applier, cerclage. 888.4540 Arthrex, Inc.

Source: MDRWeb.com 83 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Applier, Cerclage HXN Parham band clamp. 888.4540 Biomet, Inc. Applier, Cerclage HXN Various models of appliers,cerclage 888.4540 Dimeda Instrumente Gmbh Applier, Cerclage HXN 888.4540 Witte Gmbh Applier, Cerclage HXN 888.4540 Zimmer Holdings, Inc. Pusher, Socket HXO Cup positioning and aiming device. 888.4540 Biomet, Inc. Pusher, Socket HXO REDUCTION INSTRUMENT 888.4540 Blackstone Medical, Inc. Pusher, Socket HXO Various types of orthopedic socket pushers. 888.4540 Depuy-Raynham, A Div. Of Depuy Orthopaedics Pusher, Socket HXO Various 888.4540 Marida, Marianne Daniels Chir. Instr. Pusher, Socket HXO Socket. 888.4540 Medtronic Sofamor Danek Usa, Inc. Pusher, Socket HXO 888.4540 Stryker Spine Pusher, Socket HXO Socket. 888.4540 Warsaw Orthopedic, Inc. Pusher, Socket HXO 888.4540 Zimmer Holdings, Inc. Pusher, Socket HXO Retractor. 888.4540 Zimmer Trabecular Metal Technology Instrument, Bending or Contouring HXP Bender. 888.4540 Abbott Spine, Inc. Instrument, Bending or Contouring HXP Orthopedic manual instruments, various. 888.4540 Arthronet Medical, Inc. Instrument, Bending or Contouring HXP Various types of benoing instruments. 888.4540 Biomet, Inc. Instrument, Bending or Contouring HXP Various 888.4540 Christian Diener Gmbh. & Co. K.G. Instrument, Bending or Contouring HXP Contouring instrument. 888.4540 Depuy Spine, Inc. Instrument, Bending or Contouring HXP Various 888.4540 Diwymed Production Gmbh Instrument, Bending or Contouring HXP Bending iron, comp tech 888.4540 Friedrich Daniels Gmbh Instrument, Bending or Contouring HXP Orthopedic manual instrumensts, various 888.4540 Imtec Medizintechnik, Gmbh Instrument, Bending or Contouring HXP Bender. 888.4540 K2m, Inc. Instrument, Bending or Contouring HXP Plate bending tool, bending pliers. 888.4540 Kls-Martin L.P. Instrument, Bending or Contouring HXP Various rod benders. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Instrument, Bending or Contouring HXP Various rod benders. 888.4540 Medtronic Sofamor Danek Usa, Inc. Instrument, Bending or Contouring HXP 888.4540 Musculoskeletal Transplant Foundation Instrument, Bending or Contouring HXP Various types of bending instruments 888.4540 Ortho Medical Gmbh Implants Instrument, Bending or Contouring HXP 888.4540 Smith & Nephew Inc.- Orthopaedics Division Instrument, Bending or Contouring HXP Various 888.4540 Smt Schilling Metalltechnik Gmbh Instrument, Bending or Contouring HXP Various 888.4540 Stille Surgical Ab Instrument, Bending or Contouring HXP Tessier instruments. 888.4540 Striker Corp. Instrument, Bending or Contouring HXP Various rod benders. 888.4540 Warsaw Orthopedic, Inc. Instrument, Bending or Contouring HXP 888.4540 Zimmer Holdings, Inc. Instrument, Bending or Contouring HXP Bending or conforming instrument. 888.4540 Zimmer Spine, Inc. Instrument, Bending or Contouring HXP Starter femoral shaver, mini plus number 9. 888.4540 Zimmer Trabecular Metal Technology Crimper, Pin HXQ Dee fixation clamp. 888.4540 Biomet, Inc. Crimper, Pin HXQ Various tension crimper. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Crimper, Pin HXQ Various tension crimper. 888.4540 Medtronic Sofamor Danek Usa, Inc. Crimper, Pin HXQ Various tension crimper. 888.4540 Warsaw Orthopedic, Inc. Crimper, Pin HXQ 888.4540 Zimmer Holdings, Inc. Spatula, Orthopedic HXR MULTIPLE 878.4800 Blackstone Medical, Inc.

Source: MDRWeb.com 84 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Spatula, Orthopedic HXR Same 878.4800 Combined Instruments (Pvt.), Ltd. Spatula, Orthopedic HXR 878.4800 Smith & Nephew Inc.- Orthopaedics Division Twister, Wire HXS Wire twister. 888.4540 Abbott Spine, Inc. Twister, Wire HXS Various types of wire. 888.4540 Biomet Microfixation Inc. Twister, Wire HXS Various types of wire twisters. 888.4540 Biomet, Inc. Twister, Wire HXS Various twister, wire, orthopedic 888.4540 Christian Diener Gmbh. & Co. K.G. Twister, Wire HXS 888.4540 Deknatel Snowden-Pencer Twister, Wire HXS Various models of twisters, wire 888.4540 Dimeda Instrumente Gmbh Twister, Wire HXS Various types of twister, wire, orthopedic 888.4540 Hall & Scheier Twister, Wire HXS 888.4540 Hipp Gmbh, Anton Twister, Wire HXS 888.4540 Kapp Chirurgische Instrumente Gmbh Twister, Wire HXS Wire twisting forceps. 888.4540 Kls-Martin L.P. Twister, Wire HXS 888.4540 Kmedic Twister, Wire HXS Probe. 888.4540 Lenox-Maclaren Surgical Corp. Twister, Wire HXS Guidewire, stylet, braided stylet. 888.4540 Rgi Medical Manufacturing Inc. Twister, Wire HXS Various 888.4540 Rudolf Storz Gmbh Twister, Wire HXS Wire holding clamp,various sizes 888.4540 Rz Medizintechnik Gmbh Twister, Wire HXS 888.4540 Smith & Nephew Inc.- Orthopaedics Division Twister, Wire HXS Fine wire braiders with 3-144 carriers with 888.4540 Steeger Usa, Llc intelligent control. Suitable for catheters and medical devices. Also, make braiding equipment. Twister, Wire HXS 888.4540 Tuzik Boston Twister, Wire HXS 888.4540 Zimmer Holdings, Inc. Tape, Orthopedic HXT Athletic and therapeutic tapes. 878.4800 Arrowhead Athletics Tape, Orthopedic HXT Fiberglass casting tape. 878.4800 Debusk Orthopedic Casting (Doc) Tape, Orthopedic HXT 878.4800 Dumex Medical Surgical Products Ltd. Tape, Orthopedic HXT Tendon spacer. 878.4800 Medist International Tape, Orthopedic HXT GAUZTAPE 878.4800 Modern Aids, Inc. Tape, Orthopedic HXT Gauztape. 878.4800 Modern Aids, Inc. Tape, Orthopedic HXT 878.4800 Ossur Americas Tape, Orthopedic HXT Various sizes of orthopedic tape. 878.4800 Patterson Medical Supply, Inc. Tape, Orthopedic HXT Orthopedic elastic tapes and webbings. 878.4800 Valley Products Co. Bender HXW Brace bending iron. 888.4540 Biomet, Inc. Bender HXW Rod bender. 888.4540 Bioquest Bender HXW MULTIPLE 888.4540 Blackstone Medical, Inc. Bender HXW Various 888.4540 Christian Diener Gmbh. & Co. K.G. Bender HXW 888.4540 Holmed Corporation Bender HXW Bender. 888.4540 K2m, Inc. Bender HXW GRATLOCH wire bender for stabilizing and 888.4540 Kmedic bending a Kirschner wire simultaneously. Bender HXW Various benders. 888.4540 Medtronic Sofamor Danek Usa, Inc. Bender HXW $127.00 for 2mm thru 6mm pin usage. 888.4540 Rush-Berivon, Inc.

Source: MDRWeb.com 85 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Bender HXW 888.4540 Smith & Nephew Inc.- Orthopaedics Division Bender HXW Various types of rod benders. 888.4540 Spine Wave, Inc. Bender HXW Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Bender HXW Various benders. 888.4540 Warsaw Orthopedic, Inc. Bender HXW 888.4540 Zimmer Holdings, Inc. Screwdriver HXX Screwdriver. 888.4540 Abbott Spine, Inc. Screwdriver HXX Orthopedic screwdriver. 888.4540 Biomet Microfixation Inc. Screwdriver HXX Various types of orthopedic screwdrivers. 888.4540 Biomet, Inc. Screwdriver HXX SCREW DRIVER 888.4540 Blackstone Medical, Inc. Screwdriver HXX Stalif C 2.5 Universal Screwdriver 888.4540 Centinel Spine Inc. Screwdriver HXX Various 888.4540 Christian Diener Gmbh. & Co. K.G. Screwdriver HXX Orthopedic screw driver 888.4540 Combined Instruments (Pvt.), Ltd. Screwdriver HXX Various 888.4540 Depuy Ace S.A.’R.L. Screwdriver HXX Various orthopedic screwdrivers. 888.4540 Depuy Mitek, A Johnson & Johnson Company Screwdriver HXX Screwdriver, hexhead. 888.4540 Depuy Spine, Inc. Screwdriver HXX Various models of screwdrivers 888.4540 Dimeda Instrumente Gmbh Screwdriver HXX 888.4540 DJO Inc. Screwdriver HXX Screwdriver. 888.4540 Gauthier Biomedical, Inc. Screwdriver HXX Screwdriver 888.4540 Georg Leibinger Medizintechnischer Apparatebau Screwdriver HXX Pocket screwdrivers. 888.4540 Hilco Screwdriver HXX 888.4540 Holmed Corporation Screwdriver HXX Various types of drivers. 888.4540 Interventional Spine, Inc. Screwdriver HXX Screw inserter, driver. 888.4540 K2m, Inc. Screwdriver HXX 888.4540 Kls-Martin L.P. Screwdriver HXX 888.4540 Kmedic Screwdriver HXX Various 888.4540 Medical Implanta Medizintechnik Gmbh Screwdriver HXX Screwdriver, orthopedic. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Screwdriver HXX Screwdriver, orthopedic. 888.4540 Medtronic Sofamor Danek Usa, Inc. Screwdriver HXX 888.4540 Microcision Llc Screwdriver HXX Prosthetic instrument. 888.4540 Nobel Biocare Usa, Llc Screwdriver HXX Modular handle, screwdriver. 888.4540 RTI Biologics Inc. Screwdriver HXX Screwdriver 888.4540 Rz Medizintechnik Gmbh Screwdriver HXX Various types of dental screwdrivers and 888.4540 Salvin Dental Specialties, Inc. accessories. Screwdriver HXX Various types of screwdrivers, screwdriver 888.4540 Schad Medical Instruments orthopedic Gmbh Screwdriver HXX HANDLE ONLY; SCREWDRIVER 888.4540 Small Bone Innovations, Inc. Screwdriver HXX Orthopedic manual surgical instrument. 888.4540 Small Bone Innovations, Inc. Screwdriver HXX 888.4540 Smith & Nephew Inc.- Orthopaedics Division Screwdriver HXX Screwdriver 888.4540 Smt Schilling Metalltechnik Gmbh Screwdriver HXX Various types of screwdrivers. 888.4540 Spine Wave, Inc. Screwdriver HXX 888.4540 Stryker Corp. Screwdriver HXX 888.4540 Stryker Spine

Source: MDRWeb.com 86 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Screwdriver HXX Screw driver.; HEX DRIVER 888.4540 Surgical Implant Generation Network (Sign) Screwdriver HXX Various types of screwdrivers 888.4540 Udo Schilling Cnc-Drehteile Screwdriver HXX 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Screwdriver HXX 888.4540 Vilex, Inc. Screwdriver HXX Screwdriver, orthopedic. 888.4540 Warsaw Orthopedic, Inc. Screwdriver HXX 888.4540 Zimmer Holdings, Inc. Screwdriver HXX Screwdriver. 888.4540 Zimmer Spine, Inc. Screwdriver HXX Acetabular screw driver. 888.4540 Zimmer Trabecular Metal Technology Brace, Drill HXY Various types of brace. 888.4540 Biomet, Inc. Brace, Drill HXY Various models of braces,drills 888.4540 Dimeda Instrumente Gmbh Brace, Drill HXY Brace, drill 888.4540 Georg Leibinger Medizintechnischer Apparatebau Brace, Drill HXY Drill guide. 888.4540 K2m, Inc. Brace, Drill HXY 888.4540 Princeton Medical Group, Inc. Brace, Drill HXY Drill 888.4540 Rz Medizintechnik Gmbh Brace, Drill HXY A; STYLE; TAP HANDLE 888.4540 Small Bone Innovations, Inc. Brace, Drill HXY Brace, drill. 888.4540 Small Bone Innovations, Inc. Brace, Drill HXY 888.4540 Smith & Nephew Inc.- Orthopaedics Division Brace, Drill HXY Drill guide. 888.4540 Spine Smith Partners L.P. Brace, Drill HXY Brace, drill 888.4540 Vehu Medical Instrumente Gmbh Brace, Drill HXY Drill brace. 888.4540 Warsaw Orthopedic, Inc. Brace, Drill HXY 888.4540 Zimmer Holdings, Inc. Brace, Drill HXY Drill guide. 888.4540 Zimmer Trabecular Metal Technology Cutter, Wire HXZ Cutter for implants 888.4540 Baur Und Haselbarth-Chirurg Gmbh Cutter, Wire HXZ Various types of cutters. 888.4540 Biomet Microfixation Inc. Cutter, Wire HXZ Various types of wire cutters. 888.4540 Biomet, Inc. Cutter, Wire HXZ Various types of wire cutters 888.4540 Bontempi Chirurgische Instrumente Ohg Cutter, Wire HXZ Various 888.4540 Chifa Cutter, Wire HXZ Various 888.4540 Christian Diener Gmbh. & Co. K.G. Cutter, Wire HXZ Same 888.4540 Combined Instruments (Pvt.), Ltd. Cutter, Wire HXZ Replacement parts for wire cutters 888.4540 Dannoritzer Medical Instruments Cutter, Wire HXZ Screw/bolt cutter. 888.4540 Depuy Spine, Inc. Cutter, Wire HXZ Various types of orthopedic wire cutters. 888.4540 Depuy-Raynham, A Div. Of Depuy Orthopaedics Cutter, Wire HXZ Various models of cutters, wire 888.4540 Dimeda Instrumente Gmbh Cutter, Wire HXZ Various types and sizes of wire cutters 888.4540 Diwymed Production Gmbh Cutter, Wire HXZ Various 888.4540 Etablissements Boutmy S.A. Cutter, Wire HXZ Cutter, wire 888.4540 Friedrich Daniels Gmbh Cutter, Wire HXZ 888.4540 Hipp Gmbh, Anton Cutter, Wire HXZ 888.4540 Holmed Corporation Cutter, Wire HXZ Various types of wire cutters. 888.4540 Interventional Spine, Inc. Cutter, Wire HXZ Various 888.4540 K.K. Metallic Industries Cutter, Wire HXZ Cutter. 888.4540 K2m, Inc.

Source: MDRWeb.com 87 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Cutter, Wire HXZ Cutting tongs for wire. 888.4540 Kapp Chirurgische Instrumente Gmbh Cutter, Wire HXZ Various 888.4540 Kashmir Surgical Co. Cutter, Wire HXZ Wire and bolt cutters. 888.4540 Key Surgical, Inc. Cutter, Wire HXZ Ranging in size from 10in., 16in., and 22in., 888.4540 Kmedic stainless steel, end-cutting pliers cut wire up to 7mm. Cutter, Wire HXZ Wire cutter. 888.4540 Koros Usa, Inc. Cutter, Wire HXZ Various styles & styles of wire cutter 888.4540 M.F. Elahi & Co. (Ep) Pvt. Ltd. Cutter, Wire HXZ Wire cutting scissors wire pulling forceps 888.4540 Marida, Marianne Daniels Chir. Instr. Cutter, Wire HXZ 888.4540 Mattes & Schwarz Cutter, Wire HXZ 888.4540 Medicon Eg Cutter, Wire HXZ Various types of orthopedic wire cutters. 888.4540 Medtronic Sofamor Danek Instrument Manufacturing Cutter, Wire HXZ Various types of orthopedic wire cutters. 888.4540 Medtronic Sofamor Danek Usa, Inc. Cutter, Wire HXZ 888.4540 Merlyn Pharmaceuticals, Inc. Cutter, Wire HXZ Various 888.4540 Michele Cannova Chirurgische Instrumente Cutter, Wire HXZ Various types of orthopedic wire cutters 888.4540 Normed Gmbh Cutter, Wire HXZ Wire cutter 888.4540 Rainer Rosenkranz Chirurgische Instrumente Manufac Cutter, Wire HXZ Programmable cutting machine for wire, 888.4540 Schleuniger, Inc. tubing, flat ribbon, and fiberoptic cable. Cutter, Wire HXZ 888.4540 Simpex Medical, Inc. Cutter, Wire HXZ 888.4540 Small Bone Innovations, Inc. Cutter, Wire HXZ Orthopedic manual surgical instrument. 888.4540 Small Bone Innovations, Inc. Cutter, Wire HXZ 888.4540 Smith & Nephew Inc.- Orthopaedics Division Cutter, Wire HXZ Wire cutting scissors 888.4540 Stoehr Medizintechnik Cutter, Wire HXZ Full line of stainless steel & tungsten carbide 888.4540 Striker Corp. cutters. Cutter, Wire HXZ 888.4540 Stryker Corp. Cutter, Wire HXZ 888.4540 Stryker Pacific Cutter, Wire HXZ 888.4540 Stryker Spine Cutter, Wire HXZ Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Cutter, Wire HXZ Wire, pin, cutters. 888.4540 Toolmex Corporation Cutter, Wire HXZ 888.4540 Tuzik Boston Cutter, Wire HXZ 888.4540 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Cutter, Wire HXZ Wire cutter 888.4540 Vehu Medical Instrumente Gmbh Cutter, Wire HXZ Various types of orthopedic wire cutters. 888.4540 Warsaw Orthopedic, Inc. Cutter, Wire HXZ Pin, capping device, external. 888.4540 Westcon Orthopedics, Inc. Cutter, Wire HXZ 888.4540 Zimmer Holdings, Inc. Cutter, Wire HXZ Cutter. 888.4540 Zimmer Trabecular Metal Technology Forceps, Wire Holding HYA Various types of wire holding forceps. 878.4800 Biomet, Inc. Forceps, Wire Holding HYA Same 878.4800 Combined Instruments (Pvt.), Ltd. Forceps, Wire Holding HYA Micro-france 878.4800 Etablissements Boutmy S.A. Forceps, Wire Holding HYA 878.4800 J. Jamner Surgical Instruments, Inc Forceps, Wire Holding HYA Wire twisting forceps. 878.4800 Kls-Martin L.P.

Source: MDRWeb.com 88 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Forceps, Wire Holding HYA 878.4800 Kmedic Forceps, Wire Holding HYA 878.4800 Prosurge Instruments, Inc. Forceps, Wire Holding HYA Various 878.4800 Rainer Rosenkranz Chirurgische Instrumente Manufac Forceps, Wire Holding HYA Various types of bone holding forceps 878.4800 Seifring - Instrumente Gmbh. Forceps, Wire Holding HYA 878.4800 Smith & Nephew Inc.- Orthopaedics Division Forceps, Wire Holding HYA 878.4800 Smith & Nephew, Inc., Endoscopy Division Forceps, Wire Holding HYA 878.4800 Stryker Spine Forceps, Wire Holding HYA 878.4800 Toolmex Corporation Forceps, Wire Holding HYA 878.4800 Ulrich Ag Forceps, Wire Holding HYA 878.4800 Zimmer Holdings, Inc. Device Prosthesis Alignment IQO Upper & lower limb protheses. 890.3025 American Hand Prosthetics, Inc. Device Prosthesis Alignment IQO Various. 890.3025 Biomet, Inc. Device Prosthesis Alignment IQO Dero prosthetic sock. 890.3025 Capro Solutions, Llc Device Prosthesis Alignment IQO NESS H200 uses functional electrical 890.3025 Healthsouth Corporation stimulation to improve upper-extremity rehabilitation. Device Prosthesis Alignment IQO Various. 890.3025 Hosmer Dorrance Corp. Device Prosthesis Alignment IQO Supports a cast. 890.3025 Medical Industries Of America Llc. Device Prosthesis Alignment IQO Svgs-smart variable geometry socket 890.3025 Simbex, Llc accessory. Device Prosthesis Alignment IQO Various types of padding. 890.3025 Solaris, Inc. Device Prosthesis Alignment IQO Prosthetic and orthotic accessory. 890.3025 Vq Orthocare Device Prosthesis Alignment IQO Various types of cast liners. 890.3025 W.L. Gore & Associates,Inc Joint, Shoulder, External Limb IQQ Shoulder support. 890.3420 Benik Corp. Component Joint, Shoulder, External Limb IQQ Off-the-shelf shoulder braces and supports. 890.3420 DJO Inc. Component Joint, Shoulder, External Limb IQQ Axilla pad. 890.3420 Hosmer Dorrance Corp. Component Joint, Shoulder, External Limb IQQ 890.3420 Small Bone Innovations, Inc. Component Joint, Elbow, External Limb IRD Various elbow orthoses and orthosis 890.3420 Becker Orthopedic Component, Mechanical components. Appliance Co. Joint, Elbow, External Limb IRD Various. 890.3420 Hosmer Dorrance Corp. Component, Mechanical Joint, Elbow, External Limb IRD Functional elbows and joints for all levels of 890.3420 Hosmer-Dorrance Corp. Component, Mechanical upper extremity amputations. Joint, Elbow, External Limb IRE Various. 890.3420 Hosmer Dorrance Corp. Component, Powered Joint, Elbow, External Limb IRE Switch and myo control for motorized 890.3420 Hosmer-Dorrance Corp. Component, Powered elbows, prehension actuators and terminal devices. Joint, Hip, External Limb Component ISL Artificial limb hip joint. 890.3420 Endolite North America, Ltd. Joint, Hip, External Limb Component ISL Various. 890.3420 Hosmer Dorrance Corp. Joint, Hip, External Limb Component ISL PRIMALOC Total Hip System; total hip 890.3420 Ortho Development Corp. replacement. Joint, Hip, External Limb Component ISL PRO Neoprene rubber joint sleeves and 890.3420 Pro Orthopedic Devices, Inc. supports. Joint, Hip, External Limb Component ISL Capello hip positioner complete with gel 890.3420 Signal Medical Corporation pad, including 4’ positioning board, saftey clamps 9” pegs, 6” pegs, and 46” gel pad. Valve, Prosthesis ISP PANJE, Voicemaster & Grongingen. 890.3420 E. Benson Hood Laboratories, Inc.

Source: MDRWeb.com 89 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Valve, Prosthesis ISP Various. 890.3420 Hosmer Dorrance Corp. Valve, Prosthesis ISP O&p valve prosthesis. 890.3420 Orthotic & Prosthetic Lab, Inc. Valve, Prosthesis ISP 890.3420 Passy-Muir Inc. Valve, Prosthesis ISP 890.3420 Teufel Gmbh & Co. Kg Prosthesis, Thigh Socket, External ISS Lower extremity prosthesis. 890.3420 Caguas Orthopedic Center, Component Inc. Prosthesis, Thigh Socket, External ISS Prosthetic sportswear garment. 890.3420 Genuine Care Rehab. Svc., Component Inc. Prosthesis, Thigh Socket, External ISS Various. 890.3420 Hosmer Dorrance Corp. Component Prosthesis, Thigh Socket, External ISS Structural components for ankle, foot, knee 890.3420 Ohio Willow Wood Company Component and thigh prostheses.; Prosthetic Thigh Socket, multiple Prosthesis, Thigh Socket, External ISS O&p socket. 890.3420 Orthotic & Prosthetic Lab, Component Inc. Prosthesis, Thigh Socket, External ISS Socket liner. 890.3420 Trulife, Inc. Component Prosthesis, Thigh Socket, External ISS 890.3420 Vessa Ltd. Component Joint, Knee, External Limb ISY External prosthetic knee. 890.3420 Aulie Devices, Inc. Component Joint, Knee, External Limb ISY Various types of external limb components 890.3420 Bionix Development Corp. Component (knee). Joint, Knee, External Limb ISY Sleeve 890.3420 Dj Orthopedics De Mexico, Component S.A. De C.V. Joint, Knee, External Limb ISY Prosthetic limb knee joint. 890.3420 Endolite North America, Ltd. Component Joint, Knee, External Limb ISY Various models of artificial, external limb 890.3420 Hosmer Dorrance Corp. Component knee joints. Joint, Knee, External Limb ISY Modular and conventional components for 890.3420 Hosmer-Dorrance Corp. Component all levels of lower extremity amputations. Joint, Knee, External Limb ISY $653.00 and $1043.00 per unit (standard). 890.3420 Mauch, Inc. Component Joint, Knee, External Limb ISY Structural components for ankle, foot, knee 890.3420 Ohio Willow Wood Company Component and thigh prostheses.; - GeoFlex; GeoLite; Prosthetic Knee, multiple; Stabilized Knee Joint, Knee, External Limb ISY 890.3420 Ossur Americas Component Joint, Knee, External Limb ISY Various types of external knee components/ 890.3420 Otto Bock Healthcare, Lp Component accessories. Joint, Knee, External Limb ISY Various models of prosthetic knees. 890.3420 Trulife, Inc. Component Unit, Wrist, External Limb Component, ISZ Limb restraint. 890.3420 Dick Medical Supply, Llc Mechanical Unit, Wrist, External Limb Component, ISZ Various. 890.3420 Hosmer Dorrance Corp. Mechanical Unit, Wrist, External Limb Component, ISZ Functional wrists with nylon friction and 890.3420 Hosmer-Dorrance Corp. Mechanical flexion. Elbow with flexion and extension. Shoulder joints with flexion-extension, adduction abduction. Unit, Wrist, External Limb Component, ISZ 890.3420 Lighthouse Industries Mechanical Unit, Wrist, External Limb Component, ISZ Wrist hinge. 890.3420 Patterson Medical Supply, Mechanical Inc. Catheter, Infusion JCY Various types of sizes of catheters. 878.4200 Ac Healthcare Supply, Inc. Catheter, Infusion JCY Emergency infusion device, peripheral 878.4200 Arrow International, Inc. emergency infusion device, rapid infusion catheter exchange set, high-flow fluid administration set, emergency/trauma catheter and peritoneal lavage kit.

Source: MDRWeb.com 90 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter, Infusion JCY Infusion catheter. 878.4200 Boston Scientific- Neurovascular Catheter, Infusion JCY $18.00 Nova catheter 1 and 2. 878.4200 Cardiomed Supplies Inc. Catheter, Infusion JCY Introducers. 878.4200 Clinical Instruments Intl., Inc. Catheter, Infusion JCY 878.4200 Cook Inc. Catheter, Infusion JCY 878.4200 Covidien Lp Catheter, Infusion JCY MULTI-MED DOUBLE LUMEN CATHETER; 878.4200 Edwards Lifesciences, Llc. SINGLE LUMEN INFUSION CATH Catheter, Infusion JCY Infusion catheter. 878.4200 E-Z-Em, Inc. Catheter, Infusion JCY Catheter, infusion 878.4200 Gama, A.S. Catheter, Infusion JCY 878.4200 Hospira, Inc. Catheter, Infusion JCY FloStar Needleless Connector - patented 878.4200 Intravascular Incorporated “dual-valve” needle free connector for use on venous or arterial lines with luer lock or luer slip in intravenous therapy. Available stand alone or on extension sets. Catheter, Infusion JCY SOF-SET subcutaneous non-needle infusion 878.4200 Medtronic Minimed set. Catheter, Infusion JCY 878.4200 Pragoexport Catheter, Infusion JCY 878.4200 Ranfac Corp. Catheter, Infusion JCY Central catheter (sterile) 878.4200 Vygon S A Cap, Bone JDT Bone cap. 888.3000 Martin Technology, Llc Evacuator, Vapor, Cement Monomer JDY Cementation system. 888.4220 Biomet, Inc. Evacuator, Vapor, Cement Monomer JDY Various types of cement monomer vapor 888.4220 Depuy Orthopaedics, Inc. evacuators. Evacuator, Vapor, Cement Monomer JDY Evacuation & containment system. 888.4220 Niche Medical, Inc. Evacuator, Vapor, Cement Monomer JDY Cement monomer evacuator. 888.4220 Stryker Instruments, Instruments Div. Evacuator, Vapor, Cement Monomer JDY Cement monomer evacuator. 888.4220 Stryker Puerto Rico, Ltd. Evacuator, Vapor, Cement Monomer JDY 888.4220 Zimmer Holdings, Inc. Mixer, Cement, for Clinical Use JDZ Bone cement mixer and dispenser. 888.4210 Advanced Biomaterial Systems, Inc. Mixer, Cement, for Clinical Use JDZ Various types of cement mixers for clinical 888.4210 Depuy Orthopaedics, Inc. use. Mixer, Cement, for Clinical Use JDZ 888.4210 DFine Inc. Mixer, Cement, for Clinical Use JDZ 888.4210 Donatelle Mixer, Cement, for Clinical Use JDZ Cement mixer. 888.4210 Medtronic Spine Llc Mixer, Cement, for Clinical Use JDZ Various mixing bowls. 888.4210 Pac-Dent Intl., Inc. Mixer, Cement, for Clinical Use JDZ Bone cement mixer. 888.4210 Precision Medical Devices, Inc. Mixer, Cement, for Clinical Use JDZ 888.4210 Smith & Nephew Inc.- Orthopaedics Division Mixer, Cement, for Clinical Use JDZ 888.4210 Stryker Corp. Mixer, Cement, for Clinical Use JDZ Cement mixers for clinical use. 888.4210 Stryker Instruments, Instruments Div. Mixer, Cement, for Clinical Use JDZ Cement mixers for clinical use. 888.4210 Stryker Puerto Rico, Ltd. Mixer, Cement, for Clinical Use JDZ 888.4210 Stryker Spine Mixer, Cement, for Clinical Use JDZ Cement mixer. 888.4210 Synthes (Usa) - Development Center Mixer, Cement, for Clinical Use JDZ 888.4210 Zimmer Holdings, Inc. Table, Surgical with Orthopedic JEB Orthopedic table for all types of surgical 878.4950 Bryton Corp. Accessories, Manual orthopedic procedures. Table, Surgical with Orthopedic JEB 878.4950 Citow Cervical Visualizer Accessories, Manual Company Table, Surgical with Orthopedic JEB Low x-ray absorption, high strength carbon 878.4950 Composiflex, Inc. Accessories, Manual fiber surgical table tops.

Source: MDRWeb.com 91 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Table, Surgical with Orthopedic JEB 878.4950 Elmed, Inc. Accessories, Manual Table, Surgical with Orthopedic JEB $685.00 per unit (standard). Also available 878.4950 Frank Scholz X-Ray Corp. Accessories, Manual standard CLARK socket and combination CLARK socket fixation devices for standard orthopedic and surgical table side rails. Table, Surgical with Orthopedic JEB Knee positioner. 878.4950 General Hospital Supply Accessories, Manual Corp. Table, Surgical with Orthopedic JEB Tilt table. 878.4950 Hugh’s Company Accessories, Manual Table, Surgical with Orthopedic JEB Surgical table that attaches to O.R. table; 878.4950 Instrument Specialists, Inc. Accessories, Manual optically pure for X-rays. Traction system, pads and other accessories available. Table, Surgical with Orthopedic JEB 878.4950 Md International, Inc. Accessories, Manual Table, Surgical with Orthopedic JEB Remanufactured units - 2 yr warranty. 878.4950 Medrecon, Inc. Accessories, Manual Table, Surgical with Orthopedic JEB Ovation table. PROfx Table 878.4950 Mizuho Osi Accessories, Manual Table, Surgical with Orthopedic JEB 878.4950 Quatro Composites Accessories, Manual Table, Surgical with Orthopedic JEB CHICK CLT Orthopedic and Surgical 878.4950 Schaerer Mayfield Usa Accessories, Manual Operating Table. CHICK IOT Imagable Orthopedic Table. CHICK 703 Orthopedic & Surgical Operating Table. Table, Surgical with Orthopedic JEB 878.4950 Siemens Medical Solutions Accessories, Manual Usa, Inc. Table, Surgical with Orthopedic JEB 878.4950 Smith & Nephew Inc.- Accessories, Manual Orthopaedics Division Table, Surgical with Orthopedic JEB 878.4950 Stryker Medical Accessories, Manual Table, Surgical with Orthopedic JEB TELOS O.R. table extension for orthopedic 878.4950 Telos Medical Equipment Accessories, Manual surgery of the hip, pelvis, and lower (Austin & Assoc., Inc.) extremities. Table, Surgical with Orthopedic JEB Hip and knee positioner. 878.4950 White Surgical, Inc. Accessories, Manual Table, Surgical with Orthopedic JEB Specialize in refurbished OR tables such as 878.4950 World Medical Equipment, Accessories, Manual AMSCO/Steris, OEC, OSI, and Chick as well Inc. as lights, autoclaves, anesthesia machines, monitors, and accessories. Valve, Switching (Ploss) JFE Instant flow valve. 868.1965 Precision Medical, Inc. Pump, Nebulizer, Electrically Powered JPW 874.5220 Allied Healthcare Products, Inc. Pump, Nebulizer, Electrically Powered JPW Pump, nebulizer, electrically powered 874.5220 Damedco S.A. Pump, Nebulizer, Electrically Powered JPW Nebulizer. 874.5220 Gardner Denver Thomas Inc. Pump, Nebulizer, Electrically Powered JPW Foam air mattress. 874.5220 Genadyne Biotechnologies, Inc. Pump, Nebulizer, Electrically Powered JPW Nebulizer. 874.5220 Heyer America, Inc. Pump, Nebulizer, Electrically Powered JPW nebulizer system, PARI - nebulizers, infusion 874.5220 Medasto B.V. pumps, and anti-prespirant device. Pump, Nebulizer, Electrically Powered JPW Nebulizer unit for 3 persons 874.5220 Nagashima Medical Instruments Co., Ltd. Pump, Nebulizer, Electrically Powered JPW 874.5220 Precision Medical, Inc. Prosthesis, Breast, External, Used with KCZ 878.3800 Airway Division Of Surgical Adhesive Appliance Industries, Inc. Prosthesis, Breast, External, Used with KCZ Silicone & polyurethane. 878.3800 Amoena Adhesive Prosthesis, Breast, External, Used with KCZ No common name listed 878.3800 Anita Gmbh Adhesive Prosthesis, Breast, External, Used with KCZ Breast prostheses 878.3800 Anita Intl. Dr. Helbig Gmbh Adhesive & Co.

Source: MDRWeb.com 92 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Prosthesis, Breast, External, Used with KCZ BOSOM BUDDY All-fabric (contains 878.3800 B & B Lingerie Company, Inc. Adhesive no silicone or rubber), fully weighted, adjustable external breast prosthesis. Prosthesis, Breast, External, Used with KCZ 878.3800 Coloplast Manufacturing Adhesive Us, Llc Prosthesis, Breast, External, Used with KCZ External breast prosthesis (various models) 878.3800 Dekumed Gmbh Adhesive Prosthesis, Breast, External, Used with KCZ Breast prostheses 878.3800 Dr. Helbig Gmbh & Co. Adhesive Orthopaedische Produkte Kg Prosthesis, Breast, External, Used with KCZ 878.3800 Finebrand Co. Adhesive Prosthesis, Breast, External, Used with KCZ Temporary weighted breast forms and 878.3800 Freeman Manufacturing Adhesive silicone breast forms. Company Prosthesis, Breast, External, Used with KCZ Bras and prosthetics for mastectomy 878.3800 Jodee, Inc. Adhesive patients. Prosthesis, Breast, External, Used with KCZ Breast prostheses, breast form. 878.3800 La Charme Llc Adhesive Prosthesis, Breast, External, Used with KCZ Prosthetic Camisole 878.3800 Ladies First, Inc. Adhesive Prosthesis, Breast, External, Used with KCZ Custom breast prosthesis. 878.3800 Medical Art Resources, Inc. Adhesive Prosthesis, Breast, External, Used with KCZ 878.3800 Medimex Gmbh & Co. Kg Adhesive Prosthesis, Breast, External, Used with KCZ Breast prosthesis. 878.3800 Nearly Me Technologies, Inc. Adhesive Prosthesis, Breast, External, Used with KCZ Prosthesis, breast, external. 878.3800 Saville 1300, Inc. Adhesive Prosthesis, Breast, External, Used with KCZ External breast forms 878.3800 Sodipromm Sarl Adhesive Prosthesis, Breast, External, Used with KCZ Airway Division Post-Mastectomy products. 878.3800 Truform Orthotics & Adhesive Prosthetics Accessories, Catheter KGZ MEDIWINDER catheter winding and 878.4200 Acorn Equipment Co. Ltd. assembly equipment. Accessories, Catheter KGZ Wide array of accessories including 878.4200 Angiodynamics, Inc. guidewires, introducer needles, dilators, caps, clips, ties/tie guns, fluid barriers, and forceps. Accessories, Catheter KGZ RITA STARBURST ACCESS SYSTEM 878.4200 Angiodynamics, Inc. Accessories, Catheter KGZ Sterile closed surgical wound drains. 878.4200 Bacterin International Inc. Accessories, Catheter KGZ G-U - Irrigation Cap w/Syringe Tip 878.4200 Baxter Healthcare Corporation, Medication Delivery Accessories, Catheter KGZ Dialysis catheter accessories: IMMOBILIZER 878.4200 Baxter Healthcare catheter stabilizing device, locking titanium Corporation, Renal adapter. BETA-CAP adapter, locking cap for Baxter peritoneal dialysis catheter adapter. Accessories, Catheter KGZ Continuous flush and other catheter 878.4200 Becton Dickinson Infusion accessories. Therapy Systems, Inc. Accessories, Catheter KGZ #444 catheter clamp. 878.4200 Better Parts Co. Accessories, Catheter KGZ Tube holder. 878.4200 Bioderm, Inc. Accessories, Catheter KGZ Drainage catheter. 878.4200 Blue Sky Medical Group Incorporated Accessories, Catheter KGZ 878.4200 Boston Scientific - Maple Grove Accessories, Catheter KGZ 878.4200 Boston Scientific Corporation Accessories, Catheter KGZ Catheter trays up to 66in. long. 878.4200 Brentwood Industries, Inc. Accessories, Catheter KGZ Same 878.4200 Bruno & Andreas Kohler Medizintechnik Gbr. Accessories, Catheter KGZ 878.4200 C. R. Bard, Inc., Bard Medical Div. Accessories, Catheter KGZ 878.4200 C. R. Bard, Inc., Bard Urological Div.

Source: MDRWeb.com 93 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Accessories, Catheter KGZ DualCap 878.4200 Catheter Connections Inc. Accessories, Catheter KGZ 878.4200 Centurion Medical Products Corp. Accessories, Catheter KGZ Various connectors and catheter 878.4200 Deroyal Surgical - Rose Hill accessories. Accessories, Catheter KGZ Catheter straps 878.4200 Dj Orthopedics De Mexico, S.A. De C.V. Accessories, Catheter KGZ Cholangiogram Catheters 878.4200 Dma Med-Chem Corporation Accessories, Catheter KGZ PTCA accessory kit includes Excel-9 large 878.4200 Excel Medical Products, Llc bore hemostatic y-connector, guidewire insertion tool and torque device. Accessories, Catheter KGZ 878.4200 Exelint International Co. Accessories, Catheter KGZ 878.4200 Filtrona Extrusion, Inc./ PexcoÂ® Medical Products Div. Accessories, Catheter KGZ IV catheter vent. 878.4200 Genpore, A Division Of General Polymeric Corp. Accessories, Catheter KGZ 878.4200 Haemonetics Corp. Accessories, Catheter KGZ Valves for Foley catheters, endotracheal 878.4200 Halkey-Roberts Corp. tubes, and I.V. applications. Accessories, Catheter KGZ 878.4200 Iberhospitex S.A. Accessories, Catheter KGZ 878.4200 Integra Lifesciences Holdings Corp. Accessories, Catheter KGZ Catheter mounts and patient elbow 878.4200 Intersurgical Inc. connections. Accessories, Catheter KGZ 878.4200 Intravascular Incorporated Accessories, Catheter KGZ Jelco* intermittent injection cap 878.4200 Johnson & Johnson De Monterrey, Sa De Cv Accessories, Catheter KGZ Catheter insertion trays. 878.4200 Kentron Health Care, Inc. Accessories, Catheter KGZ Aspiration/infiltration tubing. 878.4200 Kmi Kolster Methods, Inc. Accessories, Catheter KGZ 878.4200 Lifemed Of California Accessories, Catheter KGZ 878.4200 M & I Medical Sales, Inc. Accessories, Catheter KGZ 878.4200 Medicus Technologies Accessories, Catheter KGZ 878.4200 Medovations, Inc. Accessories, Catheter KGZ Quick Snap(tm) Connector Set; Alows for a 878.4200 Merlin’s Medical Supply quick connect/disconnect of the GeeWhiz Condom Catheter, as well as a tubing connector for other medical and consumer product uses. Accessories, Catheter KGZ Touhy burst adapters, and catheter and 878.4200 Micor, Inc. needle guards (LDPE, HDPE, PVC). Accessories, Catheter KGZ Various sterile catheter accessories.; 878.4200 Navilyst Medical MULTIPLE Accessories, Catheter KGZ Accessories, catheter. 878.4200 Neo Medical Inc. Accessories, Catheter KGZ Connectors - KWIK-OFF, parallel Ys, Ys, 878.4200 Novosci Corp. straight and reducers. Accessories, Catheter KGZ 878.4200 Rose Technologies Company Accessories, Catheter KGZ DERMIVEX 878.4200 Smith & Nephew, Inc. Accessories, Catheter KGZ REPOSITIONING SLEEVE 878.4200 St. Jude Medical Atrial Fibrillation Accessories, Catheter KGZ Connectors; ICDs. 878.4200 St. Jude Medical, Inc. Accessories, Catheter KGZ 878.4200 Symbios Medical Products, Llc Accessories, Catheter KGZ 878.4200 Telios Pharmaceuticals Accessories, Catheter KGZ Contamination / repositioning sleeve. 878.4200 Thomas Medical Products, Inc. Accessories, Catheter KGZ 878.4200 Tri-State Hospital Supply Corp.

Source: MDRWeb.com 94 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Accessories, Catheter KGZ 878.4200 Tua Systems, Inc. Accessories, Catheter KGZ 878.4200 Vernay Laboratories, Inc. Accessories, Catheter KGZ Catheter removal kits. 878.4200 Vygon Corp. Dispenser, Cement KIH Cement dispenser. 888.4200 Abbott Spine, Inc. Dispenser, Cement KIH Bone cement mixer and dispenser. 888.4200 Advanced Biomaterial Systems, Inc. Dispenser, Cement KIH 888.4200 Codman & Shurtleff, Inc Dispenser, Cement KIH Various types of cement dispensers. 888.4200 Depuy Orthopaedics, Inc. Dispenser, Cement KIH Various types of cement dispensers. 888.4200 Depuy-Raynham, A Div. Of Depuy Orthopaedics Dispenser, Cement KIH SPACE 360 Delivery System; StabiliT Vertebral 888.4200 DFine Inc. Augmentation Sys Dispenser, Cement KIH Various 888.4200 Howmedica International S. De R.L., Dispenser, Cement KIH Bone cement delivery system. 888.4200 Integra Lifesciences Corp. Dispenser, Cement KIH Dispenser, cement. 888.4200 Medtronic Puerto Rico Operations Co.,Med Rel Dispenser, Cement KIH Dispenser, cement. 888.4200 Medtronic Sofamor Danek Usa, Inc. Dispenser, Cement KIH Various. 888.4200 Medtronic Spine Llc Dispenser, Cement KIH Cement dispenser. 888.4200 Orthovita, Inc. Dispenser, Cement KIH OsseoFlex 1.0 Steerable Needle 888.4200 Osseon Therapeutics, Inc. Dispenser, Cement KIH Bone cement gun, nozzle and restrictor 888.4200 Precision Medical Devices, plug. Inc. Dispenser, Cement KIH Syringe. 888.4200 Skeletal Kinetics, Llc Dispenser, Cement KIH Various types of cement dispensers and 888.4200 Spine Wave, Inc. accessories. Dispenser, Cement KIH 888.4200 Spineworks Medical Inc. Dispenser, Cement KIH Cement dispenser and various sterile 888.4200 Stryker Instruments, accessories. Instruments Div. Dispenser, Cement KIH Cement dispenser and various sterile 888.4200 Stryker Puerto Rico, Ltd. accessories. Dispenser, Cement KIH Cement dispenser. 888.4200 Synthes (Usa) - Development Center Dispenser, Cement KIH Dispenser, cement. 888.4200 Warsaw Orthopedic, Inc. Tube, Cement Ventilation KII Vent tubing. 888.4230 Biomet, Inc. Positioner, Socket KIL 888.4540 Alimed, Inc. Positioner, Socket KIL Positioning device for shoulder 888.4540 Allen Medical Systems, Inc. Positioner, Socket KIL Tongue positioner and excerciser,tongue 888.4540 Allesee Orthodontic positioner and exerciser palate. Appliances Positioner, Socket KIL 888.4540 Andronic Devices Positioner, Socket KIL Pactan positioning device 888.4540 Kaltec Pty. Ltd. Positioner, Socket KIL Positioner for the anchorage cruciform 888.4540 S.P.O.R.T. component Positioner, Socket KIL Positioner. 888.4540 Tri-Medics, Inc. Positioner, Socket KIL Head rest. 888.4540 Voss Medical Products Positioner, Socket KIL Retractors. 888.4540 Zimmer Trabecular Metal Technology Media and Components, Synthetic KIT Tissue culture media. 864.2220 Diagnostic Hybrids, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT Various (serum-free). 864.2220 Hyclone Laboratories, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT M3 family of media. 864.2220 Incell Corporation, Llc Cell And Tissue Culture Media and Components, Synthetic KIT EUTROPH serum, media and cells for tissue 864.2220 Laboratoires Eurobio Cell And Tissue Culture culture.

Source: MDRWeb.com 95 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Media and Components, Synthetic KIT Culture media 864.2220 Laboratoires Prodimed Cell And Tissue Culture Media and Components, Synthetic KIT 864.2220 Lonza Walkersville, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT 864.2220 Mediatech, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT Tissue culture containers. 864.2220 Millipore Corporation Cell And Tissue Culture Media and Components, Synthetic KIT Animal and human sera. 864.2220 Nova-Tech, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT Poh disclosing wafers. 864.2220 Oral Health Products, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT Same 864.2220 Paa Laboratories Gmbh Cell And Tissue Culture Media and Components, Synthetic KIT Various. 864.2220 Safc Biosciences, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT 864.2220 Safc Biosciences, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT Media and components, synthetic cell and 864.2220 Scytek Laboratories, Inc. Cell And Tissue Culture tissue culture. Media and Components, Synthetic KIT Various synthetic cell and tissue cultures. 864.2220 Sigma-Aldrich Cell And Tissue Culture Manufacturing, Llc. Media and Components, Synthetic KIT Terumo sensibead eia progesterone kit. 864.2220 Terumo Medical Corporation Cell And Tissue Culture Media and Components, Synthetic KIT Vascular Endothelial Cells 864.2220 Vec Technologies, Inc. Cell And Tissue Culture Media and Components, Synthetic KIT Various formulations of liquid tissue culture 864.2220 Viromed Laboratories Cell And Tissue Culture media. (Labcorp) Device, Intravascular Catheter KMK 880.5210 3m Company Securement Device, Intravascular Catheter KMK 880.5210 Centurion Medical Products Securement Corp. Device, Intravascular Catheter KMK VENI-GARD IV Secure device which secures 880.5210 ConMed Corporation Securement IV tubing to patient. Device, Intravascular Catheter KMK Various sizes of i.v. transparent dressings. 880.5210 Corium International, Inc. Securement Device, Intravascular Catheter KMK I.V. house. 880.5210 Four Process, Ltd. Securement Device, Intravascular Catheter KMK I.v. armboards. 880.5210 Genesis Medical Products, Securement Inc. Device, Intravascular Catheter KMK Various. 880.5210 Health Care Logistics, Inc. Securement Device, Intravascular Catheter KMK I.V. HOUSE ULTRA DRESSING--intravenous site 880.5210 I.V. House, Inc. Securement protector. Device, Intravascular Catheter KMK Anchor bandage. 880.5210 K. W. Griffen Co. Securement Device, Intravascular Catheter KMK Tube-securing device. LineBacker is 880.5210 Martin-Mars, Inc. Securement a tapeless device that secures the intravenous line in severe and harsh conditions. Ideal for the emergency environment as well as combat conditions. Device, Intravascular Catheter KMK Intravascular catheter securement device. 880.5210 Medtronic Ep Systems Securement Device, Intravascular Catheter KMK I/v guard. 880.5210 Modern Medical Technology, Securement Inc. Device, Intravascular Catheter KMK Iv dressing, sterile 880.5210 Molnlycke Health Care, Oy Securement Device, Intravascular Catheter KMK Site securement device. 880.5210 Nexus Medical, Llc Securement Device, Intravascular Catheter KMK Peripheral line dressing 880.5210 Niko Medical Products Securement

Source: MDRWeb.com 96 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Device, Intravascular Catheter KMK I.V. cover or I.V. guard. 880.5210 Pedia Pals, Llc Securement Device, Intravascular Catheter KMK Catheter bandage-cover dressing. 880.5210 R4 Vascular, Inc. Securement Device, Intravascular Catheter KMK SecureIt Nasal and Catheter Tube Holders 880.5210 Sterion, Incorporated Securement to standardize fastening procedures and hold catheters securely in place. Device, Intravascular Catheter KMK 880.5210 Tri-State Hospital Supply Securement Corp. Device, Intravascular Catheter KMK Various. 880.5210 Venetec International., Inc. Securement Device, Intravascular Catheter KMK 880.5210 Wv Iv Pro, Inc. Securement Device, Intravascular Catheter KMK Grip-Lok Universal Securement Device 880.5210 Zefon International Securement secures various tubes to patients. Sizes available to hold tubes from .8mm to 19mm. Catheter, Rectal For Continent KPH Continent iliostomy catheter. 876.5030 Ac Healthcare Supply, Inc. Ileostomy Catheter, Rectal For Continent KPH 876.5030 Zassi Medical Evolutions, Inc. Ileostomy Goniometer, Non-Powered KQW Acumar inclinometer. 888.1520 Acumar Technology Goniometer, Non-Powered KQW 888.1520 Alimed, Inc. Goniometer, Non-Powered KQW Various types of goniometers. 888.1520 Biomet Microfixation Inc. Goniometer, Non-Powered KQW Various types of goniometer. 888.1520 Biomet, Inc. Goniometer, Non-Powered KQW Goniometer. 888.1520 Depuy Spine, Inc. Goniometer, Non-Powered KQW Goniometer 888.1520 Dongguan Xie Gang Kongloon Metal Plastic Mfy. Goniometer, Non-Powered KQW Dynastat 888.1520 Dynastat Biomechanics Goniometer, Non-Powered KQW Non-powered goniometer. 888.1520 Fabrication Enterprises Inc. Goniometer, Non-Powered KQW Hand-operated goniometer 888.1520 Nagashima Medical Instruments Co., Ltd. Goniometer, Non-Powered KQW Goniometer. 888.1520 Patterson Medical Supply, Inc. Goniometer, Non-Powered KQW Goniometer, nonpowered. 888.1520 Plasticards, Inc. Dba Rainbow Printing Co. Goniometer, Non-Powered KQW 888.1520 Princeton Medical Group, Inc. Goniometer, Non-Powered KQW Goniometer. 888.1520 Richardson Products, Inc. Goniometer, Non-Powered KQW Nonpowered goniometer/orthopedic 888.1520 Rudolf Storz Gmbh goniometer Goniometer, Non-Powered KQW Ligmaster. 888.1520 Sport Tech, Inc. Goniometer, Non-Powered KQW Inclinometer. 888.1520 The Saunders Group Goniometer, AC-powered KQX Motion analysis system (3d-dynamic range- 888.1500 Advanced Motion of-motion). Measurement, Llc Goniometer, AC-powered KQX 888.1500 Dynatronics Corp. Goniometer, AC-powered KQX SPINAL TOUCH Computerized inclinometer 888.1500 Fasstech for spinal range-of-motion and impairment rating. Goniometer, AC-powered KQX 888.1500 Global Services Group Goniometer, AC-powered KQX Spinalmouse 888.1500 Idiag Goniometer, AC-powered KQX 888.1500 JTECH Medical Goniometer, AC-powered KQX Various types of goniometers and 888.1500 Jtech Medical inclinometers. Goniometer, AC-powered KQX Motus movement monitor. 888.1500 Motus Bioengineering Inc. Goniometer, AC-powered KQX Goniometer with control box, electric 888.1500 Nagashima Medical Instruments Co., Ltd. Goniometer, AC-powered KQX Ac powered goniometer. 888.1500 Nk Biotechnical Corp. Goniometer, AC-powered KQX Knee positioning and alignment system. 888.1500 Ppi-Time Zero Inc.

Source: MDRWeb.com 97 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Goniometer, AC-powered KQX Goniometer contact angle measurement, 888.1500 Ramé-Hart, Inc. wetting, surface tension. Component, Traction, Non-Invasive KQZ Various. 888.5890 Arthrex, Inc. Component, Traction, Non-Invasive KQZ Vertebral distraction pump (v.d.p.). 888.5890 Bray Corporation Component, Traction, Non-Invasive KQZ Cervical traction device. 888.5890 Care Rehab And Orthopaedic Products, Inc. Component, Traction, Non-Invasive KQZ Shoulder trac. 888.5890 Cimex Medical Innovations, Llc Component, Traction, Non-Invasive KQZ Various non-invasive traction components, 888.5890 Deroyal Surgical - Rose Hill sterile and non-sterile. Component, Traction, Non-Invasive KQZ HEELIFT® TRACTION BOOT provides the 888.5890 Dm Systems, Inc. same heel pressure relief and added benefits of the existing Heelift® products while preventing fracture pain with up to ten pounds of straight skin traction. The Velcro® traction straps can be removed for continued re Component, Traction, Non-Invasive KQZ 888.5890 Ossur Americas Component, Traction, Non-Invasive KQZ RYCOR Finger Traps mesh fabric gripping 888.5890 Rycor Medical, Inc. device to apply traction on upper extremities. Component, Traction, Non-Invasive KQZ Pelvic sling, circumferential sacroiliac sling 888.5890 Sam Medical Products orthosis. Component, Traction, Non-Invasive KQZ Non-invasive traction component. 888.5890 Smith & Nephew Inc., Endoscopy Div. Component, Traction, Non-Invasive KQZ Traction device. 888.5890 The Saunders Group Component, Traction, Non-Invasive KQZ Traction belt, harness. 888.5890 Vmg Medical, Inc. Accessory Equipment, KRI Frogger pad naturally flexes legs and offers 870.4200 Allen Medical Systems, Inc. Cardiopulmonary Bypass a stable platform on which to perform saphenous vein removal. Accessory Equipment, KRI Cardiopulmonary bypass device holders 870.4200 Ashitaka Factory Of Terumo Cardiopulmonary Bypass Corporation Accessory Equipment, KRI Tourniquet set, coronary artery probes, 870.4200 Atek Medical Cardiopulmonary Bypass coronary artery occluders. Accessory Equipment, KRI Temperature monitoring probe. 870.4200 Chase Medical, Lp Cardiopulmonary Bypass Accessory Equipment, KRI HI-TEMP MYOCARDIAL 870.4200 Covidien Cardiopulmonary Bypass Accessory Equipment, KRI Bone Wax and Cotton Umbilical Tape 870.4200 Cp Medical Corporation Cardiopulmonary Bypass Accessory Equipment, KRI Sterile bowls. 870.4200 Deroyal Surgical - Rose Hill Cardiopulmonary Bypass Accessory Equipment, KRI Various 870.4200 Dideco S.P.A. Cardiopulmonary Bypass Accessory Equipment, KRI Tubing organizer. 870.4200 International Biophysics Corp. Cardiopulmonary Bypass Accessory Equipment, KRI Various types of cardiopulmonary bypass 870.4200 Jostra Bentley, Inc. Cardiopulmonary Bypass device holder. Accessory Equipment, KRI 870.4200 Medtronic Perfusion Systems Cardiopulmonary Bypass Accessory Equipment, KRI Pressure monitor. 870.4200 Minntech Corporation Cardiopulmonary Bypass Accessory Equipment, KRI Myocardial temperature sensor 870.4200 Mmj S.A. De C.V. Cardiopulmonary Bypass Accessory Equipment, KRI 870.4200 Plastic And Metal Center, Inc. Cardiopulmonary Bypass Accessory Equipment, KRI Pressure relief valve. 870.4200 Terumo Cardiovascular Cardiopulmonary Bypass Systems (Tcvs) Accessory Equipment, KRI 870.4200 Terumo Cardiovascular Cardiopulmonary Bypass Systems, Corp Caliper KTZ Caliper. 888.4150 Abbott Spine, Inc. Caliper KTZ “Accu-measure.” 888.4150 Accu-Measure, Llc

Source: MDRWeb.com 98 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Caliper KTZ 888.4150 Alimed, Inc. Caliper KTZ Sizing block. 888.4150 Arthrex, Inc. Caliper KTZ Various types of caliper. 888.4150 Biomet, Inc. Caliper KTZ Caliper/orchometer. 888.4150 Dalzell Usa Medical Systems Caliper KTZ Decimal caliper lwanson for metal. 888.4150 Den Tag S.R.L. Caliper KTZ Caliper. 888.4150 Dental Usa, Inc. Caliper KTZ Caliper. 888.4150 Depuy Spine, Inc. Caliper KTZ Various types of caliper, orthopedic 888.4150 Hall & Scheier Caliper KTZ DIGITAL. Stores and totalise patient’s 888.4150 Healthtronics Service Center individual measurements (up to 19 per patient) and store up to 255 patients. Caliper KTZ Caliper. 888.4150 In’Tech Medical, Incorporated Caliper KTZ Caliper. 888.4150 K2m, Inc. Caliper KTZ Calipers use 888.4150 Marida, Marianne Daniels Chir. Instr. Caliper KTZ Calipers for metal or wax. 888.4150 Motloid Company Caliper KTZ DEFEND. 888.4150 Mydent International Caliper KTZ Caliper for medical use. 888.4150 Nk Biotechnical Corp. Caliper KTZ 888.4150 Radiation Products Design, Inc. Caliper KTZ Various 888.4150 Rudolf Storz Gmbh Caliper KTZ Various types of calipers and measuring 888.4150 Salvin Dental Specialties, Inc. devices. Caliper KTZ Various types of calipers, caliper orthopedic 888.4150 Schad Medical Instruments Gmbh Caliper KTZ Caliper 888.4150 Smt Schilling Metalltechnik Gmbh Caliper KTZ Calipers for measuring bone grafts and 888.4150 West Coast Surgical Llc. implant size. Caliper KTZ Caliper. 888.4150 Zimmer Trabecular Metal Technology Component, Cast LGF Cast component. 888.5940 Ac Healthcare Supply, Inc. Component, Cast LGF Various vacuum bag and low melt plastic 888.5940 Bionix Development Corp. cast supports. Component, Cast LGF 888.5940 Cml Consortium De Materiel Pour Lab. Component, Cast LGF Various types of plasters. 888.5940 Debusk Orthopedic Casting (Doc) Component, Cast LGF Cast component 888.5940 Dj Orthopedics De Mexico, S.A. De C.V. Component, Cast LGF Cast component 888.5940 Dj Orthopedics De Mexico, S.A. De C.V. Component, Cast LGF CASTWEDGE™ CAST ADJUSTER is utilized to 888.5940 Dm Systems, Inc. hold open a uni-or bi-valved cast for control of swelling. It also enhances standard open wedging techniques. The CastWedge™ comes in five different sizes for greater flexibility in treatment (10mm, 15mm, 20mm, 25 Component, Cast LGF 888.5940 Hartmann Ag, Paul Component, Cast LGF 888.5940 Holthaus Medical Gmbh & Co. Kg Component, Cast LGF 888.5940 Homann Medical Gmbh & Co. Kg Component, Cast LGF Various sizes of casting tapes 888.5940 Huang Yan Medical Supply Factory Component, Cast LGF Cast-removal instrument and supplies. 888.5940 International Hospital Supply Co.

Source: MDRWeb.com 99 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Component, Cast LGF Various types cast components. 888.5940 Just Packaging Inc. Component, Cast LGF Under cast padding. 888.5940 Medline Manufacturing And Services Llc Component, Cast LGF 888.5940 Ossur Americas Component, Cast LGF 888.5940 Pedinol Pharmacal, Inc. Component, Cast LGF Casting accessories. 888.5940 Protectair Inc. Component, Cast LGF X-LITE thermoplastic synthetic cast, splints, 888.5940 Runlite Sa stockinettes, foams. Component, Cast LGF 888.5940 Smith & Nephew Plc. Component, Cast LGF Various 888.5940 Smith & Nephew, Mexico Inc. Component, Cast LGF Various. 888.5940 Stryker Instruments, Instruments Div. Component, Cast LGF Component cast. 888.5940 Sukol Scientific, Inc. Component, Cast LGF TEX-CARE natural and synthetic cast 888.5940 Tex-Care Medical padding. Padding component in orthopedic casting and orthopedic appliances. Component, Cast LGF Cast liner. 888.5940 W.L. Gore & Associates,Inc Instrument, Cast Application/ LGG Various types of manual cast removel 888.5980 Biomet, Inc. removal, Manual instruments. Instrument, Cast Application/ LGG Various 888.5980 Chifa removal, Manual Instrument, Cast Application/ LGG Various models of of instruments 888.5980 Dimeda Instrumente Gmbh removal, Manual Instrument, Cast Application/ LGG Various types of cast application/removal 888.5980 Gebrueder Zepf removal, Manual instruments, manual Instrument, Cast Application/ LGG Orthopedic Devices, CastStand is designed 888.5980 Medtech Systems removal, Manual to aid in the application of short or long leg cast for use in the hospital, office or nursing home. Instrument, Cast Application/ LGG 888.5980 Ortho-Med, Inc. removal, Manual Instrument, Cast Application/ LGG Instrument, cast application/removal, 888.5980 Richard Gut Chir. Instrumente removal, Manual manual Gmbh Instrument, Cast Application/ LGG Manual cast application/removal 888.5980 Stryker Instruments, removal, Manual instrument. Instruments Div. Instrument, Cast Application/ LGG Instrument, cast application/removal, 888.5980 Vehu Medical Instrumente removal, Manual manual Gmbh Instrument, Cast Application/ LGG Cast removal aid. 888.5980 W.L. Gore & Associates,Inc removal, Manual Instrument, Cast Removal, AC- LGH 888.5960 Alimed, Inc. Powered Instrument, Cast Removal, AC- LGH Various. 888.5960 Bsn Medical, Inc. Powered Instrument, Cast Removal, AC- LGH Powered cast saw. 888.5960 Debusk Orthopedic Casting Powered (Doc) Instrument, Cast Removal, AC- LGH Various models ofinstruments cast removal 888.5960 Dimeda Instrumente Gmbh Powered ac powered Instrument, Cast Removal, AC- LGH Cast cutter. 888.5960 Elite Medical Equipment Powered Instrument, Cast Removal, AC- LGH 888.5960 Her-Mar, Inc. Powered Instrument, Cast Removal, AC- LGH Cast cutter saw; plaster saw 888.5960 Oscitronic S.A. Powered Instrument, Cast Removal, AC- LGH Various 888.5960 Ricana Ag Medical Systems Powered Instrument, Cast Removal, AC- LGH Various electric cast vacuums and 888.5960 Stryker Instruments, Powered accessories. Instruments Div. Face Plate Hearing Aid LRB Various types of prewired hearing aid 874.3300 Affinity Medical Technology, faceplates. Llc.

Source: MDRWeb.com 100 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Face Plate Hearing Aid LRB Various face plate hearing aids. 874.3300 America Hears, Inc. Face Plate Hearing Aid LRB Multiple (alpha, image) 874.3300 American Hearing Systems prolink,quiklink,quiklink d,diglink. Inc. Face Plate Hearing Aid LRB 874.3300 Audina Hearing Instruments, Inc. Face Plate Hearing Aid LRB Hearing aid. 874.3300 Crystal Tone Hearing Instruments Face Plate Hearing Aid LRB Various models of faceplates 874.3300 Gn Resound Face Plate Hearing Aid LRB Various types of hearing aids. 874.3300 House Of Hearing Face Plate Hearing Aid LRB Master craft laboratories. 874.3300 Master Craft Labs Face Plate Hearing Aid LRB Audio enhancer in-the-ear (ite), audio 874.3300 Midwest City Hearing Aid enhancer in-the-canal (itc) & audio enhan. Center Face Plate Hearing Aid LRB Faceplate hearing aid. 874.3300 Stephen Tobias Hearing Center Orthopedic Manual Surgical LXH Various orthopedic manual surgical 888.4540 3d Medical Concepts, Llc Instrument instruments. Orthopedic Manual Surgical LXH 888.4540 A.M. Surgical, Inc. Instrument Orthopedic Manual Surgical LXH Access needle. 888.4540 Advanced Biomaterial Instrument Systems, Inc. Orthopedic Manual Surgical LXH Pusher. 888.4540 Advanced Bio-Surfaces, Inc. Instrument Orthopedic Manual Surgical LXH Various types of surgical instruments. 888.4540 Advanced Orthopaedic Instrument Solutions, Inc. Orthopedic Manual Surgical LXH Double ended foraminal probe; posterior 888.4540 Advanced Spine Technology, Instrument disc evacuator. Inc. Orthopedic Manual Surgical LXH Orthosis manual surgical instrument. 888.4540 Aesculap Implant Systems, Instrument Inc. Orthopedic Manual Surgical LXH Various types of non-sterile orthopedic 888.4540 Alexandria Research Instrument manual surgical instruments. Technologies, Llc Orthopedic Manual Surgical LXH Valeo CP Instruments; Valeo PS Instruments; 888.4540 Amedica Corporation Instrument Valo VBR Instruments Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Arthrex California, Inc. Instrument Orthopedic Manual Surgical LXH Probe,driver,mallet,scissors. 888.4540 Arthrex Manufacturing Instrument Orthopedic Manual Surgical LXH Various. 888.4540 Arthrex, Inc. Instrument Orthopedic Manual Surgical LXH Orthopedic resurfacing instrument. 888.4540 Arthrosurface, Inc. Instrument Orthopedic Manual Surgical LXH Carpal tunnel blade. 888.4540 Ascent Healthcare Solutions Instrument Orthopedic Manual Surgical LXH Rongeurs, forceps, drill guide, plate holder, 888.4540 Atlas Spine Inc. Instrument screw drivers,. Orthopedic Manual Surgical LXH Orthopedic manual surgical instruments. 888.4540 Beere Precision Medical Instrument Instruments, Kmedic, Telef Orthopedic Manual Surgical LXH Various types of orthopedic manual surgical 888.4540 Beznoska S.R.O. Instrument instruments Orthopedic Manual Surgical LXH Various types of manual instruments. 888.4540 Biomet Microfixation Inc. Instrument Orthopedic Manual Surgical LXH A full line of instrumentation and delivery 888.4540 Biomet Sports Medicine, Inc Instrument systems for arthroscopic surgery. Orthopedic Manual Surgical LXH Various instruments, cement gun inserter 888.4540 Biomet, Inc. Instrument applicators, templates, gage sets. Orthopedic Manual Surgical LXH COMPRESSOR-DISTRACTOR 888.4540 Blackstone Medical, Inc. Instrument Orthopedic Manual Surgical LXH 888.4540 Bolt Bethel, Llc Instrument Orthopedic Manual Surgical LXH Various. 888.4540 Bonutti Research, Inc. Instrument

Source: MDRWeb.com 101 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Orthopedic Manual Surgical LXH 888.4540 Brasseler Usa - Komet Instrument Medical Orthopedic Manual Surgical LXH 888.4540 Centinel Spine Inc. Instrument Orthopedic Manual Surgical LXH Various 888.4540 Christian Diener Gmbh. & Instrument Co. K.G. Orthopedic Manual Surgical LXH Alignment guide, cutting blocks/guides, 888.4540 Conformis, Inc. Instrument drill. Orthopedic Manual Surgical LXH 888.4540 ConMed Linvatec Instrument Orthopedic Manual Surgical LXH CTS 888.4540 Core Essence Orthopaedics Instrument Inc. Orthopedic Manual Surgical LXH Raylor insturments and accessories. 888.4540 Covidien Lp, Formerly Instrument Registered As United States Surgical Orthopedic Manual Surgical LXH 888.4540 De Good Dimensional Instrument Concepts, Inc. Orthopedic Manual Surgical LXH Various 888.4540 Depuy Ace S.A.’R.L. Instrument Orthopedic Manual Surgical LXH Various 888.4540 Depuy France S.A. Instrument Orthopedic Manual Surgical LXH Various types of manual orthopedic surgical 888.4540 Depuy Mitek, A Johnson & Instrument instruments. Johnson Company Orthopedic Manual Surgical LXH Various types of manual surgical orthopedic 888.4540 Depuy Orthopaedics, Inc. Instrument instruments. Orthopedic Manual Surgical LXH Various types of orthopedic instruments 888.4540 Depuy Spine, Inc. Instrument (depth gauge, retractor). Orthopedic Manual Surgical LXH Various types of manual surgical orthopedic 888.4540 Depuy-Raynham, A Div. Of Instrument instruments. Depuy Orthopaedics Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Derron Surgical Instruments, Instrument Inc. Orthopedic Manual Surgical LXH VertecoR Cement Staging Osteotome 888.4540 DFine Inc. Instrument Orthopedic Manual Surgical LXH Various 888.4540 Diwymed Production Gmbh Instrument Orthopedic Manual Surgical LXH 888.4540 DJO Inc. Instrument Orthopedic Manual Surgical LXH Various types of orthopedic manual surgical 888.4540 Eurocut, Ltd. Instrument instrument Orthopedic Manual Surgical LXH Disassembly instruments use 888.4540 Friedrich Daniels Gmbh Instrument Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Gauthier Biomedical, Inc. Instrument Orthopedic Manual Surgical LXH Various types of orthopedic hand 888.4540 Hermann Mueller Instrument instruments Orthopedic Manual Surgical LXH Ortopedic manual surgical instrument. 888.4540 Hiatt Metal Products Instrument Orthopedic Manual Surgical LXH 888.4540 Holmed Corporation Instrument Orthopedic Manual Surgical LXH Various 888.4540 Howmedica International S. Instrument De R.L., Orthopedic Manual Surgical LXH Distractor/compressor/screwdriver/bender/ 888.4540 In’Tech Medical, Instrument probe/forcep. Incorporated Orthopedic Manual Surgical LXH Retrosector 888.4540 Intrinsic Therapeutics Inc. Instrument Orthopedic Manual Surgical LXH Various types and sizes of ortho. man. surg. 888.4540 Invuity, Inc. Instrument instruments. Orthopedic Manual Surgical LXH 888.4540 Invuity, Inc. Instrument Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Jb Medical Development Instrument Inc.

Source: MDRWeb.com 102 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Orthopedic Manual Surgical LXH Various orthopedic manual surgical 888.4540 K2m, Inc. Instrument instrumnets. Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument 888.4540 Koscher & Wurtz Gmbh Instrument Orthopedic Manual Surgical LXH Stainless-streel pliers, needle nose, wire 888.4540 Mark Medical Instrument cutters, wire twisters, and pin cutters. Manufacturing, Inc. Orthopedic Manual Surgical LXH Quick-connect pin chucks. 888.4540 Medcon Llc Instrument Orthopedic Manual Surgical LXH Various hip retractors. 888.4540 Medical Device Concepts, Instrument Llc. Orthopedic Manual Surgical LXH Orthopedic manual surgical instruments. 888.4540 Medical Innovators, Inc. Instrument Orthopedic Manual Surgical LXH Various orthopedic manual surgical 888.4540 Medisiss Instrument instruments,sterile. Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Medtronic Puerto Rico Instrument Operations Co.,Med Rel Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Medtronic Sofamor Danek Instrument Instrument Manufacturing Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Medtronic Sofamor Danek Instrument Usa, Inc. Orthopedic Manual Surgical LXH Curette. 888.4540 Medtronic Spine Llc Instrument Orthopedic Manual Surgical LXH Multiple and various. 888.4540 Millstone Medical Instrument Outsourcing Orthopedic Manual Surgical LXH 888.4540 minSURG International, Inc. Instrument Orthopedic Manual Surgical LXH Allofix cortical bone pin insertion kit. 888.4540 Musculoskeletal Transplant Instrument Foundation Orthopedic Manual Surgical LXH NEMCOMED ORTHOPEDIC 888.4540 Nemcomed Instrument Orthopedic Manual Surgical LXH Orthopedic manual surgical instruments. 888.4540 Nuvasive, Inc. Instrument Orthopedic Manual Surgical LXH Various types of orthopedic instruments. 888.4540 Omni Life Science, Inc Instrument Orthopedic Manual Surgical LXH 888.4540 Opi, Inc. Instrument Orthopedic Manual Surgical LXH Distraction instrument 888.4540 Orthofix Srl Instrument Orthopedic Manual Surgical LXH Instruments. 888.4540 Orthohelix Surgical Designs, Instrument Inc. Orthopedic Manual Surgical LXH Funnel. 888.4540 Orthovita, Inc. Instrument Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Paradigm Biodevices, Inc. Instrument Orthopedic Manual Surgical LXH Various types of orthopedic components. 888.4540 Performance Machine Instrument Technologies Orthopedic Manual Surgical LXH Various manual surgical instruments. 888.4540 Platinum Surgical Instruments, Instrument Inc. Orthopedic Manual Surgical LXH 888.4540 Precimed Instrument Orthopedic Manual Surgical LXH 888.4540 Precision Medical Instrument Technologies Orthopedic Manual Surgical LXH Various orthopedic manual surgical 888.4540 Rkl Technologies, Inc. Instrument instruments. Orthopedic Manual Surgical LXH Prosthesis pusher and guide. 888.4540 Salumedica, L.L.C. Instrument Orthopedic Manual Surgical LXH 888.4540 Shukla Medical Instrument Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Small Bone Innovations, Inc. Instrument Orthopedic Manual Surgical LXH Various 888.4540 Smith & Nephew Instrument Orthopaedics, Gmbh

Source: MDRWeb.com 103 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Orthopedic Manual Surgical LXH Orthopedic manual surgical instruments. 888.4540 Spinal Elements, Inc. Instrument Orthopedic Manual Surgical LXH Orthopedics manual surgical instruments. 888.4540 Spinal Kinetics, Inc. Instrument Orthopedic Manual Surgical LXH Spinal intervertebral body sizers. 888.4540 Spine Smith Partners L.P. Instrument Orthopedic Manual Surgical LXH Various types of distractors. 888.4540 Spine Wave, Inc. Instrument Orthopedic Manual Surgical LXH 888.4540 Spineworks Medical Inc. Instrument Orthopedic Manual Surgical LXH Knife blade. 888.4540 Sterilmed, Inc. Instrument Orthopedic Manual Surgical LXH 888.4540 Stryker Endoscopy Instrument Orthopedic Manual Surgical LXH Various types of sterile, disposable brushes 888.4540 Stryker Instruments, Instrument and cement sculps. Instruments Div. Orthopedic Manual Surgical LXH Various types of sterile, disposable brushes 888.4540 Stryker Puerto Rico, Ltd. Instrument and cement sculps. Orthopedic Manual Surgical LXH Various 888.4540 Stryker Trauma Ag (Sa) Instrument Orthopedic Manual Surgical LXH Shield. 888.4540 Surgical Implant Generation Instrument Network (Sign) Orthopedic Manual Surgical LXH Various types of manual instruments. 888.4540 Symmetry Medical Usa, Inc Instrument Orthopedic Manual Surgical LXH Hip instruments, knee instruments, 888.4540 Symmetry Medical Usa, Inc. Instrument orthopedic instruments. Orthopedic Manual Surgical LXH MULTIPLE 888.4540 Symmetry Medical, Inc. Instrument Orthopedic Manual Surgical LXH Pedicle screw system 888.4540 Synthes San Diego Instrument accessories,instruments. Orthopedic Manual Surgical LXH 888.4540 T & L Sharpening, Inc. Instrument Orthopedic Manual Surgical LXH 888.4540 Tissue Banks International Instrument Orthopedic Manual Surgical LXH Various. 888.4540 Tmj Solution, Inc Instrument Orthopedic Manual Surgical LXH 888.4540 Trinity Orthopedics, Llc Instrument Orthopedic Manual Surgical LXH Raylor instruments and accessories. 888.4540 Ussc Puerto Rico, Inc. Instrument Orthopedic Manual Surgical LXH Various orthopedic manual surgical 888.4540 Von Zabern Surgical Instrument instruments. Orthopedic Manual Surgical LXH 888.4540 V--Operations Management Instrument Consulting, Orthopedic Manual Surgical LXH Gore smoother crucial tool. 888.4540 W.L. Gore & Associates,Inc Instrument Orthopedic Manual Surgical LXH Orthopedic manual surgical instrument. 888.4540 Warsaw Orthopedic, Inc. Instrument Orthopedic Manual Surgical LXH Drill guide,screwdriver,drill,bone tamp. 888.4540 West Coast Surgical Llc. Instrument Orthopedic Manual Surgical LXH Various laparoscopic spinal fusion 888.4540 Zimmer Spine, Inc. Instrument instruments. Orthopedic Manual Surgical LXH Acetabular trial shell. 888.4540 Zimmer Trabecular Metal Instrument Technology Bone Mill LYS Manual bone mill. 888.4540 Biomedical Composites, Ltd. Bone Mill LYS Bio comp mini mill. 888.4540 Biomet Microfixation Inc. Bone Mill LYS Various types of bone mills. 888.4540 Depuy Orthopaedics, Inc. Bone Mill LYS Bone crusher, all types. 888.4540 H & H Co. Bone Mill LYS Analytical mills designed to reduce dry, 888.4540 Ika-Works, Inc. hard and brittle materials including bone and teeth for analytical evaluation.

Source: MDRWeb.com 104 Implant Class I Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Bone Mill LYS Bone mill. 888.4540 Lenox-Maclaren Surgical Corp. Bone Mill LYS 888.4540 Lighthouse Industries Bone Mill LYS Tessier bone mill. 888.4540 Striker Corp. Bone Mill LYS Orthopedic manual surgical instrument. 888.4540 Symmetry Medical Usa, Inc. Bone Mill LYS Bone mill. 888.4540 Tracer Designs, Inc. Accessories, Arthroscopic NBH Scope,dilator,c-mount adaptor,arthroscopy 888.1100 Arthrex Manufacturing sheath. Accessories, Arthroscopic NBH Obturators, sheaths. 888.1100 Arthrex, Inc. Accessories, Arthroscopic NBH Orthopedic cannulas and trocars. 888.1100 Ascent Healthcare Solutions Accessories, Arthroscopic NBH Accessories,arthroscope. 888.1100 ConMed Linvatec Endoscopy Accessories, Arthroscopic NBH Orthopedic arthroscopic accessories, 888.1100 Medisiss sterile. Accessories, Arthroscopic NBH Arthroscope. 888.1100 Medtronic Sofamor Danek Instrument Manufacturing Accessories, Arthroscopic NBH Arthroscope. 888.1100 Medtronic Sofamor Danek Usa, Inc. Accessories, Arthroscopic NBH Surgical instruments. 888.1100 Nuvasive, Inc. Accessories, Arthroscopic NBH OsseoFlex 1.0 Steerable Needle 888.1100 Osseon Therapeutics, Inc. Accessories, Arthroscopic NBH Rigid telescope. 888.1100 Sohniks Endoscopy, Inc. Accessories, Arthroscopic NBH Various types of cannulas. 888.1100 Spine Wave, Inc. Accessories, Arthroscopic NBH Obturators, sheaths. 888.1100 Sterilmed, Inc. Accessories, Arthroscopic NBH Various arthroscopic accessories. 888.1100 Synthes San Diego Accessories, Arthroscopic NBH Arthroscope. 888.1100 Warsaw Orthopedic, Inc. Button, Iris, Eye, Artificial NCK 886.3200 Danz Inc. Button, Iris, Eye, Artificial NCK Artificial eye. 886.3200 Erickson Labs Northwest Button, Iris, Eye, Artificial NCK Practice eye for laser’s (Argon, Yag) 886.3200 Eyetech Ltd. procedures demostration Button, Iris, Eye, Artificial NCK Corneal button or iris button. 886.3200 Ocular Concepts Llc. Button, Iris, Eye, Artificial NCK Eye, artificial, plastic, custom made. 886.3200 Randal Minor Ocular Prosthetics Inc. Button, Iris, Eye, Artificial NCK Artificial eye. 886.3200 Texas Eye Prosthetics Llc Injector, Vertebroplasty (does Not OAR OsseoFlex 1.0 Steerable Needle 888.4200 Osseon Therapeutics, Inc. Contain Cement) Injector, Vertebroplasty (does Not OAR On-Control 888.4200 Vidacare Corp. Contain Cement) Spinal Channeling Instrument, OCJ Benvenue VCF Osteo Coil System 888.4540 Benvenue Medical, Inc. Vertebroplasty Spinal Channeling Instrument, OCJ 888.4540 Spineworks Medical Inc. Vertebroplasty

Implant Class I Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Connector, Shunt FJQ 876.5540 Apothecary Products, Inc. Connector, Shunt FJQ 876.5540 Lifemed Of California Connector, Shunt FJQ CSF (cerebral spinal fluid) shunt parts. 876.5540 Microcision Llc Instrument, Shunt System Implantation GYK 882.4545 Codman & Shurtleff, Inc Instrument, Shunt System Implantation GYK Various styles of instruments. 882.4545 Integra Neurosciences Pr Instrument, Shunt System Implantation GYK Instruments for shunt system implantation 882.4545 Medos S.A. Instrument, Shunt System Implantation GYK Catheter passer instruments. 882.4545 Medtronic Neurosurgery Instrument, Shunt System Implantation GYK 882.4545 Microcision Llc

Source: MDRWeb.com 105 Implant Class II Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter, Retention, Barium Enema FGD Custom silicone balloon catheters. 876.5980 Manufacturing & Research, With Bag Inc.(Dba Mri Medical) System, Evacuator, Fluid FHF Suction/aspiration system 876.4370 (Ems Sa) Electro Medical Systems System, Evacuator, Fluid FHF 876.4370 Boston Scientific Corporation Catheter and Tip, Suction JOL 880.6740 American Catheter Corp. Catheter and Tip, Suction JOL Various sizes of sterile suction tubes. 880.6740 Anspach Effort Inc. Catheter and Tip, Suction JOL Oral suction catheter. 880.6740 Ballard Medical Products Catheter and Tip, Suction JOL Various 880.6740 Baur Und Haselbarth-Chirurg Gmbh Catheter and Tip, Suction JOL 880.6740 Bausch & Lomb Surgical Catheter and Tip, Suction JOL Sterlie Saline for Device Care; Sterlie Water 880.6740 Baxter Healthcare For Device Care Corporation, Medication Delivery Catheter and Tip, Suction JOL Bulk assembled. 880.6740 Benlan Inc. Catheter and Tip, Suction JOL Catheter and tip, suction (rigid). 880.6740 Biomet Microfixation Inc. Catheter and Tip, Suction JOL SUCTION TUBE 880.6740 Blackstone Medical, Inc. Catheter and Tip, Suction JOL Multiple 880.6740 Catalent Pharma Solutions Catheter and Tip, Suction JOL Trocar Catheter 880.6740 Covidien Catheter and Tip, Suction JOL Suction irrigation system. 880.6740 Covidien Lp, Formerly Registered As United States Surgical Catheter and Tip, Suction JOL 880.6740 Dma Med-Chem Corporation Catheter and Tip, Suction JOL Suction tip. 880.6740 E.A. Beck & Co. Catheter and Tip, Suction JOL Suction. 880.6740 Engineered Medical Solutions Co. Llc. Catheter and Tip, Suction JOL Poole suction tips 880.6740 Erchinger Medizintecnik Catheter and Tip, Suction JOL Hve tips. 880.6740 Hygo Plastic, Inc. Catheter and Tip, Suction JOL Attachment to electrocautery pencil to 880.6740 Implantech Associates, Inc. evaluate smake and aspirate fluids. Catheter and Tip, Suction JOL Various types 880.6740 Kelsar, S.A. Catheter and Tip, Suction JOL Yankaur suction handle. 880.6740 Kentron Health Care, Inc. Catheter and Tip, Suction JOL Suction catheter with control (Disposable u 880.6740 Maersk Medical Pty. Ltd. nit). Catheter and Tip, Suction JOL Suction device. 880.6740 Medical Depot Catheter and Tip, Suction JOL 880.6740 Medline Industries, Inc. Catheter and Tip, Suction JOL Suction catheters. 880.6740 Medline Manufacturing And Services Llc Catheter and Tip, Suction JOL Various types of tip, suction, rigid 880.6740 Michele Cannova Chirurgische Instrumente Catheter and Tip, Suction JOL Various types of tonsillar suction tips 880.6740 Nagashima Medical Instruments Co., Ltd. Catheter and Tip, Suction JOL CATHETER SUCTION TIP 880.6740 O&M Enterprise Catheter and Tip, Suction JOL 880.6740 Pmt Corp. Catheter and Tip, Suction JOL Sterile water, sterile saline. 880.6740 Primary Care Solutions, Inc. Catheter and Tip, Suction JOL 880.6740 Sage Products, Inc. Catheter and Tip, Suction JOL Irrigation tips. 880.6740 Stryker Puerto Rico, Ltd. Catheter and Tip, Suction JOL Suction assembly. 880.6740 Terumo Cardiovascular Systems (Tcvs) Catheter and Tip, Suction JOL 880.6740 Trinity Sterile, Inc. Catheter and Tip, Suction JOL 880.6740 Tuzik Boston Catheter and Tip, Suction JOL 880.6740 Vygon Corp. Catheter and Tip, Suction JOL Yankauer suction catheter (sterile) 880.6740 Vygon S A Catheter and Tip, Suction JOL Various. 880.6740 Wel Industries, Inc. Catheter and Tip, Suction JOL 880.6740 Wells Johnson Co.

106 Implant Class II Devices — General Controls — 510(k) Exempt

Product name Product code Product description Regulation number Company name Catheter and Tip, Suction JOL 880.6740 Witte Gmbh Device, External Penile Rigidity LKY Mega vac systems. 876.5020 Barry J. Kaplan, Inc. Device, External Penile Rigidity LKY Battery-operated constriction erection 876.5020 Pos-T-Vac, Inc. device. Device, External Penile Rigidity LKY 876.5020 Repro-Med Systems, Inc. Device, External Penile Rigidity LKY Vt-1. 876.5020 V.T.S.,Inc.

Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Conduction, Anesthetic BSO 868.5120 Arrow International, Inc. Catheter, Conduction, Anesthetic BSO Pleural Anaesthesia Catheter, chest tube to 868.5120 Axiom Medical, Inc. allow administration of anaesthetic for pain management while draining. Various sizes, multipostion entry port. Catheter, Conduction, Anesthetic BSO Catheter securement device, epidural 868.5120 Baxter Productos Medicos, catheters Ltda. Catheter, Conduction, Anesthetic BSO Catheter Adapter; Catheter Introducer 868.5120 Becton Dickinson And Co. Catheter, Conduction, Anesthetic BSO $60.00 for anesthesia catheter. 868.5120 Cardiomed Supplies Inc. Catheter, Conduction, Anesthetic BSO 868.5120 Embo-Optics, Llc. Catheter, Conduction, Anesthetic BSO Stingray Epidural Cath. Connector 868.5120 Epimed International, Inc. Catheter, Conduction, Anesthetic BSO SOAKER CATHETER, designed to infuse drugs 868.5120 I-Flow Corporation into large incisions to relieve postoperative pain; catheter length FDA approved up to 12.5 cm. Catheter, Conduction, Anesthetic BSO 19- to 28-ga epidural with or without 868.5120 Micor, Inc. radiopaque stripe. Also, spinal catheters. Catheter, Conduction, Anesthetic BSO Various. 868.5120 Smiths Medical Asd, Inc. Catheter, Conduction, Anesthetic BSO Various anesthetic conduction catheters. 868.5120 Stryker Instruments, Instruments Div. Catheter, Conduction, Anesthetic BSO Various anesthesia conduction catheters. 868.5120 Stryker Puerto Rico, Ltd. Catheter, Conduction, Anesthetic BSO 868.5120 Symbios Medical Products, Llc Pump, Portable, Aspiration (Manual BTA 878.4780 Allied Healthcare Products, or Powered) Inc. Pump, Portable, Aspiration (Manual BTA Suction pump/aspirator. 878.4780 Ambu A/S or Powered) Pump, Portable, Aspiration (Manual BTA Suction pump/aspirator 878.4780 Ambu Intl. A/S or Powered) Pump, Portable, Aspiration (Manual BTA AMBU PPS compact for pharyngeal and 878.4780 Ambu, Inc. or Powered) tracheal suction. Pump, Portable, Aspiration (Manual BTA Suction pump 878.4780 Atmos Medical Apparatus, or Powered) Ltd. Pump, Portable, Aspiration (Manual BTA Wound vacuum. 878.4780 Blue Sky Medical Group or Powered) Incorporated Pump, Portable, Aspiration (Manual BTA Miniature brushless DC diaphragm air 878.4780 Brailsford & Co., Inc. or Powered) pumps. No RFI filtering necessary. Can be mounted in any position. Pump, Portable, Aspiration (Manual BTA PSI-TEC. 878.4780 Byron Medical or Powered) Pump, Portable, Aspiration (Manual BTA Oilless aspirator model 6260, 6260A, or 6261. 878.4780 Contemporary Products, Inc. or Powered) Heavy-duty aspirator that has adjustable vacuum ranges up to 22 in. of mercury (558 mm). Pump, Portable, Aspiration (Manual BTA 878.4780 Covidien Lp or Powered)

107 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pump, Portable, Aspiration (Manual BTA Irrigation pump. 878.4780 Covidien Lp, Formerly or Powered) Registered As United States Surgical Pump, Portable, Aspiration (Manual BTA $788 - $1150 for suction pump for all 878.4780 Encompas Unlimited, Inc. or Powered) endoscopic applications, 2 sizes. Pump, Portable, Aspiration (Manual BTA Aspirator, small or minute volume. 878.4780 Fibra-Sonics, A Division Of or Powered) Misonix, Inc. Pump, Portable, Aspiration (Manual BTA Aspirator. 878.4780 Gardner Denver Thomas Inc. or Powered) Pump, Portable, Aspiration (Manual BTA 878.4780 George Tiemann & Co. or Powered) Pump, Portable, Aspiration (Manual BTA Portable aspiration pump for paracentesis. 878.4780 Gi Supply or Powered) Pump, Portable, Aspiration (Manual BTA Aspiration pump/portable suction unit. 878.4780 Health Care Logistics, Inc. or Powered) Pump, Portable, Aspiration (Manual BTA 878.4780 Impact Instrumentation, Inc. or Powered) Pump, Portable, Aspiration (Manual BTA Flow and vacuum control modes. Low 878.4780 Industrial & Medical Design, or Powered) aspiration rate in stand-by automatically Inc. increases in presence of liquid and switches back to low rate when liquid extracted. No manual control during surgical procedure required. Pump, Portable, Aspiration (Manual BTA Portable suction pump with sterile + non- 878.4780 Innovative Therapies, Inc. or Powered) sterile dressings. Pump, Portable, Aspiration (Manual BTA 878.4780 Jedmed Instruments Co. or Powered) Pump, Portable, Aspiration (Manual BTA Aspirator. 878.4780 Medco Mfg. or Powered) Pump, Portable, Aspiration (Manual BTA 878.4780 Ohio Medical Corp. or Powered) Pump, Portable, Aspiration (Manual BTA Suction pumps with collection 878.4780 Pentax Medical Company or Powered) bottles. Suction pump accessories include cannisters, cannister lids, disposable bags, and cannister accessories. Call for quote. Pump, Portable, Aspiration (Manual BTA 878.4780 Precision Medical, Inc. or Powered) Pump, Portable, Aspiration (Manual BTA Peristalic infiltration/suction pump 878.4780 Servizi Medico Estetici Italinai or Powered) Srl. Pump, Portable, Aspiration (Manual BTA Various. 878.4780 Tennessee Medical or Powered) Equipment, Inc. Pump, Portable, Aspiration (Manual BTA 878.4780 Thomas Products Division or Powered) Pump, Portable, Aspiration (Manual BTA Aspiration pump. 878.4780 Ussc Puerto Rico, Inc. or Powered) Pump, Portable, Aspiration (Manual BTA AC/DC powered irrigation and aspiration 878.4780 Vital Concepts, Inc. or Powered) pumps for suction and irrigation during surgery. Capable of delivering up to 800Hg. Pump, Portable, Aspiration (Manual BTA No common name listed 878.4780 Wisap Gesellschaft Fur or Powered) Wissenschaftl. App. Bau Mbh Tube, Bronchial (W/Wo Connector) BTS 868.5720 Avalon Laboratories, Inc. Tube, Bronchial (W/Wo Connector) BTS Tube,bronchial (20/connector). 868.5720 Boehm Surgical Instrument Corp. Tube, Bronchial (W/Wo Connector) BTS T-Y tracheobronchial tubes in 3 sizes, 868.5720 E. Benson Hood Laboratories, Y-Tubes in multiple sizes, T-Y tube, bronchial Inc. stents with posts. Y-Tubes with posts with Ultra-smooth. Tube, Bronchial (W/Wo Connector) BTS 868.5720 Richard Wolf Medical Instruments Corp. Apparatus, Autotransfusion CAC ATRIUM 2050 and 3650 blood-recovery 868.5830 Atrium Medical Corp. systems. Disposable autotransfusion systems also available. Apparatus, Autotransfusion CAC Postoperative and intraoperative 868.5830 Boehringer Laboratories, Inc. autotransfusion systems.

Source: MDRWeb.com 108 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Apparatus, Autotransfusion CAC APPARATUS, COBE 2991 868.5830 Caridianbct Inc. Apparatus, Autotransfusion CAC Autotransfusion unit accessory for use with 868.5830 ConMed Corporation PLEURA-GARD chest drainage unit. Apparatus, Autotransfusion CAC Disposable autotransfusion systems. 868.5830 Covidien Lp Apparatus, Autotransfusion CAC 868.5830 Covidien Lp, Formerly Registered As Kendall Apparatus, Autotransfusion CAC Transfusion apparatus. 868.5830 Cytori Therapeutics, Inc. Apparatus, Autotransfusion CAC Purchase direct from manufacturer 868.5830 Cytosol Laboratories, Inc. anticoagulant. Citrate dextrose-A, U.S.P. or anticoagulant citrate phosphate dextrose, v.s.p. Apparatus, Autotransfusion CAC Post-operative autotransfusion system. 868.5830 Davol Inc., Sub. C.R. Bard, Inc. Apparatus, Autotransfusion CAC Various 868.5830 Dideco S.P.A. Apparatus, Autotransfusion CAC ORTHOPAT Autotransfusion System 868.5830 Haemonetics Corp. Autotransfusion Apparatus salvages blood during and after orthopedic surgery. Apparatus, Autotransfusion CAC Autotransfusion system. 868.5830 Harvest Technologies, Corp. Apparatus, Autotransfusion CAC Receptal a.t.s. mediastinal liner. 868.5830 Icu Medical (Ut), Inc Apparatus, Autotransfusion CAC Pleural drainage/autotransfusion system. 868.5830 Jostra Bentley, Inc. Apparatus, Autotransfusion CAC Autotransfusion. 868.5830 Medtronic Blood Management Apparatus, Autotransfusion CAC 868.5830 Medtronic Perfusion Systems Apparatus, Autotransfusion CAC BRAT autologous blood transfusion unit. 868.5830 Sorin Group Usa Apparatus, Autotransfusion CAC Various. 868.5830 Stryker Instruments, Instruments Div. Apparatus, Autotransfusion CAC Various. 868.5830 Stryker Puerto Rico, Ltd. Apparatus, Autotransfusion CAC Blood recovery device. 868.5830 Terumo Cardiovascular Systems (Tcvs) Apparatus, Autotransfusion CAC Blood cell separator disposable bowl. 868.5830 The Tech Group Tempe Apparatus, Autotransfusion CAC Autotransfusion chest drainage units and 868.5830 Tyco Healthcare Ireland accessories Limited Apparatus, Autotransfusion CAC Disposable autotransfusion systems. 868.5830 Zimmer Holdings, Inc. Apparatus, Autotransfusion CAC HEMOVAC; Autotransfusion system. 868.5830 Zimmer Orthopaedic Surgical Products Valve, Non-Rebreathing CBP 868.5870 Aerodyne Controls, Inc., A Circor International Company Valve, Non-Rebreathing CBP E valve. 868.5870 Ambu A/S Valve, Non-Rebreathing CBP E valve 868.5870 Ambu Intl. A/S Valve, Non-Rebreathing CBP One way valve, non-rebreathing. 868.5870 Cft, Inc./Life Mask Valve, Non-Rebreathing CBP Transport circuit. 868.5870 Corpak Medsystems, Inc. Valve, Non-Rebreathing CBP Guedel and Berman airways. 868.5870 Eastmed Enterprises, Inc. Valve, Non-Rebreathing CBP Rudolph respiratory valves and masks. 868.5870 Hans Rudolph, Inc. Valve, Non-Rebreathing CBP Non-rebreathing T. 868.5870 Instrumentation Industries, Inc. Valve, Non-Rebreathing CBP One-way exhalation valve that directs 868.5870 Intersurgical Inc. breathing flow to the patient and vents exhaled gases into the atmosphere. Valve, Non-Rebreathing CBP One-way valve on LIFE CPR Masks and 868.5870 Life Corporation Shields. Valve, Non-Rebreathing CBP RespAide - CPR assistance mask and valve 868.5870 Nano Mask Inc. Valve, Non-Rebreathing CBP 868.5870 Passy-Muir Inc. Valve, Non-Rebreathing CBP Exhaled air pulmonary resuscitator 868.5870 Plasco, Inc. Valve, Non-Rebreathing CBP CPR valve used with resuscitation mask for 868.5870 Rondex Products, Inc. CPR. Valve, Non-Rebreathing CBP Disposable resuscitation bag valve. 868.5870 Smiths Medical Asd Inc.

Source: MDRWeb.com 109 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Valve, Non-Rebreathing CBP Resuscitation bag refill valve.; 302 OX 868.5870 Spiracle Technology Inhaltor; OX Inhalator; Gaseous Oxygen Supply Valve; HFOC Valve, Non-Rebreathing CBP PTP rebreathing air valve with oxygen mask. 868.5870 Tagg Industries L.L.C. Valve, Non-Rebreathing CBP 868.5870 U O Equipment Co. Valve, Non-Rebreathing CBP Cpr resuscitator. 868.5870 Work ‘N Leisure Products, Inc. Catheter, Oximeter, Fiberoptic DQE Catheter, oximeter, fiberoptic. 870.1230 Edwards Lifesciences Technology Sarl Catheter, Oximeter, Fiberoptic DQE MULTIPLE 870.1230 Edwards Lifesciences, Llc. Catheter, Oximeter, Fiberoptic DQE $1,050 for fiberoptic catheter oximeter 870.1230 Hospira, Inc. system. Catheter, Oximeter, Fiberoptic DQE Various fiberoptic oximeter catheters. 870.1230 Icu Medical (Ut), Inc Withdrawal/Infusion Pump DQI Saline pump, orthopaedic. 870.1800 Biomet Sports Medicine Withdrawal/Infusion Pump DQI Programmable infusion/withdraw pump. 870.1800 Harvard Apparatus, Inc. Withdrawal/Infusion Pump DQI 870.1800 Karl Storz Endoscopy- America Inc. Withdrawal/Infusion Pump DQI Cardiovascular irrigation pump 870.1800 Storz Endoskop Gmbh Withdrawal/Infusion Pump DQI 870.1800 World Precision Instruments (W.P.I.), Inc. Catheter, Intravascular, Diagnostic DQO Various types of catheters. 870.1200 Abbott Vascular, Cardiac Therapies Catheter, Intravascular, Diagnostic DQO Impella 2.5; MPC and Power Supply; Quick 870.1200 Abiomed, Inc. Set-up Kit Catheter, Intravascular, Diagnostic DQO Sterile diagnostic intravascular catheters. 870.1200 Alpha Medical Instruments Llc Catheter, Intravascular, Diagnostic DQO Various types 870.1200 Angiomed Gmbh & Co. Medizintechnik Kg Catheter, Intravascular, Diagnostic DQO Digital subtraction procedure trays. 870.1200 Argon Medical Devices Inc. Catheter, Intravascular, Diagnostic DQO Angiographic catheter 870.1200 Ashitaka Factory Of Terumo Corporation Catheter, Intravascular, Diagnostic DQO Guide catheter. 870.1200 Biocardia, Inc. Catheter, Intravascular, Diagnostic DQO Infusion catheter. 870.1200 Biosphere Medical, Inc. Catheter, Intravascular, Diagnostic DQO 870.1200 Boston Scientific - Maple Grove Catheter, Intravascular, Diagnostic DQO Microcatueter 870.1200 Boston Scientific Cork Ltd. Catheter, Intravascular, Diagnostic DQO Endovascular snare catheter. 870.1200 Boston Scientific- Neurovascular Catheter, Intravascular, Diagnostic DQO 870.1200 Cardio-Nef, S.A. De C.V. Catheter, Intravascular, Diagnostic DQO Detergent reagent. 870.1200 Clinical Instruments Intl., Inc. Catheter, Intravascular, Diagnostic DQO Diagnostic intravascular catheter. 870.1200 Concentric Medical, Inc. Catheter, Intravascular, Diagnostic DQO Various, disposable waste stations, ultra high 870.1200 Deroyal Surgical - Rose Hill pressure injector lines, sterile. Catheter, Intravascular, Diagnostic DQO Disposable waste station. 870.1200 Deroyal Wound Care Catheter, Intravascular, Diagnostic DQO Atrial pressure monitoring catheter. 870.1200 Edwards Lifesciences Research Medical Catheter, Intravascular, Diagnostic DQO Angiography catheters, various. 870.1200 Edwards Lifesciences Technology Sarl Catheter, Intravascular, Diagnostic DQO 870.1200 Edwards Lifesciences, Llc. Catheter, Intravascular, Diagnostic DQO AngioPAK: Fluorescein angiography kit for 870.1200 Eyesupply Usa, Inc. Ophthalmology Catheter, Intravascular, Diagnostic DQO Angiographic catheters. 870.1200 E-Z-Em, Inc. Catheter, Intravascular, Diagnostic DQO Various sizes of sterile and non-sterile 870.1200 Hakko Medical Co., Ltd. catheter Catheter, Intravascular, Diagnostic DQO 870.1200 Hospira, Inc. Catheter, Intravascular, Diagnostic DQO Electrophysiology (diagnostic/mapping) 870.1200 Irvine Biomedical, Inc. catheter. Catheter, Intravascular, Diagnostic DQO Silicone left ventricular catheter 870.1200 Kelsar, S.A.

Source: MDRWeb.com 110 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Intravascular, Diagnostic DQO C7 Dragonfly; ImageWire 1.5, 1.8 870.1200 LightLab Imaging Inc. Catheter, Intravascular, Diagnostic DQO Silicone carotid shunt catheter, carotid 870.1200 Lucas Medical, Inc. catheter, carotid shunt. Catheter, Intravascular, Diagnostic DQO Angiographic diagnostic catheter 870.1200 Medtronic Vascular Catheter, Intravascular, Diagnostic DQO Performa, Softouch, Impress 870.1200 Merit Medical Systems, Inc. Catheter, Intravascular, Diagnostic DQO Various catheters. 870.1200 Merit Medical Systems, Inc. Catheter, Intravascular, Diagnostic DQO Catheter. 870.1200 Micrus Endovascular Corporation Catheter, Intravascular, Diagnostic DQO 870.1200 Millar Instruments, Inc. Catheter, Intravascular, Diagnostic DQO Various types of angiographic accessories, 870.1200 Navilyst Medical closed systems/kits.; MULTIPLE Catheter, Intravascular, Diagnostic DQO Sterile, infusion catheter. 870.1200 Neuro Vasx, Inc. Catheter, Intravascular, Diagnostic DQO Septostomy catheter and angiographic 870.1200 Numed, Inc. catheter. Catheter, Intravascular, Diagnostic DQO Diagnostic ultrasound transducer catheter. 870.1200 Siemens Medical Solutions Usa, Inc. Ultrasound Division Catheter, Intravascular, Diagnostic DQO NextStep Antegrade Catheter for Chronic 870.1200 Teleflex Medical Hemodialysis Catheter, Intravascular, Diagnostic DQO Infusion catheter, sterile. 870.1200 Therox, Inc. Catheter, Intravascular, Diagnostic DQO Catheters for Temporary Pacing, 870.1200 Vascomed-Institut Fur Electrophysiology, Internal Cardíoversion Kathetertechnologie Gmbh and Ablation. Lead Extraction System. Pacing Wires. Transseptal Needle and Guiding Catheters. Catheter, Intravascular, Diagnostic DQO Catheter, intravascular, diagnostic. 870.1200 Vital Signs Mn, Inc. Catheter, Intravascular, Diagnostic DQO Cardiovascular catheter. 870.1200 Vitalcor, Inc. Catheter, Intravascular, Diagnostic DQO Ultrasound imaging catheter. 870.1200 Volcano Corporation Cannula, Catheter DQR 870.1300 Angiodynamics, Inc. Cannula, Catheter DQR Translumbar aortography needle catheter. 870.1300 Argon Medical Devices Inc. Cannula, Catheter DQR 870.1300 Cadence Science Inc. Cannula, Catheter DQR Transseptal cannula. 870.1300 Cardiac Assist, Inc. Cannula, Catheter DQR Same 870.1300 Combined Instruments (Pvt.), Ltd. Cannula, Catheter DQR Custom design and manufacturing of 870.1300 Diablo Sales & Marketing, catheters and specialty guidewires. Guiding Inc. catheters; stent delivery and drug delivery systems. Cannula, Catheter DQR Various models of cannulas catheter 870.1300 Dimeda Instrumente Gmbh Cannula, Catheter DQR Cannula. 870.1300 Edwards Lifesciences Research Medical Cannula, Catheter DQR 870.1300 Edwards Lifesciences, Llc. Cannula, Catheter DQR Guide and angiography catheters. 870.1300 Insitu Technologies, Inc. Cannula, Catheter DQR Ground cannulae 870.1300 Ispg, Inc. Cannula, Catheter DQR 870.1300 Medovations, Inc. Cannula, Catheter DQR VC2. 870.1300 Medtronic, Inc. Cannula, Catheter DQR 870.1300 Rose Technologies Company Cannula, Catheter DQR 870.1300 Sorin Group Usa Cannula, Catheter DQR Disposable angulated guide sleeve. 870.1300 United States Endoscopy 2.5 mm cannula with angled tip; pass Group cholangiocatheter through the angulated guide sleeve and direct the flexible catheter into the cystic duct. Cannula, Catheter DQR Cardiovascular cannula. 870.1300 Vitalcor, Inc. Occluder, Catheter Tip DQT Catheter tips, disposable 870.1370 Codan Medical Aps Occluder, Catheter Tip DQT 870.1370 Cook Inc. Wire, Guide, Catheter DQX Cardiovascular guidewire. 870.1330 Abbott Vascular, Cardiac Therapies

Source: MDRWeb.com 111 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Wire, Guide, Catheter DQX Guide wire. 870.1330 Abbott Vascular, Vascular Solutions Wire, Guide, Catheter DQX 870.1330 Accellent Inc. Wire, Guide, Catheter DQX .014 through .080, length 20 cm through 400 870.1330 Acme-Monaco Corp. cm, J radius 1.5 mm to 15 mm. Wire, Guide, Catheter DQX VariSoft Guide Wire Extension; VariSoft 870.1330 Advanced Biomedical Steerable Guide Wire Devices, Inc. (Abd, Inc.) Wire, Guide, Catheter DQX 0.038 in. O.D. by 70cm J/straight double 870.1330 Angiodynamics, Inc. ended guidewire. Wire, Guide, Catheter DQX Sniper guide wire. 870.1330 Argon Medical Devices Inc. Wire, Guide, Catheter DQX Various types and sizes of wire guides 870.1330 Arrow Internacional De Mexico, S.A. De C.V. Wire, Guide, Catheter DQX TRUE TORQUE vascular access guidewires. 870.1330 Arrow International, Inc. Wire, Guide, Catheter DQX Guide wire 870.1330 Ashitaka Factory Of Terumo Corporation Wire, Guide, Catheter DQX Guide wire. 870.1330 Avantec Vascular Corp. Wire, Guide, Catheter DQX GUIDEWIRES; TORQUE DEVICE; GUIDEWIRE 870.1330 B. Braun Medical, Inc. TRAY Wire, Guide, Catheter DQX Various 870.1330 Bard Reynosa S.A. De C.V. Wire, Guide, Catheter DQX 870.1330 Becton Dickinson Infusion Therapy Systems, Inc. Wire, Guide, Catheter DQX Guidewire. 870.1330 Biosphere Medical, Inc. Wire, Guide, Catheter DQX Various models of Catheter accessories 870.1330 Biotronik, Inc. Wire, Guide, Catheter DQX 870.1330 Boston Scientific - Maple Grove Wire, Guide, Catheter DQX Guidewires for angiography and 870.1330 Boston Scientific Corp. angioplasty procedures. Wire, Guide, Catheter DQX 870.1330 Boston Scientific Corporation Wire, Guide, Catheter DQX One-way flow control used durning high 870.1330 Boston Scientific Ireland, Ltd. pressure contrast injections Wire, Guide, Catheter DQX Entera; Stingray Guidewire; Stingray 870.1330 BridgePoint Medical Guidewire - Stiff Wire, Guide, Catheter DQX 870.1330 C. R. Bard, Inc., Bard Urological Div. Wire, Guide, Catheter DQX BOURASSA guidewires for cath lab. 870.1330 Cardiomed Supplies Inc. Wire, Guide, Catheter DQX 870.1330 Cardio-Nef, S.A. De C.V. Wire, Guide, Catheter DQX Catheter guidewire. 870.1330 Concentric Medical, Inc. Wire, Guide, Catheter DQX 870.1330 Conceptus, Inc. Wire, Guide, Catheter DQX 870.1330 Cook Inc. Wire, Guide, Catheter DQX 870.1330 Cook Urological, Inc. Wire, Guide, Catheter DQX LIBERATOR Locking System - Universal 870.1330 Cook Vascular, Incorporated locking stylet used during the removal of transvenous cardiac leads. Packaged individually. Wire, Guide, Catheter DQX Guide wire. 870.1330 Cordis Neurovascular, Inc. Wire, Guide, Catheter DQX Catheter guide wire. 870.1330 Datascope Corp., Cardiac Assist Division Wire, Guide, Catheter DQX Guidewires. 870.1330 Ev3 Inc. Wire, Guide, Catheter DQX Guidewire. 870.1330 Ev3 Neurovascular Wire, Guide, Catheter DQX Guidewire. 870.1330 Flowcardia, Inc. Wire, Guide, Catheter DQX Various grades, properties and shapes of 870.1330 Fort Wayne Metals Research precision wire. Prod. Corp. Wire, Guide, Catheter DQX Sterile and non-sterile guidewire. 870.1330 Galt Medical Corp. Wire, Guide, Catheter DQX 870.1330 Guidewire Technologies, Inc. Wire, Guide, Catheter DQX Guidewire. 870.1330 Intella Interventional Systems, Inc.

Source: MDRWeb.com 112 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Wire, Guide, Catheter DQX Various models of guide wires. 870.1330 Interventional Technologies, Inc. Wire, Guide, Catheter DQX Safe-Cross Crossing Wire. A guide wire 870.1330 Intraluminal Therapeutics, designed to cross total occlusions with Inc. Optical Coherance Reflectometetry and Radio Frequency. Wire, Guide, Catheter DQX Various. 870.1330 Maquet Puerto Rico Inc. Wire, Guide, Catheter DQX NEOSOFT Drainage Catheters, 870.1330 Medical Device nephrostomy, biliary, and abscess Technologies, Inc. (Md Tech) drainage. SKATER Drainage Catheters, nephrostomy, biliary, and abscess drainage. TCD Drainage Catheters, nephrostomy, biliary, and abscess drainage. Wire, Guide, Catheter DQX Guide wire, filter wire 870.1330 Medtronic Vascular Wire, Guide, Catheter DQX Diagnostic guidewires. Hydrophilic 870.1330 Merit Medical Systems, Inc. guidewires Wire, Guide, Catheter DQX Guidewire. 870.1330 Merit Medical Systems, Inc. Wire, Guide, Catheter DQX Holder, guide, catheter 870.1330 Michele Cannova Chirurgische Instrumente Wire, Guide, Catheter DQX Wire,guide,catheter. 870.1330 Micrus Endovascular Corporation Wire, Guide, Catheter DQX Various sterile angiographic guidewires and 870.1330 Navilyst Medical accessories. Wire, Guide, Catheter DQX Access guidewire. 870.1330 Neo Metrics, Inc. Wire, Guide, Catheter DQX Aquatrack 870.1330 Nitinol Devices & Components, Inc. Wire, Guide, Catheter DQX Radius 018 Cougar Wire; Radius Cougar 870.1330 Radius Medical Technologies, Wire Inc. Wire, Guide, Catheter DQX LumenVu 870.1330 Sonosite, Inc. Wire, Guide, Catheter DQX Cardiodrive Catheter Advancement Sy 870.1330 Stereotaxis, Inc. Wire, Guide, Catheter DQX 870.1330 Tfx Medical Oem Wire, Guide, Catheter DQX TORAYGUIDE used in percutaneous 870.1330 Toray International America procedures to introduce and position Inc. catheters and other interventional devices in the central and peripheral vasculature. Wire, Guide, Catheter DQX Guide wire. 870.1330 Vnus Medical Technologies, Inc. Wire, Guide, Catheter DQX Doppler guide wire. 870.1330 Volcano Corporation Wire, Guide, Catheter DQX 870.1330 Wytech Industries, Inc. Catheter, Percutaneous DQY Percutaneous catheter. 870.1250 Abbott Vascular, Cardiac Therapies Catheter, Percutaneous DQY Retriever device, catheter. 870.1250 Abbott Vascular, Vascular Solutions Catheter, Percutaneous DQY Percutaneous catheter. 870.1250 Acumen Medical, Inc. Catheter, Percutaneous DQY ANGIOSCULPT SCORIN 870.1250 Angioscore, Inc. Catheter, Percutaneous DQY Sniper guide wire. 870.1250 Argon Medical Devices Inc. Catheter, Percutaneous DQY Pericardiocentesis tray. 870.1250 Ascent Healthcare Solutions Catheter, Percutaneous DQY Wildcat 870.1250 Avinger Inc. Catheter, Percutaneous DQY 870.1250 Boston Scientific - Maple Grove Catheter, Percutaneous DQY Sterling. 870.1250 Boston Scientific - Marina Bay Customer Fulfillment Center Catheter, Percutaneous DQY .; Guider XF 5F Guiding Catheter; Guider XF 870.1250 Boston Scientific Corp. 6F Guiding Catheters; Guider XF 7F Guiding Catheters; Guider XF 8F Guiding Catheters; Guider XF 9F Guiding Catheters; ACUITY Breakaway Guide Catheters Catheter, Percutaneous DQY 870.1250 Brevet, Inc. Catheter, Percutaneous DQY Stingray Catheter; CrossBoss 870.1250 BridgePoint Medical Catheter, Percutaneous DQY 870.1250 Candela Corp.

Source: MDRWeb.com 113 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Percutaneous DQY Various. 870.1250 Cardima, Inc. Catheter, Percutaneous DQY Percutaneous catheter. 870.1250 Concentric Medical, Inc. Catheter, Percutaneous DQY Various types of sterile percutaneous 870.1250 Cordis Neurovascular, Inc. catheter. Catheter, Percutaneous DQY Peripherally inserted central catheters and 870.1250 Covidien Lp, Formerly trays. Registered As Kendall Catheter, Percutaneous DQY Introducer kit. 870.1250 Edwards Lifesciences Technology Sarl Catheter, Percutaneous DQY 870.1250 Edwards Lifesciences, Llc. Catheter, Percutaneous DQY Dual Lumen Catheter 870.1250 Endologix, Inc. Catheter, Percutaneous DQY Catheter, percutaneous. 870.1250 Ev3 Inc. Catheter, Percutaneous DQY High frequency mechanical chronic total 870.1250 Flowcardia, Inc. occlusion recanalization system. Catheter, Percutaneous DQY 870.1250 Hospithera S.A. Catheter, Percutaneous DQY 870.1250 Invatec Catheter, Percutaneous DQY Various types of sterile percutaneous 870.1250 Lumend, Inc. catheters. Catheter, Percutaneous DQY 870.1250 Medical Murray Inc. Catheter, Percutaneous DQY Percutaneous catheter. 870.1250 Medtronic Ep Systems Catheter, Percutaneous DQY Pioneer. 870.1250 Medtronic Vascular Catheter, Percutaneous DQY Attain 870.1250 Medtronic, Inc. Catheter, Percutaneous DQY Guiding catheters. 870.1250 Micrus Design Technology, Inc. Catheter, Percutaneous DQY 870.1250 Millar Instruments, Inc. Catheter, Percutaneous DQY Sterile peripherally inserted central catheter 870.1250 Neo Medical Inc. (picc) tray and accessories. Catheter, Percutaneous DQY 870.1250 Numed Canada, Inc. Catheter, Percutaneous DQY Percutaneous transluminal angioplasty 870.1250 Numed, Inc. catheter. Catheter, Percutaneous DQY Balloon guide catheter. 870.1250 Penumbra, Inc. Catheter, Percutaneous DQY VENTRA percutaneous intravenous 870.1250 Smiths Medical Asd, Inc. catheters. The one-piece radiopaque silicone catheters are available in single, dual and triple lumen configurations. Catheter, Percutaneous DQY Pta balloon catheter. 870.1250 Spectrascience, Inc. Catheter, Percutaneous DQY Proxis Flow Control System; Proxis System 870.1250 St. Jude Medical Atrial Fibrillation Catheter, Percutaneous DQY Percutaneous introducer kit. 870.1250 Thomas Medical Products, Inc. Catheter, Percutaneous DQY Glider 870.1250 TriReme Medical Inc. Catheter, Percutaneous DQY GP, TRU-FLO drainage catheters. 870.1250 Uresil, Llc Catheter, Percutaneous DQY Tunneler. 870.1250 Ussc Puerto Rico, Inc. Catheter, Percutaneous DQY Balloon catheter. 870.1250 W.L. Gore & Associates,Inc Catheter, Steerable DRA Steerable catheter systems. 870.1280 Boston Scientific Corporation Catheter, Steerable DRA 870.1280 Catheter Research, Inc. (Cri) Catheter, Steerable DRA Custom design and manufacturing of 870.1280 Diablo Sales & Marketing, catheters and specialty guidewires. Guiding Inc. catheters; stent delivery and drug delivery systems. Catheter, Steerable DRA 870.1280 Greatbach Medical Catheter, Steerable DRA Steerable guide catheter. 870.1280 Hansen Medical, Inc. Catheter, Steerable DRA Straight and angled support catheters for a 870.1280 Intraluminal Therapeutics, variety of clinical applications. Inc. Catheter, Steerable DRA Various models of steerable catheters. 870.1280 Maquet Puerto Rico Inc. Catheter, Steerable DRA RF Ablation Catheter 870.1280 Oscor, Inc. Stylet, Catheter DRB 870.1380 Accellent Inc.

Source: MDRWeb.com 114 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Stylet, Catheter DRB Catheter wire stylets. 870.1380 Acme-Monaco Corp. Stylet, Catheter DRB Custom design and manufacturing of 870.1380 Diablo Sales & Marketing, catheters and specialty guidewires. Guiding Inc. catheters; stent delivery and drug delivery systems. Stylet, Catheter DRB Various grades, properties and shapes of 870.1380 Fort Wayne Metals Research precision wire. Prod. Corp. Stylet, Catheter DRB Various models of stylets. 870.1380 Maquet Puerto Rico Inc. Stylet, Catheter DRB 870.1380 Ranfac Corp. Stylet, Catheter DRB 870.1380 Sanderson-Macleod, Inc. Stylet, Catheter DRB Catheter stylet. 870.1380 St. Jude Medical Atrial Fibrillation (Endocardial Solutions) Stylet, Catheter DRB 870.1380 Unimed S.A. Stylet, Catheter DRB 870.1380 Vygon Corp. Stylet, Catheter DRB 870.1380 Witte Gmbh Stylet, Catheter DRB 870.1380 Wytech Industries, Inc. Catheter, Electrode Recording, Or DRF Sterile electrophysiology catheters. 870.1220 Alpha Medical Instruments Probe, Electrode Recording Llc Catheter, Electrode Recording, Or DRF Various types of sterile electrophysiology 870.1220 Arrow International, Inc. Probe, Electrode Recording catheters & accessories. Catheter, Electrode Recording, Or DRF Various. 870.1220 Biosense Webster Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Cardiac mapping system 870.1220 Biosense Webster (Israel), Ltd. Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Diagnostic electrophysiology catheters. 870.1220 Biosense Webster, Inc Probe, Electrode Recording Catheter, Electrode Recording, Or DRF 870.1220 Boston Scientific Corporation Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Various. 870.1220 Cardima, Inc. Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Electrophysiology mapping catheter & 870.1220 Catheffects, Llc. Probe, Electrode Recording cable. Catheter, Electrode Recording, Or DRF Various. 870.1220 Ep Technologies, Inc. Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Oxygen electrode 870.1220 Gesellschaft Fur Medizinische Probe, Electrode Recording Sondentechnik Gms, M Catheter, Electrode Recording, Or DRF Cardiac electrophysiology catheters. 870.1220 Medtronic Ep Systems Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Cardiac electrophysiology catheters. 870.1220 Medtronic Puerto Rico Probe, Electrode Recording Operations Co., Villalba Catheter, Electrode Recording, Or DRF EPR-800 Ultra-Miniature Catheter for 870.1220 Millar Instruments, Inc. Probe, Electrode Recording Electrophysiology Research -- Animal Use Only Catheter, Electrode Recording, Or DRF Temporary ballon pacing probe. 870.1220 Numed, Inc. Probe, Electrode Recording Catheter, Electrode Recording, Or DRF Sterile electrophysiology catheter and 870.1220 Prorhythm, Inc. Probe, Electrode Recording connection cable. Catheter, Electrode Recording, Or DRF 870.1220 St. Jude Medical Atrial Probe, Electrode Recording Fibrillation Catheter, Electrode Recording, Or DRF Electrode catheter/electrophysiology 870.1220 Vascomed Institut Fur Probe, Electrode Recording catheter Kathetertechnologie Gmbh Pacemaker, Cardiac, External DRO Pacemaker, cardiac, external 870.5550 Ballard Medical Products Transcutaneous (Non-Invasive) transcutaneous (non-invasive). Pacemaker, Cardiac, External DRO Defibrillation electrodes, gradient edge. 870.5550 Covidien Lp, Formerly Transcutaneous (Non-Invasive) Registered As Tyco Healthcare Pacemaker, Cardiac, External DRO External pacemaker. 870.5550 Heartbeat Medical Corp. Transcutaneous (Non-Invasive) Pacemaker, Cardiac, External DRO Various external cardiac monitors. 870.5550 Invivo Corporation Transcutaneous (Non-Invasive)

Source: MDRWeb.com 115 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pacemaker, Cardiac, External DRO MULTIPLE 870.5550 Philips Medical Systems Transcutaneous (Non-Invasive) Pacemaker, Cardiac, External DRO LIFEPAK 9P, 10: defibrillator/monitor/ 870.5550 Physio-Control, Inc. Transcutaneous (Non-Invasive) pacemaker. LIFEPAK 11 defibrillator/ pacemaker (mates to LIFEPAK 11 diagnostic cardiac monitor) Pacemaker, Cardiac, External DRO Defib/cardiovert/pace/monitoring 870.5550 Tz Medical Inc. Transcutaneous (Non-Invasive) electrode. Pacemaker, Cardiac, External DRO 870.5550 Welch Allyn Protocol, Inc. Transcutaneous (Non-Invasive) Pacemaker, Cardiac, External DRO ZOLL R Series 870.5550 Zoll Medical Corp. Transcutaneous (Non-Invasive) Prosthesis, Vascular Graft, Of 6mm DSY ARTEGRAFT. All collagen vascular grafts, 870.3450 Artegraft, Inc. And Greater Diameter available in 6, 7, and 8mm outside diameters and lengths up to 52cm. Prosthesis, Vascular Graft, Of 6mm DSY ATRIUM ADVANTA PTFE vascular grafts 870.3450 Atrium Medical Corp. And Greater Diameter available in a wide range of sizes and configurations. Prosthesis, Vascular Graft, Of 6mm DSY Regular, thin wall, straight or tapered 870.3450 Bard Peripheral Vascular, Inc. And Greater Diameter IMPRA-FLEX grafts (PTFE). VASCUTEK knitted and woven Dacron grafts. Prosthesis, Vascular Graft, Of 6mm DSY Fabrics,grafts,pledgets. 870.3450 Bard Shannon Limited And Greater Diameter Prosthesis, Vascular Graft, Of 6mm DSY In clinical trials in U.S., Commercialized in 870.3450 Corvita Corp. And Greater Diameter Europe, & Japan. Prosthesis, Vascular Graft, Of 6mm DSY Storage and preservation (liquid nitrogen) 870.3450 Cryolife, Inc. And Greater Diameter of human vascular graft tissue. Shipment of grafts for implant within 24 hrs. Prosthesis, Vascular Graft, Of 6mm DSY PTFE vascular graft. 870.3450 Edwards Lifesciences, Llc. And Greater Diameter Prosthesis, Vascular Graft, Of 6mm DSY 870.3450 Endovascular Instruments, And Greater Diameter Inc. Prosthesis, Vascular Graft, Of 6mm DSY HEMASHIELD 870.3450 Maquet Cardiovascular LLC And Greater Diameter Prosthesis, Vascular Graft, Of 6mm DSY 870.3450 Thoratec Corporation And Greater Diameter Prosthesis, Vascular Graft, Of 6mm DSY 870.3450 Tuzik Boston And Greater Diameter Prosthesis, Vascular Graft, Of 6mm DSY Vascular graft. 870.3450 W.L. Gore & Associates,Inc And Greater Diameter Tester, Pacemaker Electrode DTA EXPMT 900 tests all functions of any external 870.3720 Netech, Corp. Function pacemaker. EXPMT 2000 with larger display and added features provides quick comprehensive testing of all external pacemakers. Analyzer, Pacemaker Generator DTC 870.3630 Apc Medical Ltd. Function Analyzer, Pacemaker Generator DTC Same. 870.3630 Biotek Instruments, Inc. Function Analyzer, Pacemaker Generator DTC SCE 22. 870.3630 Ela Medical, Inc. Function Analyzer, Pacemaker Generator DTC CARDIOBEEPER ECG transmitter. 870.3630 Meridian Medical Function Technologies Analyzer, Pacemaker Generator DTC Pacemaker system analyzer. 870.3630 Oscor, Inc. Function Analyzer, Pacemaker Generator DTC Pacing system analyzer, dual chamber 870.3630 Pace Medical, Inc. Function modes AOO, AAI, VOO, VVI, DOO, DVI, DDD. Pacemaker Lead Adapter DTD 870.3620 Alto Development Corp. Pacemaker Lead Adapter DTD 870.3620 Ela Medical, Inc. Pacemaker Lead Adapter DTD 870.3620 Greatbach Medical Pacemaker Lead Adapter DTD Various models of lead adapters. 870.3620 Maquet Puerto Rico Inc. Pacemaker Lead Adapter DTD Lead adaptors. Permanent pacing leads. 870.3620 Oscor, Inc.

Source: MDRWeb.com 116 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pacemaker Lead Adapter DTD Subclavian cardiac pacing lead introducer 870.3620 St. Jude Medical Cardiac sets available in single pack, single sheath/ Rhythm Management Div. dilator 8-13Fr; single pack, dual sheath/ dilator 8-10Fr. and 10 pack dispenser box 8 -13Fr. Pacemaker Lead Adapter DTD Permanent pacing lead adaptor 870.3620 Vascomed Institut Fur Kathetertechnologie Gmbh Control, Pump Speed, DWA Various 870.4380 Em-Tec Gmbh Cardiopulmonary Bypass Control, Pump Speed, DWA Tandem Heart Escort Controller, Levitronix 870.4380 Minnetronix Inc. Cardiopulmonary Bypass Centrimag Primary Consol Control, Pump Speed, DWA 870.4380 Terumo Cardiovascular Cardiopulmonary Bypass Systems, Corp Pump, Blood, Cardiopulmonary DWB BIOPLUS. 870.4370 Medtronic, Inc. Bypass, Roller Type Pump, Blood, Cardiopulmonary DWB 870.4370 Sorin Group Usa Bypass, Roller Type Pump, Blood, Cardiopulmonary DWB 870.4370 Terumo Cardiovascular Bypass, Roller Type Systems, Corp Tubing, Pump, Cardiopulmonary DWE CORD CARE device to facilitate placement 870.4390 Cardiomed Supplies Inc. Bypass of endotracheal tube Tubing, Pump, Cardiopulmonary DWE No common name listed 870.4390 Haemotronic, S.P.A. Bypass Advanced Medical Technologies Tubing, Pump, Cardiopulmonary DWE Surgical grade tubing. 870.4390 Jostra Bentley, Inc. Bypass Tubing, Pump, Cardiopulmonary DWE Tubing. 870.4390 Medtronic Blood Bypass Management Tubing, Pump, Cardiopulmonary DWE 870.4390 Medtronic Perfusion Systems Bypass Tubing, Pump, Cardiopulmonary DWE 870.4390 Novosci Corp. Bypass Tubing, Pump, Cardiopulmonary DWE 870.4390 Sorin Group Usa Bypass Tubing, Pump, Cardiopulmonary DWE Pump tubing. 870.4390 Terumo Cardiovascular Bypass Systems (Tcvs) Tubing, Pump, Cardiopulmonary DWE Pump tubing. 870.4390 Terumo Cardiovascular Bypass Systems (Tcvs) Tubing, Pump, Cardiopulmonary DWE 870.4390 Terumo Cardiovascular Bypass Systems, Corp Catheter, Cannula and Tubing, DWF Vein graft vessel cannula. 870.4210 Alliant Healthcare Products Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Various types of shunts, nerve pads, 870.4210 Atek Medical Vascular, Cardiopulmonary Bypass cardioplegia, and aspirating needles. Catheter, Cannula and Tubing, DWF Carotid bypass shunt,shunts. 870.4210 Bard Shannon Limited Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Cardiovascular catheter, cannula and 870.4210 California Medical Vascular, Cardiopulmonary Bypass tubing; vascular cardiopulmonary bypass. Laboratories, Inc. Catheter, Cannula and Tubing, DWF Various. 870.4210 Cardeon Corp. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Cardioplegia cannula. 870.4210 Cascade Life Solutions, Llc Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Various models of perfusion cannula, vessel 870.4210 Chase Medical, Lp Vascular, Cardiopulmonary Bypass shunt, vent valve, vessel cannula. Catheter, Cannula and Tubing, DWF The “better-venter”. 870.4210 Circulatory Technology, Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Carotid bypass shunt. 870.4210 Clinical Instruments Intl., Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF 870.4210 Cook Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF 870.4210 Covidien Lp Vascular, Cardiopulmonary Bypass

Source: MDRWeb.com 117 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Cannula and Tubing, DWF Parallel y connector,perfusion adapter,vena 870.4210 Covidien Lp, Formerly Vascular, Cardiopulmonary Bypass caval catheter,artery shunts,various. Registered As Kendall Catheter, Cannula and Tubing, DWF Carotid bypass shunt. 870.4210 Covidien Lp, Formerly Vascular, Cardiopulmonary Bypass Registered As United States Surgical Catheter, Cannula and Tubing, DWF Cardiac insulation pad 870.4210 Dmc Medical Ltd. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Various sizes & types of sterile catheters & 870.4210 Edwards Lifesciences Vascular, Cardiopulmonary Bypass cannulae. Research Medical Catheter, Cannula and Tubing, DWF 870.4210 Edwards Lifesciences, Llc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Cannula. 870.4210 Estech, Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF CANNULA AND TUBING 870.4210 Fresenius Medical Care North Vascular, Cardiopulmonary Bypass America Catheter, Cannula and Tubing, DWF Various cardiopulmonary bypass vascular 870.4210 Integra Neurosciences Pr Vascular, Cardiopulmonary Bypass catheter. Catheter, Cannula and Tubing, DWF Cardiopulmonary bypass catheters, 870.4210 Jostra Bentley, Inc. Vascular, Cardiopulmonary Bypass cannula and tubing. Catheter, Cannula and Tubing, DWF Parallel “y” connector, perfusion adaptor, 870.4210 Kelsar, S.A. Vascular, Cardiopulmonary Bypass vena caval catheter artey shunts, per Catheter, Cannula and Tubing, DWF Catheter, cannula and tubing. 870.4210 Medtronic Blood Vascular, Cardiopulmonary Bypass Management Catheter, Cannula and Tubing, DWF 870.4210 Medtronic Dlp Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF ORIGEN perfusion catheters. 870.4210 Origen Biomedical, Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF 870.4210 Pemco, Inc. - Medical Div. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Aortic perfusion cannula and tubing. 870.4210 Shelhigh, Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF 870.4210 Smiths Medical Asd, Inc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Left vent safety valve. 870.4210 Surge Medical Solutions, Llc. Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Circuit tubing. 870.4210 Terumo Cardiovascular Vascular, Cardiopulmonary Bypass Systems (Tcvs) Catheter, Cannula and Tubing, DWF Catheters, cannulas, tubing, and 870.4210 Terumo Cardiovascular Vascular, Cardiopulmonary Bypass accessories. Systems (Tcvs) Catheter, Cannula and Tubing, DWF 870.4210 Terumo Cardiovascular Vascular, Cardiopulmonary Bypass Systems, Corp Catheter, Cannula and Tubing, DWF Various types of thoracic, venous, and vena 870.4210 Vitalcor, Inc. Vascular, Cardiopulmonary Bypass cava catheters. Catheter, Cannula and Tubing, DWF Coronary cannula. 870.4210 Voss Medical Products Vascular, Cardiopulmonary Bypass Catheter, Cannula and Tubing, DWF Catheters, seldinger technique (sterile) - 870.4210 Vygon S A Vascular, Cardiopulmonary Bypass tubing Apparatus, Suction, Patient Care DWM 870.0505 Allied Healthcare Products, Inc. Catheter, Embolectomy DXE SYNTEL catheters complete line of regular 870.5150 Applied Medical Resource and spring tipped latex-free balloon Corporation catheters (2F-7F) packaged in tube packs. Catheter, Embolectomy DXE Multiple 870.5150 Arrow Internacional De Mexico, S.A. De C.V. Catheter, Embolectomy DXE Embolectomy catheters featuring a 870.5150 Biosensors International - Usa complete line of springed tipped and standard latex balloon catheters (2F-7F) in convenient tube packs. Catheter, Embolectomy DXE Embolectomy catheter 870.5150 Biosensors Intl. Pte. Ltd. Catheter, Embolectomy DXE Thrombectomy catheter system 870.5150 Boston Scientific Ireland, Ltd. Catheter, Embolectomy DXE Carotid bypass shunt. 870.5150 Clinical Instruments Intl., Inc.

Source: MDRWeb.com 118 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Embolectomy DXE VASCU-FLO silicone embolectomy balloon 870.5150 Covidien Lp catheter. Catheter, Embolectomy DXE Embolectomy catheter. 870.5150 Edwards Lifesciences Technology Sarl Catheter, Embolectomy DXE Fogarty Thru-Lumen Embolectomy Cath 870.5150 Edwards Lifesciences, Llc. Catheter, Embolectomy DXE Embolectomy catheter. 870.5150 Genesis Medical Interventional, Inc. Catheter, Embolectomy DXE Keeper Embolectomy Catheter; IQ Cath 870.5150 Hotspur Technologies Inc. PTA Balloon Catheter Catheter, Embolectomy DXE Various. 870.5150 Lucas Medical, Inc. Catheter, Embolectomy DXE Catheter, embolectomy. 870.5150 Lumen Biomedical, Inc. Catheter, Embolectomy DXE Custom silicone balloon catheters. 870.5150 Manufacturing & Research, Inc.(Dba Mri Medical) Catheter, Embolectomy DXE Aspiration catheter. 870.5150 Medtronic Vascular Catheter, Embolectomy DXE Same. 870.5150 Omnisonics Medical Technologies Catheter, Embolectomy DXE Embolectomy catheter. 870.5150 Radius Medical Technologies, Inc. Catheter, Embolectomy DXE Pronto LP Extraction Catheter 870.5150 Vascular Solutions, Inc. Catheter, Septostomy DXF 870.5175 Cook Inc. Catheter, Septostomy DXF Atrioseptostomy catheter. 870.5175 Edwards Lifesciences Technology Sarl Catheter, Septostomy DXF 870.5175 Edwards Lifesciences, Llc. Catheter, Septostomy DXF 870.5175 Medtronic Vascular Catheter, Septostomy DXF 870.5175 Numed, Inc. Transducer, Pressure, Catheter Tip DXO 870.2870 Edwards Lifesciences, Llc. Transducer, Pressure, Catheter Tip DXO Doppler vascular access device. 870.2870 Escalon Trek Medical Transducer, Pressure, Catheter Tip DXO 870.2870 Medical Measurements, Inc. Transducer, Pressure, Catheter Tip DXO Direct measurement of physiological 870.2870 Millar Instruments, Inc. pressures (sizes 2F-8F). Also with fluid-velocity sensor. Transducer, Pressure, Catheter Tip DXO Pressure guide wire. 870.2870 Volcano Corporation Injector and Syringe, Angiographic DXT Angiographic injection system. 870.1650 Acist Medical Systems, Inc. Injector and Syringe, Angiographic DXT Angiographic injector syringe. 870.1650 Argon Medical Devices Inc. Injector and Syringe, Angiographic DXT Inflation devices QL 1006, QL 1455, QL 870.1650 Atrion Medical Products, Inc. QL1030, QL2015, QL 2540, and QL 6015. Fluid delivery, injection and pressure delivery devices. Injector and Syringe, Angiographic DXT 870.1650 C. R. Bard, Inc., Bard Urological Div. Injector and Syringe, Angiographic DXT High Pressure Flex ConnectingTubing 870.1650 Covidien Injector and Syringe, Angiographic DXT Various control syringes, sterile and non- 870.1650 Deroyal Surgical - Rose Hill sterile. Injector and Syringe, Angiographic DXT Control syringes. 870.1650 Deroyal Wound Care Injector and Syringe, Angiographic DXT Various types angiographic syringes. 870.1650 Icu Medical (Ut), Inc Injector and Syringe, Angiographic DXT Optistar mr injector. 870.1650 Mallinckrodt Inc., Liebel- Flarsheim Business Injector and Syringe, Angiographic DXT 870.1650 Marconi Medical Systems, Deutschland Gmbh Injector and Syringe, Angiographic DXT Angiography injector - Medrad Mark V 870.1650 Medrad, Inc. ProVis injection system. Injector and Syringe, Angiographic DXT Various types of angiographic syringe 870.1650 Navilyst Medical accessories and contrast injection lines. Injector and Syringe, Angiographic DXT Contrast injector syringe, parts and 870.1650 Nemoto Medical U.S., Inc. accessories. System, Catheter Control, Steerable DXX Steerable catheter control system. 870.1290 Hansen Medical, Inc. System, Catheter Control, Steerable DXX Steerable catheter control system. 870.1290 Intraluminal Therapeutics, Inc.

Source: MDRWeb.com 119 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name System, Catheter Control, Steerable DXX Various models of catheter control systems. 870.1290 Stereotaxis, Inc. Patch, Pledget And Intracardiac, DXZ Fabrics,grafts,pledgets. 870.3470 Bard Shannon Limited PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Cardiovascular patch. 870.3470 Bridger Biomed, Inc. PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Cardiovascular patch kit (sterile). 870.3470 Chase Medical, Lp PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ CorMatrix ECM for Pericardial Closure; 870.3470 CorMatrix Cardiovascular PETP, PTFE, Polypropylene CorMatrix ECM for Cardiac Tissue Repair Inc. Patch, Pledget And Intracardiac, DXZ Ptfe pledget. 870.3470 Covidien Lp, Formerly PETP, PTFE, Polypropylene Registered As United States Surgical Patch, Pledget And Intracardiac, DXZ CryoPatch SG Pulm. Human Cardia 870.3470 Cryolife, Inc. PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Various, cardiovascular patch. 870.3470 Deroyal Surgical - Rose Hill PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Sterile teflon pledgets. 870.3470 Ethicon, Llc. PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ HEMASHIELD 870.3470 Maquet Cardiovascular LLC PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Intracardiac patch or pledget. 870.3470 Mast Biosurgery Usa Inc. PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Patch. 870.3470 Shelhigh, Inc. PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ CorRestore(TM) System; Bovine pericardial 870.3470 Somanetics Corp. PETP, PTFE, Polypropylene patch system uniquely designed for cardiac repair and reconstruction and especially well-suited for Surgical Ventricular Restoration (SVR). Patch, Pledget And Intracardiac, DXZ Peri-Guard Cardiovascular Patch; Supple 870.3470 Synovis Life Technologies, Inc PETP, PTFE, Polypropylene Peri-Guard; Vascu-Guard Patch, Pledget And Intracardiac, DXZ 870.3470 Tuzik Boston PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Teflon pledget 870.3470 Tyco Healthcare Uk Ltd. PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Cardiovascular patch. 870.3470 W.L. Gore & Associates,Inc PETP, PTFE, Polypropylene Patch, Pledget And Intracardiac, DXZ Patch “sterile”. 870.3470 Yama, Inc. PETP, PTFE, Polypropylene Introducer, Catheter DYB Various sizes sterile catheter introducer and 870.1340 Abbott Vascular Inc. dilators for percutaneous use. Introducer, Catheter DYB Sterile rotating hemostatic valve or external 870.1340 Abbott Vascular, Cardiac plastic valve. Therapies Introducer, Catheter DYB The Wand MicroAccess Safety Introducer 870.1340 Access Scientific Inc. Introducer, Catheter DYB Introducing catheter. 870.1340 Acumen Medical, Inc. Introducer, Catheter DYB Sterile introducer sets. 870.1340 Alpha Medical Instruments Llc Introducer, Catheter DYB 870.1340 Angiodynamics, Inc. Introducer, Catheter DYB Percutaneous introducer kits, sizes from 6 to 870.1340 Angiodynamics, Inc. 16 french. Introducer, Catheter DYB Innervasc access system. 870.1340 Argon Medical Devices Inc. Introducer, Catheter DYB Various 870.1340 Arrow Internacional De Mexico, S.A. De C.V. Introducer, Catheter DYB Percutaneous sheath introducer. 870.1340 Arrow International, Inc. Introducer, Catheter DYB Various. 870.1340 Arrow International, Inc. Introducer, Catheter DYB Various 870.1340 As Advanced Medical Systems Introducer, Catheter DYB Catheter introducer 870.1340 Ashitaka Factory Of Terumo Corporation Introducer, Catheter DYB Femoral cannula and introducer. 870.1340 Atek Medical

Source: MDRWeb.com 120 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Introducer, Catheter DYB Intradyne 870.1340 B. Braun Medical, Inc. Introducer, Catheter DYB 870.1340 B. Braun Oem Division, B. Braun Medical Inc. Introducer, Catheter DYB Various 870.1340 Bard Reynosa S.A. De C.V. Introducer, Catheter DYB 870.1340 Becton Dickinson Infusion Therapy Systems, Inc. Introducer, Catheter DYB ACCUFLEX, sheath introducer. ACCUFLEX 870.1340 Bipore, Inc. Guiding Sheath for Carotids. ACCUFLEX Dialysis Declotting Sheath. Introducer, Catheter DYB ANGIOPORT catheter introducer. 870.1340 Boston Scientific Corp. Introducer, Catheter DYB VALVEKIT Complete range of introducer 870.1340 Cardiomed Supplies Inc. with locking device for introducing balloon catheter. Introducer, Catheter DYB 870.1340 Cardio-Nef, S.A. De C.V. Introducer, Catheter DYB ViperSheath 870.1340 Cardiovascular Systems, Inc. Introducer, Catheter DYB Introducers. 870.1340 Clinical Instruments Intl., Inc. Introducer, Catheter DYB 870.1340 Cook Inc. Introducer, Catheter DYB 870.1340 Covidien Lp Introducer, Catheter DYB Sheath introducer kit. 870.1340 Cryocor, Inc. Introducer, Catheter DYB Catheter introducer set. 870.1340 Datascope Corp., Cardiac Assist Division Introducer, Catheter DYB Custom design and manufacturing of 870.1340 Diablo Sales & Marketing, catheters and specialty guidewires. Guiding Inc. catheters; stent delivery and drug delivery systems. Introducer, Catheter DYB Various 870.1340 Dimeda Instrumente Gmbh Introducer, Catheter DYB 870.1340 Dma Med-Chem Corporation Introducer, Catheter DYB Introducer. 870.1340 Edwards Lifesciences Research Medical Introducer, Catheter DYB Introducer, catheter. 870.1340 Edwards Lifesciences Technology Sarl Introducer, Catheter DYB Intracardiac tontroducing sheath and 870.1340 Ep Technologies, Inc. accessories. Introducer, Catheter DYB Percutaneous with catheter ECC05. 870.1340 Ethicon Endo-Surgery, Inc. Introducer, Catheter DYB Y-connector. 870.1340 Ev3 Inc. Introducer, Catheter DYB FEMCARE suprapubic catheter introducer, 870.1340 Femcare Ltd. Lexan/LDPE trocar and cannula sizes 12ch and 16ch, sterile. Introducer, Catheter DYB Various types of sterile & non-sterile 870.1340 Galt Medical Corp. tearaway introducer sheaths.; Micro-Access Tearaway; Elite HV Introducer, Catheter DYB 870.1340 Greatbach Medical Introducer, Catheter DYB Sure-Grip Flashback 870.1340 Hart Enterprises, Inc. Introducer, Catheter DYB 870.1340 Hospira, Inc. Introducer, Catheter DYB Various. 870.1340 Icu Medical (Ut), Inc Introducer, Catheter DYB Various. 870.1340 Inrad Introducer, Catheter DYB Introducer needle. 870.1340 Integra Lifesciences Corp. Introducer, Catheter DYB 870.1340 Kimura Medical Instrument Co. Ltd. Introducer, Catheter DYB 870.1340 Lifemed Of California Introducer, Catheter DYB For use with intra-aortic balloon catheters. 870.1340 MAQUET Introducer, Catheter DYB 870.1340 Medtronic Vascular Introducer, Catheter DYB SOLO-TRAK. 870.1340 Medtronic, Inc. Introducer, Catheter DYB Blood containment device. Captiva. 870.1340 Merit Medical Systems, Inc. Introducer, Catheter DYB Various types of introducer sheaths and 870.1340 Navilyst Medical accessories and introducer sheath kits.

Source: MDRWeb.com 121 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Introducer, Catheter DYB Introduceer, catheter. 870.1340 Neo Medical Inc. Introducer, Catheter DYB Sheath. 870.1340 Nmt Medical, Inc. Introducer, Catheter DYB Sterile catheter for access during 870.1340 Onset Medical Corporation endovascular procedures. Introducer, Catheter DYB Lead introducer. 870.1340 Oscor, Inc. Introducer, Catheter DYB Transjugular liver access set. 870.1340 Promex Technologies, Llc Introducer, Catheter DYB Majestik angiographic needle incorporates 870.1340 Specialized Health Products a built-in safety device which reduces the International, Inc. risk of accidental needlestick injuries. Introducer, Catheter DYB Percutaneous introducer kits in sizes from 870.1340 St. Jude Medical Atrial 4 to 16 french; introducers with hemostasis Fibrillation valves venous introducers and peel-away introducers.; Maximum; Ultimum; Engage Introducer; Engage TR Introducer Introducer, Catheter DYB Subclavian cardiac pacing lead introducer 870.1340 St. Jude Medical Cardiac sets 8-14Fr. Rhythm Management Div. Introducer, Catheter DYB Introducer needle. 870.1340 Stryker Instruments, Instruments Div. Introducer, Catheter DYB Provides flexibility in strategically positioning 870.1340 Taut, Inc. the cholangiogram catheter. Models PI-63 & PI-93 available. Introducer, Catheter DYB Catheter introducer. 870.1340 Terumo Medical Corporation Introducer, Catheter DYB 870.1340 Tfx Medical Oem Introducer, Catheter DYB Percutaneous sets. 870.1340 Thomas Medical Products, Inc. Introducer, Catheter DYB Various types of sterile percutaneous 870.1340 Thomas Medical Products, introducers. Inc. Introducer, Catheter DYB 870.1340 Thoratec Corporation Introducer, Catheter DYB 870.1340 Vernay Laboratories, Inc. Introducer, Catheter DYB Safety Introducer Needle, OTN & Seldinger 870.1340 Vlv Associates, Inc. Introducer, Catheter DYB Catheter introducer. 870.1340 Vnus Medical Technologies, Inc. Introducer, Catheter DYB 870.1340 Vygon Corp. Introducer, Catheter DYB Percutaneous introducer (sterile) 870.1340 Vygon S A Introducer, Catheter DYB Introducer sheath. 870.1340 W.L. Gore & Associates,Inc Prosthesis, Vascular Graft,of Less DYF Regular, thin wall, straight or tapered 870.3450 Bard Peripheral Vascular, Inc. Than 6mm Diameter IMPRA-FLEX grafts (PTFE). Prosthesis, Vascular Graft,of Less DYF Fabrics,grafts,pledgets. 870.3450 Bard Shannon Limited Than 6mm Diameter Prosthesis, Vascular Graft,of Less DYF In clinical trials in U.S., Europe and Japan. 870.3450 Corvita Corp. Than 6mm Diameter Prosthesis, Vascular Graft,of Less DYF Storage and preservation (liquid nitrogen) 870.3450 Cryolife, Inc. Than 6mm Diameter of human saphenous vein tissue. Shipment of vein for implant within 24 hrs. Prosthesis, Vascular Graft,of Less DYF PTFE vascular graft. 870.3450 Edwards Lifesciences, Llc. Than 6mm Diameter Prosthesis, Vascular Graft,of Less DYF 870.3450 Endovascular Instruments, Than 6mm Diameter Inc. Prosthesis, Vascular Graft,of Less DYF Exxcel 870.3450 Maquet Cardiovascular LLC Than 6mm Diameter Prosthesis, Vascular Graft,of Less DYF 870.3450 Thoratec Corporation Than 6mm Diameter Prosthesis, Vascular Graft,of Less DYF 870.3450 Tuzik Boston Than 6mm Diameter Prosthesis, Vascular Graft,of Less DYF Sterile vascular graft. 870.3450 W.L. Gore & Associates,Inc Than 6mm Diameter Catheter, Flow Directed DYG Sterile diagnostic catheters. 870.1240 Alpha Medical Instruments Llc Catheter, Flow Directed DYG Various catheter kits including protective 870.1240 Argon Medical Devices Inc. sleeves.

Source: MDRWeb.com 122 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Flow Directed DYG Various. 870.1240 Arrow International, Inc. Catheter, Flow Directed DYG 870.1240 B. Braun Medical Catheter, Flow Directed DYG Thermodilution catheters, PA monitoring 870.1240 Biosensors International - Usa catheters, and Paceport catheters with patented SafetyWedge. Catheter, Flow Directed DYG Various 870.1240 Biosensors Intl. Pte. Ltd. Catheter, Flow Directed DYG Introducers. 870.1240 Clinical Instruments Intl., Inc. Catheter, Flow Directed DYG Various. 870.1240 Edwards Lifesciences Technology Sarl Catheter, Flow Directed DYG 870.1240 Edwards Lifesciences, Llc. Catheter, Flow Directed DYG Flow-directed catheter. 870.1240 Hantel Technologies Catheter, Flow Directed DYG 870.1240 Hospira, Inc. Catheter, Flow Directed DYG Various types of flow directed catheter. 870.1240 Icu Medical (Ut), Inc Catheter, Flow Directed DYG Balloon-type cardiovascular catheter. 870.1240 Vitalcor, Inc. Implant, Endosseous, Root-form DZE Dental implant. 872.3640 Altiva Corp. Implant, Endosseous, Root-form DZE Dental implants titanium. 872.3640 Astra Tech Ab Implant, Endosseous, Root-form DZE Various types of sterile and non-sterile 872.3640 Astra Tech Inc custom abutments and accessories. Implant, Endosseous, Root-form DZE ROOT-FORM - MULTIPLE 872.3640 Attachments International, Inc. Implant, Endosseous, Root-form DZE Implant kit & tool kit. 872.3640 Basic Dental Implant Systems, Inc. Implant, Endosseous, Root-form DZE Bicon. 872.3640 Bicon, Llc Implant, Endosseous, Root-form DZE Dental implant. 872.3640 Biohorizons Implant Systems, Inc. Implant, Endosseous, Root-form DZE Various endosseous implants and 872.3640 Biomet 3i abutments including the NanoTite Implant,the NanoTite Tapered Implant and the Certain® PREVAIL® Implant with the Certain® QuickSeat Connection®. Implant, Endosseous, Root-form DZE ORTHODONTIC - ORTHODONTIC 872.3640 Biomet Microfixation Inc. ANCHORAGE SYSTEM Implant, Endosseous, Root-form DZE Dental implant, endosseous, accessories 872.3640 Blue Sky Bio, Llc and instruments. Implant, Endosseous, Root-form DZE Dental implant. 872.3640 Coastal Biocare Implant, Endosseous, Root-form DZE Dental implant. 872.3640 Crystal Medical Technology Implant, Endosseous, Root-form DZE Design and manufacture custom medical 872.3640 Danlin Products, Inc. products. GMP approved. Implant, Endosseous, Root-form DZE 872.3640 Dentsply Prosthetics Implant, Endosseous, Root-form DZE Dental Implants, Copings and Screws 872.3640 Deringer-Ney, Inc. Implant, Endosseous, Root-form DZE Ucla & universal abutments. 872.3640 Diamodent Implant, Endosseous, Root-form DZE Implant system. 872.3640 Dio Usa Implant, Endosseous, Root-form DZE No common name listed 872.3640 Dunlop Medical Products Implant, Endosseous, Root-form DZE Duo-Dent Surgical-Prosthetic Kit. 872.3640 Duo-Dent Dental Implant Systems Llc. Implant, Endosseous, Root-form DZE ROOT-FORM - GC Aadva Implant System; 872.3640 Gc America, Inc. multiple Implant, Endosseous, Root-form DZE 872.3640 Impladent Ltd. Implant, Endosseous, Root-form DZE 872.3640 Implant Center Of The Palm Beaches Implant, Endosseous, Root-form DZE Mini Dental iplant and traditional implants. 872.3640 Imtec, A 3m Company Implant, Endosseous, Root-form DZE Dental implant device. 872.3640 Intra-Lock International Implant, Endosseous, Root-form DZE Orthodontic implant 872.3640 Medi-Dent Aps Implant, Endosseous, Root-form DZE 872.3640 Microcision Llc Implant, Endosseous, Root-form DZE Implant, endosseous 872.3640 Micromeccanica Di Bianchi Lucia

Source: MDRWeb.com 123 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Implant, Endosseous, Root-form DZE Endosseous dental implant, components & 872.3640 Nobel Biocare Usa, Llc accessories. Implant, Endosseous, Root-form DZE Contract manufacturer of dental implant 872.3640 O Company parts. Attachments for endosseous implants also available. Implant, Endosseous, Root-form DZE Dental implant. 872.3640 Oco Inc. Implant, Endosseous, Root-form DZE Implant endosseous. 872.3640 Oratronics, Inc. Implant, Endosseous, Root-form DZE Implant, endosseous, root-form. 872.3640 Ortho Organizers, Inc. Implant, Endosseous, Root-form DZE Ramus frame implant; single tooth implant; 872.3640 Pacific Implant, Inc. ramus blade. Implant, Endosseous, Root-form DZE 872.3640 Park Dental Research Corp./ Implant Center Implant, Endosseous, Root-form DZE Dental implant. 872.3640 Quantum Bioengineering, Ltd. Implant, Endosseous, Root-form DZE Blade implant 872.3640 Ra.Mo S.N.C. Di Rangoni & Co. Implant, Endosseous, Root-form DZE Various. 872.3640 Renew Biocare Corp. Implant, Endosseous, Root-form DZE The complete Cal-form dental line: 872.3640 Renick Ent., Inc. implants, attachments, drills, surgical kits. Implant, Endosseous, Root-form DZE Various prosthetic components 872.3640 Rhein 83 Srl (accessories) Implant, Endosseous, Root-form DZE 872.3640 Schuetz-Dental Gmbh Implant, Endosseous, Root-form DZE Dental abutments & supplies. 872.3640 Speedent Dental Supplies Implant, Endosseous, Root-form DZE IMPLA-MED; External hex titanium screw 872.3640 Sterngold and cylinder forms. ERA Implant Implant, Endosseous, Root-form DZE Various implants,accessories and 872.3640 Straumann Manufacturing, instruments for dental implant system. Inc. Implant, Endosseous, Root-form DZE 872.3640 Titan Implants, Inc. Implant, Endosseous, Root-form DZE ROOT-FORM 872.3640 Universal Implant Systems, Inc. Implant, Endosseous, Root-form DZE IMPAC. Abutments for implants, implant 872.3640 Vident accessories and tools for use with implant manufacturer’s products. Implant, Endosseous, Root-form DZE 872.3640 Zest Anchors, Inc. Implant, Endosseous, Root-form DZE 872.3640 Zimmer Dental, Inc. Denture, Preformed (Partially EKO 872.3600 Alpine Dental Laboratory, Prefabricated Denture) Inc. Denture, Preformed (Partially EKO 872.3600 Artisan Dental Laboratory Prefabricated Denture) Denture, Preformed (Partially EKO Preformed denture kit. 872.3600 Dental Procedures, Inc. L.L.C. Prefabricated Denture) Denture, Preformed (Partially EKO 872.3600 Hennessy Dental Laboratory Prefabricated Denture) Denture, Preformed (Partially EKO 872.3600 Hermanson Dental Prefabricated Denture) Denture, Preformed (Partially EKO Upper/lower/full/partial denture 872.3600 Interdent, Inc. Prefabricated Denture) Denture, Preformed (Partially EKO 872.3600 Ivoclar Vivadent, Inc. Prefabricated Denture) Denture, Preformed (Partially EKO VITAPAN and Physiodens denture teeth, 872.3600 Vident Prefabricated Denture) including Lingoform for lingualized occlusion technique Implant, Subperiosteal ELE 872.3645 Dentsply Prosthetics Implant, Subperiosteal ELE 872.3645 Jardon Eye Prosthetics, Inc. Implant, Subperiosteal ELE 872.3645 Microcision Llc Implant, Subperiosteal ELE Contract manufacturer of dental implant 872.3645 O Company parts. Implant, Subperiosteal ELE Subperiosteal implant. 872.3645 Oco Inc.

Source: MDRWeb.com 124 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Implant, Subperiosteal ELE Implant, subperiosteal. 872.3645 Pentron Laboratory Technologies Denture, Plastic, Teeth ELM Full denture, pl denture, temporary crowns. 872.3590 A Plus Dental Lab Denture, Plastic, Teeth ELM Denture, partial denture. 872.3590 American Dental Center Of Provo Denture, Plastic, Teeth ELM Dentures plastic teeth. 872.3590 American Dental Designs Inc. Denture, Plastic, Teeth ELM JUSTI BLEND. 872.3590 American Tooth Industries Denture, Plastic, Teeth ELM BELODENTE - artificial teeth made with 872.3590 Antonio Ribeiro-Belodente acrylic resin. Produtos Dentarios, Ltda Denture, Plastic, Teeth ELM 872.3590 Candulor Dental Gmbh Denture, Plastic, Teeth ELM Acrylic denture teeth. 872.3590 Choices Technologies Denture, Plastic, Teeth ELM Plastic dentures. 872.3590 D. Sign Dental Lab, Inc. Denture, Plastic, Teeth ELM 872.3590 Dentsply Canada, Ltd. Denture, Plastic, Teeth ELM 872.3590 Dentsply International, Inc. Denture, Plastic, Teeth ELM MYERSON/KENSON Anterior and posterior 872.3590 Dentsply Prosthetics denture teeth. Denture, Plastic, Teeth ELM Crown, bridge and denture. 872.3590 Global Dentech Inc. Denture, Plastic, Teeth ELM 872.3590 Hermanson Dental Denture, Plastic, Teeth ELM Denture. 872.3590 Hong Kong Dental Lab Denture, Plastic, Teeth ELM Plastic teeth 872.3590 Industrias Dentales, Ltda. Denture, Plastic, Teeth ELM Denture teeth 872.3590 Ivoclar A.G. Denture, Plastic, Teeth ELM ANTARIS/POSTARIS, SR VIVODENT PE, 872.3590 Ivoclar Vivadent, Inc. SR ORTHOTYP PE, SR ORTHOPLANE/SR ORTHOLINGUAL, SR ORTHOSIT PE. Denture, Plastic, Teeth ELM Tuff-dent 872.3590 Jamica Tooth Manufacturing Company Ltd. Denture, Plastic, Teeth ELM Denture material. 872.3590 Kerr Corp. Denture, Plastic, Teeth ELM 872.3590 Lafayette Dental Lab., Inc. Denture, Plastic, Teeth ELM 872.3590 Lisadent Corp. Denture, Plastic, Teeth ELM Artificial acrylic teeth 872.3590 Masterdent Ltda. Denture, Plastic, Teeth ELM Acrylic teeth 872.3590 Technodent Industries Denture, Plastic, Teeth ELM Acrylic Teeth. 872.3590 Univac Dental Company Denture, Plastic, Teeth ELM Denture teeth. 872.3590 Valplast Intl. Corp. Denture, Plastic, Teeth ELM 872.3590 Vident Denture, Plastic, Teeth ELM ODIPAL, ODILUX. 872.3590 Weithas, Johannes Polymer, Composite Synthetic PTFE ESF Implantable material for augmenting tissue 878.3500 W.L. Gore & Associates,Inc With Carbon-Fiber, ENT deficiencies. Polymer, ENT Synthetic-PIFE, ESH 874.3620 Bisico Gmbh & Co. Kg Silicon Elastomer, Polyethylene, Polyurethane Polymer, ENT Synthetic-PIFE, ESH Silastic silicone sheeting in various 874.3620 Pillar Surgical, Inc. Silicon Elastomer, Polyethylene, thicknesses, 6 x 8 x desired thickness (0.005 Polyurethane to 0.080 in.). Polymer, ENT Synthetic-PIFE, ESH Silicone tubing. 874.3620 Technical Products, Inc. Silicon Elastomer, Polyethylene, Polyurethane Prosthesis, Esophageal ESW Montgomery esophageal tube (15mm 878.3610 Boston Medical Products, Inc. o.d.), Montgomery salivary bypass tubes om sizes of 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm o.d. Prosthesis, Esophageal ESW 878.3610 Boston Scientific Corp. Prosthesis, Esophageal ESW 878.3610 Boston Scientific Corporation Prosthesis, Esophageal ESW Esophageal stent 878.3610 Boston Scientific Ireland, Ltd. Prosthesis, Esophageal ESW Esophageal prosthesis. 878.3610 Cook Endoscopy Prosthesis, Esophageal ESW Salivary bypass tubes: 8, 10, 12, 14, 16, 18, 878.3610 E. Benson Hood Laboratories, and 20mm O.D., esophageal stent. Inc. Prosthesis, Esophageal ESW Esophageal prosthesis. 878.3610 Ev3 Inc.

Source: MDRWeb.com 125 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Esophageal ESW Esophageal and introducer prosthesis. 878.3610 Wilson-Cook Medical, Inc. Prosthesis, Otoplasty ESY Various types and styles of ear prostheses 878.3590 Nagashima Medical Instruments Co., Ltd. Tube, Shunt, Endolymphatic ESZ Huang/Gibson inner ear shunt. 874.3820 E. Benson Hood Laboratories, Inc. Replacement, Ossicular Prosthesis, ETA Various types of total ossicular replacement 874.3495 Grace Medical, Inc. Total prosthesis-sterile. Replacement, Ossicular Prosthesis, ETA Various types and sizes of total ossicular 874.3495 Gyrus Ent L.L.C., Sub. Of Total replacements. Gyrus Acmi, Inc. Replacement, Ossicular Prosthesis, ETA Middle Ear Prostheses for Tympanoplasty 874.3495 Kurz, Heinz Gmbh Total and Stapedioplasty; Titanium Replacement, Ossicular Prosthesis, ETA POLYCEL prosthesis. 874.3495 Medtronic Xomed, Inc. Total Replacement, Ossicular Prosthesis, ETA 874.3495 Medtronic Xomed, Inc. Total Prosthesis, Partial Ossicular ETB Various 874.3450 Audio Technologies S.R.L. Replacement Prosthesis, Partial Ossicular ETB Various types of partial ossicular 874.3450 Grace Medical, Inc. Replacement replacement prosthesis-sterile. Prosthesis, Partial Ossicular ETB Various types and sizes of partial ossicular 874.3450 Gyrus Ent L.L.C., Sub. Of Replacement replacements. Gyrus Acmi, Inc. Prosthesis, Partial Ossicular ETB 874.3450 Jedmed Instruments Co. Replacement Prosthesis, Partial Ossicular ETB Total and partial ossicular replacement 874.3450 Mednet Locator, Inc. Replacement prostheses. Prosthesis, Partial Ossicular ETB FLEX H/A partials. 874.3450 Medtronic Xomed, Inc. Replacement Prosthesis, Partial Ossicular ETB 874.3450 Medtronic Xomed, Inc. Replacement Prosthesis, Laryngeal (Taub) EWL Soft tissue bulking media. 874.3730 Bioform Medical, Inc. Prosthesis, Laryngeal (Taub) EWL Various types of prosthesis. 874.3730 Biomet Microfixation Inc. Prosthesis, Laryngeal (Taub) EWL Montgomery small, medium, large adult 874.3730 Boston Medical Products, Inc. and child size laryngeal stent. Also, Montgomery laryngeal keel, sizes 12mm, 14mm, and 16mm. Prosthesis, Laryngeal (Taub) EWL Adult male, adult female, adolescent, and 874.3730 E. Benson Hood Laboratories, child size silicone laryngeal stents. Steg Stent Inc. for reconstruction after semi-laryngectomy. Laryngeal keel: 12mm, 14mm and 16mm, eliachar stent and inflatable stent. Prosthesis, Laryngeal (Taub) EWL MULTIPLE 874.3730 Helix Medical, Inc. Catheter, Ureteral, Gastro-Urology EYB Straight and Pigtail Ureteral catheters and 876.5130 Applied Medical Resource accessories. Corporation Catheter, Ureteral, Gastro-Urology EYB Available with exclusive ATRAUM Coating 876.5130 Axiom Medical, Inc. Catheter, Ureteral, Gastro-Urology EYB 876.5130 Bard Canada, Inc. Catheter, Ureteral, Gastro-Urology EYB 876.5130 Cook Urological, Inc. Catheter, Ureteral, Gastro-Urology EYB Various models of catheters ureteral gastro- 876.5130 Dimeda Instrumente Gmbh urology Catheter, Ureteral, Gastro-Urology EYB Foley, Uretheral, & Irrigation Kits & Tray 876.5130 Medikmark Inc. Catheter, Ureteral, Gastro-Urology EYB Catheters. 876.5130 Medline Manufacturing And Services Llc Catheter, Ureteral, Gastro-Urology EYB 876.5130 Merlyn Pharmaceuticals, Inc. Catheter, Ureteral, Gastro-Urology EYB 876.5130 Millar Instruments, Inc. Catheter, Ureteral, Gastro-Urology EYB Foley-temp ureteral catheter 876.5130 Mmj S.A. De C.V. Catheter, Ureteral, Gastro-Urology EYB Ureteral catheter. 876.5130 Reach Global Industries, Inc. (Reachgood) Catheter, Upper Urinary Tract EYC Intermittent urinary catheter. 876.5130 Biosearch Medical Products, Inc. Catheter, Upper Urinary Tract EYC 876.5130 Cook Urological, Inc. Catheter, Upper Urinary Tract EYC Catheter, upper urinary tract. 876.5130 Deroyal Surgical - Rose Hill

Source: MDRWeb.com 126 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Coude EZC 876.5130 Benlan Inc. Catheter, Coude EZC CONVEEN sterile with frosted surface and 876.5130 Coloplast Manufacturing smooth tip for ease of use, lateral eyelets for Us, Llc maximum drainage. Catheter, Coude EZC 876.5130 Merlyn Pharmaceuticals, Inc. Catheter, Straight EZD Urine catheter kit. 876.5130 Busse Hospital Disposables, Inc. Catheter, Straight EZD Introducers. 876.5130 Clinical Instruments Intl., Inc. Catheter, Straight EZD 876.5130 Cook Urological, Inc. Catheter, Straight EZD 876.5130 Covidien Lp Catheter, Straight EZD Urological neonatal catheter and 876.5130 Neo-Care Arrow International urological drainage kit. Catheter, Straight EZD Urology catheter. 876.5130 Percutaneous Systems, Incorporated Catheter, Retention Type EZK 876.5980 Cook Urological, Inc. Catheter, Retention Type EZK 876.5980 Porges S.A. Catheter, Retention Type EZK Catheter pads 876.5980 Tmp Technologies, Inc. Catheter, Retention Type, Balloon EZL 876.5130 Cook Urological, Inc. Catheter, Retention Type, Balloon EZL 876.5130 Covidien Lp Catheter, Retention Type, Balloon EZL All silicone foley balloon catheter 876.5130 Create Medic Co., Ltd. Catheter, Retention Type, Balloon EZL Gastrostomy tubes under private label. 876.5130 Degania Silicone, Inc. Catheter, Retention Type, Balloon EZL Foley catheters-silicone, teflon coatef, latex, 876.5130 Kelsar, S.A. silicone elastomer coated Catheter, Retention Type, Balloon EZL Foley catheters. 876.5130 Kentron Health Care, Inc. Catheter, Retention Type, Balloon EZL Silicone balloon. 876.5130 Manufacturing & Research, Inc.(Dba Mri Medical) Catheter, Retention Type, Balloon EZL 876.5130 Medline Industries, Inc. Catheter, Retention Type, Balloon EZL Foley catheters. 876.5130 Medline Manufacturing And Services Llc Catheter, Retention Type, Balloon EZL 876.5130 Merlyn Pharmaceuticals, Inc. Catheter, Retention Type, Balloon EZL Foley catheters 876.5130 Mmj S.A. De C.V. Catheter, Retention Type, Balloon EZL Urinary catheter and accessories. 876.5130 Opticon Medical Catheter, Retention Type, Balloon EZL Various. 876.5130 Rochester Medical Corp. Dilator, Catheter, Ureteral EZN 876.5470 Aesculap Implant Systems Inc. Dilator, Catheter, Ureteral EZN 876.5470 Boston Scientific Corporation Dilator, Catheter, Ureteral EZN 876.5470 C. R. Bard, Inc., Bard Urological Div. Dilator, Catheter, Ureteral EZN Same 876.5470 Combined Instruments (Pvt.), Ltd. Dilator, Catheter, Ureteral EZN 876.5470 Cook Urological, Inc. Dilator, Catheter, Ureteral EZN 876.5470 Martin Gmbh & Co. Kg, Gebr. Dilator, Catheter, Ureteral EZN Sterile catheter for access during 876.5470 Onset Medical Corporation nephrostomy procedures. Dilator, Catheter, Ureteral EZN 876.5470 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Prosthesis, Penile FAE 700 ULTREX and 700 ULTREX PLUS Penile 876.3630 American Medical Systems, Prostheses; AMS 700CX and AMS 700CXM Inc. Inflatable Penile Prostheses; and AMS MALLEABLE 650 and AMS MALLEABLE 600M Penile Prostheses. Prosthesis, Penile FAE Malleable penile prosthesis 876.3630 H.R. Industria Comercio Equipamento Biomed Ltda Prosthesis, Penile FAE DURA II. 876.3630 Timm Medical Technologies, Inc. Light, Catheter, Fiberoptic, Glass, FCS Ureteral illuminator. 876.4020 Apple Medical Corp. Ureteral

Source: MDRWeb.com 127 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Light, Catheter, Fiberoptic, Glass, FCS $95 for arterial fiberoptic catheter. 876.4020 Hospira, Inc. Ureteral Pump, Air, Non-Manual, For FEQ Endoscopy pumps and tubing sets. 876.1500 Frantz Medical Development Endoscope Ltd. Pump, Air, Non-Manual, For FEQ 876.1500 Karl Storz Endoscopy- Endoscope America Inc. Pump, Air, Non-Manual, For FEQ 876.1500 Sensidyne, Inc. Endoscope Catheter, Malecot FEW 876.5090 Abbott Laboratories Catheter, Malecot FEW 876.5090 Cook Inc. Catheter, Malecot FEW 876.5090 Cook Urological, Inc. Catheter, Malecot FEW 876.5090 Dumex Medical Surgical Products Ltd. Catheter, Malecot FEW 876.5090 Merlyn Pharmaceuticals, Inc. Catheter, Malecot FEW Surgical; balloon gastrostomy. 876.5090 Novartis Nutrition Catheter, Malecot FEW 876.5090 Omni Medical Supply Inc. Catheter, Malecot FEW Silicone malecot catheter available in 20,24 876.5090 Technical Products, Inc. and 32 fr sizes. Latex free; not normally used as a gastroscopy tube. Catheter and Tube, Suprapubic FEZ 876.5090 Cook Urological, Inc. Catheter and Tube, Suprapubic FEZ 876.5090 Covidien Lp Catheter and Tube, Suprapubic FEZ 876.5090 Merlyn Pharmaceuticals, Inc. Tube, Drainage, Suprapubic FFA ANDERSEN nasogastric tube with or without 876.5090 Andersen Products, Inc., stylet, double-lumen, radio-opaque with anti-reflux filter. Tube, Drainage, Suprapubic FFA Thoracic, mediastinal, and closed wound 876.5090 Armm, Inc. drains. Tube, Drainage, Suprapubic FFA Suprapubic urological catheter. 876.5090 Bentec Medical, Inc. Tube, Drainage, Suprapubic FFA 876.5090 Bipore, Inc. Tube, Drainage, Suprapubic FFA 876.5090 Boston Scientific Corporation Tube, Drainage, Suprapubic FFA 876.5090 Cook Urological, Inc. Tube, Drainage, Suprapubic FFA 876.5090 Covidien Lp Tube, Drainage, Suprapubic FFA 876.5090 Filtrona Extrusion, Inc./ PexcoÂ® Medical Products Div. Tube, Drainage, Suprapubic FFA Sterile penrose type drain. 876.5090 Geneva Medical Inc. Tube, Drainage, Suprapubic FFA Various sizes. 876.5090 Icu Medical (Ut), Inc Tube, Drainage, Suprapubic FFA 876.5090 Ldb Medical, Inc. Tube, Drainage, Suprapubic FFA 876.5090 Medovations, Inc. Tube, Drainage, Suprapubic FFA Needle, intravenous sre intravadcular. 876.5090 Neo Medical Inc. Tube, Drainage, Suprapubic FFA 876.5090 Porges S.A. Tube, Drainage, Suprapubic FFA 876.5090 Pragoexport Tube, Drainage, Suprapubic FFA C-FLEX, non-latex, penrose drains. 876.5090 Saint-Gobain Performance Plastics/Clearwater Tube, Drainage, Suprapubic FFA Evacuation tubes. 876.5090 Stryker Puerto Rico, Ltd. Tube, Drainage, Suprapubic FFA 876.5090 Sunlite Plastics, Inc. Tube, Drainage, Suprapubic FFA Suprapubic - see drain, penrose. 876.5090 Taut, Inc. Tube, Drainage, Suprapubic FFA 60in., 9/32in. lumen vinyl drainage tube. 876.5090 Urocare Products, Inc. Also, extension tube with connector. Tube, Drainage, Suprapubic FFA CLINVAC closed wound drainage. Silicone 876.5090 Yushin Medical Co., Ltd. and P.V.C. containers available. Silicone container for 100ml - 200ml. P.V.C. container for 200ml - 800ml. Ventricular drainage silicone tubing. Tube, Drainage, Suprapubic FFA 876.5090 Zimmer Holdings, Inc. Tube, Drainage, Suprapubic FFA HEMOVAC. 876.5090 Zimmer Orthopaedic Surgical Products

Source: MDRWeb.com 128 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Biliary, Diagnostic FGE Biliary catheter and accessories. 876.5010 Abbott Vascular Inc. Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 Abbott Vascular, Cardiac Therapies Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 Abbott Vascular, Vascular Solutions Catheter, Biliary, Diagnostic FGE Biliary stone retrieval device, lavaging, 876.5010 Angiomed Gmbh & Co. catheters, endoscopic retrograde cholo Medizintechnik Kg Catheter, Biliary, Diagnostic FGE 876.5010 Applied Medical Resource Corporation Catheter, Biliary, Diagnostic FGE Various ercp catheters. 876.5010 Ballard Medical Products Catheter, Biliary, Diagnostic FGE Biliary catheter. 876.5010 Bentec Medical, Inc. Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 Biosearch Medical Products, Inc. Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 Boston Scientific - Marina Bay Customer Fulfillment Center Catheter, Biliary, Diagnostic FGE DIAGNOSTIC - Sentinol 876.5010 Boston Scientific Corp. Catheter, Biliary, Diagnostic FGE Biliary drainage catheters for use in 876.5010 Boston Scientific Corporation radiology. Catheter, Biliary, Diagnostic FGE Biliary stent 876.5010 Boston Scientific Ireland, Ltd. Catheter, Biliary, Diagnostic FGE 876.5010 C. R. Bard, Inc., Bard Urological Div. Catheter, Biliary, Diagnostic FGE Stone removal balloons, biliary balloon 876.5010 ConMed Endoscopic dilators. Technologies Catheter, Biliary, Diagnostic FGE Various types of sterile biliary catheters 876.5010 Cook Endoscopy including biliary and. Catheter, Biliary, Diagnostic FGE 876.5010 Cook Inc. Catheter, Biliary, Diagnostic FGE CHOLE-CATH biliary catheter. 876.5010 Covidien Lp Catheter, Biliary, Diagnostic FGE 876.5010 Edwards Lifesciences, Llc. Catheter, Biliary, Diagnostic FGE Bonastent Biliary by Sewoon Medical; 876.5010 Endochoice Inc. Bonastent Biliary designed by SST; Bonastent manufactured by Sewoon; EndoChoice Bonastent Biliary stent Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 Ev3 Inc. Catheter, Biliary, Diagnostic FGE Biliary Self Expanding Stent System 876.5010 Flexible Stenting Solutions Inc. Catheter, Biliary, Diagnostic FGE DIAGNOSTIC - VIADUCT 876.5010 Gi Supply Catheter, Biliary, Diagnostic FGE Various types of biliary catheters and 876.5010 Gip Medizin Technik Gmbh accessories Catheter, Biliary, Diagnostic FGE HEMEDEX FIXATION DEVICE 876.5010 Hemedex Incorporated Catheter, Biliary, Diagnostic FGE Biliary stent set. 876.5010 Hobbs Medical, Inc. Catheter, Biliary, Diagnostic FGE Precise RX Nitinol Stent; SMART Control 876.5010 Johnson & Johnson Catheter, Biliary, Diagnostic FGE Biliary catheter. 876.5010 Lucas Medical, Inc. Catheter, Biliary, Diagnostic FGE DIAGNOSTIC - Bridge Aurora Biliary Stent 876.5010 Medtronic Vascular System; MULTIPLE Catheter, Biliary, Diagnostic FGE Biliary stent system. 876.5010 Orbusneich Medical, Inc. Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 Specialty Surgical Products, Inc. Catheter, Biliary, Diagnostic FGE CHOLE-CATH percutaneous. 876.5010 Uresil, Llc Catheter, Biliary, Diagnostic FGE Biliary stent. 876.5010 W.L. Gore & Associates,Inc Catheter, Biliary, Diagnostic FGE 876.5010 Wilson-Cook Medical, Inc. Catheter, Ureteral Disposable FGF 876.5130 Cook Urological, Inc. (X-Ray) Catheter, Ureteral Disposable FGF 876.5130 Covidien Lp (X-Ray) Catheter, Ureteral Disposable FGF 876.5130 Porges S.A. (X-Ray) Catheter, Ureteral Disposable FGF SURGIFLEX Ureteral Catheters of different tip 876.5130 Surgimedik (X-Ray) configuration

Source: MDRWeb.com 129 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pump, Blood, Extra-Luminal FIR Peristaltic plasma pump. 876.5820 Apheresis Technologies, Inc. Pump, Blood, Extra-Luminal FIR MINIPUMP. 876.5820 Minntech Corporation Guard, Shunt FJM No common name listed 876.5540 Kuraray Kurashiki Plant Catheter, Peritoneal, Long-Term FJS Neonatal, pediatric, adult, and custom 876.5630 Angiodynamics, Inc. Indwelling configurations in 16 silicone models including coiled, straight, and variable, with one universal placement kit. Catheter, Peritoneal, Long-Term FJS Various 876.5630 Bard Reynosa S.A. De C.V. Indwelling Catheter, Peritoneal, Long-Term FJS Various sizes of sterile and non-sterile 876.5630 Hakko Medical Co., Ltd. Indwelling catheter Catheter, Peritoneal, Long-Term FJS 876.5630 Lifemed Of California Indwelling Connector, Blood Tubing, Infusion T FKB Heparin t connector 876.5820 Erika De Reynosa, S.A. De C.V. Connector, Blood Tubing, Infusion T FKB 876.5820 Lifemed Of California Connector, Blood Tubing, Infusion T FKB 876.5820 Mabis Healthcare Inc. Connector, Blood Tubing, Infusion T FKB 876.5820 Novosci Corp. Connector, Blood Tubing, Infusion T FKB 876.5820 Np Medical, Inc. Connector, Blood Tubing, Infusion T FKB Y connector. 876.5820 Stryker Puerto Rico, Ltd. Connector, Blood Tubing, Infusion T FKB 876.5820 Vygon Corp. Connector, Blood Tubing, Infusion T FKB Sterile extension tubing 876.5820 Vygon S A Adaptor, Shunt FKN 876.5540 Codman & Shurtleff, Inc Adaptor, Shunt FKN 876.5540 Lifemed Of California Adaptor, Shunt FKN Shunts for neurological use. 876.5540 Schmidt-Medizintechnik Gmbh Catheter, Peritoneal Dialysis, Single- FKO Acute hemodialysis kit. 876.5630 Argon Medical Devices Inc. Use Catheter, Peritoneal Dialysis, Single- FKO Sterile peritoneal dialysis catheter. 876.5630 B. Braun Of Puerto Rico, Inc. Use Catheter, Peritoneal Dialysis, Single- FKO Peritoneal dialysis catheter. 876.5630 Corpak Medsystems, Inc. Use Catheter, Peritoneal Dialysis, Single- FKO Peritoneal dialysis catheter 876.5630 Gujarat Surgico, Ltd. Use Catheter, Peritoneal Dialysis, Single- FKO 876.5630 Lifemed Of California Use Catheter, Peritoneal Dialysis, Single- FKO Stab peritoneal catheters for adult and 876.5630 Surgimedik Use pediatric Catheter, Peritoneal Dialysis, Single- FKO 876.5630 Vygon Corp. Use Catheter, Peritoneal Dialysis, Single- FKO Hemodialysis catheter (sterile) 876.5630 Vygon S A Use Stopcock, I.V. Set FMG Plastic disposable non-sterile stop cock. 880.5440 Ac Healthcare Supply, Inc. Stopcock, I.V. Set FMG Similar models of stopcocks 880.5440 B. Braun Medical Ag Stopcock, I.V. Set FMG OTHER; DISCOFIX 880.5440 B. Braun Medical, Inc. Stopcock, I.V. Set FMG 880.5440 B. Braun Oem Division, B. Braun Medical Inc. Stopcock, I.V. Set FMG Iv set stopcock. 880.5440 B. Braun Of Puerto Rico, Inc. Stopcock, I.V. Set FMG Stopcock, various types 880.5440 Baur Und Haselbarth-Chirurg Gmbh Stopcock, I.V. Set FMG I.V. SET - Multi-Port Manifold; Stopcock 880.5440 Baxter Healthcare Manifold Gangs; Corporation, Medication Delivery Stopcock, I.V. Set FMG 880.5440 Baxter Healthcare Corporporation, Alternate Care And Channel Team Stopcock, I.V. Set FMG Various stopcocks. 880.5440 Baxter Healthcare S.A. Stopcock, I.V. Set FMG Various designs & combinations of plastic 880.5440 Baxter Productos Medicos, stopcocks Ltda.

Source: MDRWeb.com 130 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Stopcock, I.V. Set FMG PTFs, various types & sizes 880.5440 Berghof/America Stopcock, I.V. Set FMG Metal stopcocks in 30 sizes. 880.5440 Cadence Science Inc. Stopcock, I.V. Set FMG 880.5440 Caremed Medical Products Ag Stopcock, I.V. Set FMG 880.5440 Churchill Medical Systems, Inc. Stopcock, I.V. Set FMG 880.5440 Cook Inc. Stopcock, I.V. Set FMG I.V. SET - Plas. Stck. w/extension tube/steril; 880.5440 Covidien MULTIPLE Stopcock, I.V. Set FMG 880.5440 Covidien Lp Stopcock, I.V. Set FMG 880.5440 David Scott Company Stopcock, I.V. Set FMG 880.5440 Directmed, Inc. Stopcock, I.V. Set FMG Stopcock, i.v. set. 880.5440 Edwards Lifesciences Technology Sarl Stopcock, I.V. Set FMG 880.5440 Elcam Medical, Inc. Stopcock, I.V. Set FMG 880.5440 Ernst Flow Industries Stopcock, I.V. Set FMG No common name listed 880.5440 Farmatap S.A. De C.V. Stopcock, I.V. Set FMG MULTIPLE 880.5440 Hospira Inc. Stopcock, I.V. Set FMG INTRALOCK disposable stopcock. 880.5440 Hospira, Inc. Stopcock, I.V. Set FMG Intravascular administrtion set. 880.5440 Icu Medical (Ut), Inc Stopcock, I.V. Set FMG Intravascular administration set. 880.5440 Icu Medical, Inc. Stopcock, I.V. Set FMG Ultraconcentrator manifold with extension 880.5440 Interpore Cross International set. Graft delivery syringe. Disposable system for intraoperative collection of autologous growth factors. Stopcock, I.V. Set FMG Stopcocks and iv sets. 880.5440 Kentron Health Care, Inc. Stopcock, I.V. Set FMG 880.5440 Kontes Glass Co. Stopcock, I.V. Set FMG Various types of stopcocks with luer lock 880.5440 Merit Medical Systems, Inc. adapters. Stopcock, I.V. Set FMG 880.5440 Microgroup Stopcock, I.V. Set FMG 880.5440 Mps Acacia Stopcock, I.V. Set FMG 880.5440 Novosci Corp. Stopcock, I.V. Set FMG 880.5440 S4j Manufacturing Services, Inc. Stopcock, I.V. Set FMG No common name listed 880.5440 Schad Medical Instruments Gmbh Stopcock, I.V. Set FMG HYPERAL stopcock, extension sets and 880.5440 Smiths Medical OEM T-connector. Stopcock, I.V. Set FMG 880.5440 Sorin Group Usa Stopcock, I.V. Set FMG Three way stopcock. 880.5440 Terumo Medical Corporation Stopcock, I.V. Set FMG Stopcock and stopcock adapter. 880.5440 Unimed S.A. Stopcock, I.V. Set FMG Disposable stopcocks. 880.5440 Vygon Corp. Stopcock, I.V. Set FMG Sterile stopcocks 880.5440 Vygon S A Catheter, Umbilical Artery FOS Umbilical catheter 880.5200 Baxter Productos Medicos, Ltda. Catheter, Umbilical Artery FOS Various sizes of sterile catheters. 880.5200 Covidien Lp, Formerly Registered As Kendall Catheter, Umbilical Artery FOS Accessory to intravascular catheter. 880.5200 Health Care Logistics, Inc. Catheter, Umbilical Artery FOS UMBILI-CATH, umbilical vessel & umbilical 880.5200 Utah Medical Products, Inc. artery catheters used for administration of meds & monitoring blood pressure invasively. Many sizes, both silicone & polyurethane. Catheter, Umbilical Artery FOS 880.5200 Vygon Corp. Catheter, Umbilical Artery FOS Umbilical artery catheter (sterile) 880.5200 Vygon S A Catheter, Intravascular, Therapeutic, FOZ Various models of orthodontic products. 880.5200 All Star Orthodontics, Llc Short-term Less Than 30 Days

Source: MDRWeb.com 131 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Intravascular, Therapeutic, FOZ Various central lines sterile. 880.5200 Alsius Corp. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Flush syringes. 880.5200 Amsino Medical Usa Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Central catheter, central venous catheter, 880.5200 Argon Medical Devices Inc. Short-term Less Than 30 Days kit & tray. Catheter, Intravascular, Therapeutic, FOZ Intravascular catheter. 880.5200 Arkray Factory Usa, Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various intravascular catheters 880.5200 Arrow Internacional De Short-term Less Than 30 Days Mexico, S.A. De C.V. Catheter, Intravascular, Therapeutic, FOZ Various 880.5200 As Advanced Medical Short-term Less Than 30 Days Systems Catheter, Intravascular, Therapeutic, FOZ 880.5200 B. Braun Medical Inc., Renal Short-term Less Than 30 Days Therapies Div. Catheter, Intravascular, Therapeutic, FOZ Various 880.5200 Bard Reynosa S.A. De C.V. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 0.9% SODIUM CHLORIDE INJECTION ; BD 880.5200 Becton Dickinson And Co. Short-term Less Than 30 Days Posiflush Saline Catheter, Intravascular, Therapeutic, FOZ 0.9% SODIUM CHLORIDE INJECTION ; BD 880.5200 Becton Dickinson And Short-term Less Than 30 Days Posiflush Saline Company Catheter, Intravascular, Therapeutic, FOZ Catheter, intravascular, short term.; BD 880.5200 Becton Dickinson Medical Short-term Less Than 30 Days Preefil Flush Syringe; BD Posiflush Heparin Systems Catheter, Intravascular, Therapeutic, FOZ Infusion catheter. 880.5200 Bentec Medical, Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Multiple 880.5200 Catalent Pharma Solutions Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880.5200 Catheter Research, Inc. (Cri) Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880.5200 Centurion Medical Products Short-term Less Than 30 Days Corp. Catheter, Intravascular, Therapeutic, FOZ 880.5200 Cook Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880.5200 Covidien Lp Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ SUNDER CENTRAL VENOUS CATHETER KIT 880.5200 Cw Medical, Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Custom design and manufacturing of 880.5200 Diablo Sales & Marketing, Short-term Less Than 30 Days catheters and specialty guidewires. Guiding Inc. catheters; stent delivery and drug delivery systems. Catheter, Intravascular, Therapeutic, FOZ Central venous catheter kit. 880.5200 Edwards Lifesciences Short-term Less Than 30 Days Technology Sarl Catheter, Intravascular, Therapeutic, FOZ Therapeutic, short-term (less than 30 days).; 880.5200 Edwards Lifesciences, Llc. Short-term Less Than 30 Days MULTIPLE Catheter, Intravascular, Therapeutic, FOZ Various types of sterile infusion catheter & 880.5200 Ev3 Neurovascular Short-term Less Than 30 Days accessories. Catheter, Intravascular, Therapeutic, FOZ Pre-filled saline flush syringe. 880.5200 Excelsior Medical Corp. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Needle 880.5200 Haemonetics Corp. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Multiple 880.5200 Hospira Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ 880.5200 Hospira, Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Various 880.5200 Johnson & Johnson De Short-term Less Than 30 Days Monterrey, Sa De Cv Catheter, Intravascular, Therapeutic, FOZ Various 880.5200 Kofu Factory Of Terumo Short-term Less Than 30 Days Corp. Catheter, Intravascular, Therapeutic, FOZ Catheter, iv, therapeutic, short-term less 880.5200 Kollsut Scientific Corporation Short-term Less Than 30 Days than 30 days.

Source: MDRWeb.com 132 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Intravascular, Therapeutic, FOZ Normal Saline & Heparin I. V. Flush Syringe 880.5200 Medefil, Inc. Short-term Less Than 30 Days (in diff. volumes) - prefilled syringe for single use Catheter, Intravascular, Therapeutic, FOZ 880.5200 Millar Instruments, Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Peripherally inserted central catheters and 880.5200 Navilyst Medical Short-term Less Than 30 Days placement kits. Catheter, Intravascular, Therapeutic, FOZ Intravenous silicone catheter. 880.5200 Neo Medical Inc. Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Neonatal, dual lumen umbilical 880.5200 Neo-Care Arrow International Short-term Less Than 30 Days catheter; pediatric PICC and umbilical catheterization kit. Catheter, Intravascular, Therapeutic, FOZ 880.5200 Patton Medical Devices Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Vents (self sealing) for IV Cathether 880.5200 Porex Technologies Gmbh Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ VANISHPOINT I.V. CATHETER 880.5200 Retractable Technologies, Short-term Less Than 30 Days Inc. Catheter, Intravascular, Therapeutic, FOZ Introducer needle. 880.5200 Stryker Instruments, Short-term Less Than 30 Days Instruments Div. Catheter, Intravascular, Therapeutic, FOZ Intravascular catheter. 880.5200 Terumo Medical Corporation Short-term Less Than 30 Days Catheter, Intravascular, Therapeutic, FOZ Over-the-needle catheter. 880.5200 Thomas Medical Products, Short-term Less Than 30 Days Inc. Catheter, Intravascular, Therapeutic, FOZ 880.5200 Tri-State Hospital Supply Short-term Less Than 30 Days Corp. Catheter, Intravascular, Therapeutic, FOZ Mudicut intrvenous cannula, (various sizes) 880.5200 Tyco Healthcare Ireland Short-term Less Than 30 Days Limited Catheter, Intravascular, Therapeutic, FOZ Sterile short iv cannula 880.5200 Vygon S A Short-term Less Than 30 Days Pump, Infusion FRN 880.5725 3m Co. Pump, Infusion FRN Volumetric pump features selection dial 880.5725 Abbott Laboratories that simplifies the user interface and a mode button for switching from primary to secondary fluid administration. Pump, Infusion FRN Quantum Enteral Nutrition Pump 880.5725 Abbott Laboratories Pump, Infusion FRN Infusion pump. 880.5725 Acist Medical Systems, Inc. Pump, Infusion FRN Specialized repair services for leading 880.5725 Aiv, Inc. (Formerly American infusion pumps. AC Adapters, batteries, Iv) power cords and other service parts also available for sale. Pump, Infusion FRN ENTERAL - 880.5725 Altron, Inc. Pump, Infusion FRN The pneumo-hydraulic capillary infusion 880.5725 Arndorfer Medical Specialties system. Pump, Infusion FRN Arthroscopy pump and various types of 880.5725 Arthrex, Inc. tubing (sterile). Pump, Infusion FRN Multipurpose wound drain, multilumen drain 880.5725 Axiom Medical, Inc. allowing lavage and topical applications while continuing evacuation. Relocation/ repositioning made easy. Multiple sizes. Pump, Infusion FRN 880.5725 B. Braun Oem Division, B. Braun Medical Inc. Pump, Infusion FRN Syringe pump for microfilter/min perfusions. 880.5725 Basi (Bioanalytical Systems, For use with research animals only-- not for Inc.) for humans. Pump, Infusion FRN MICRO FUSE, Dual Rate Infuser: 13-oz, 880.5725 Baxa Corporation portable, battery-operated syringe infuser with two selectable rates of flow. Custom infusers are available.; InFuse T10 Pump, Infusion FRN Various infusion pumps. 880.5725 Baxter Healthcare Corporation Pump, Infusion FRN APII. INFUSO.R. INTERMATE system. INFUS.O.R. 880.5725 Baxter Healthcare Corporporation, Alternate Care And Channel Team

Source: MDRWeb.com 133 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pump, Infusion FRN 880.5725 Belmont Instrument Corp. Pump, Infusion FRN Ambulatory infusion pump. 880.5725 Bionica, Inc. Pump, Infusion FRN Infusion pump 880.5725 Block Medical De Mexico S.A. De C.V. Pump, Infusion FRN 880.5725 Braemar, Inc. Pump, Infusion FRN 880.5725 Brandel Pump, Infusion FRN Multi-infusion. 880.5725 Breg, Inc., An Orthofix Company Pump, Infusion FRN Infiltration system - automatic and syringe 880.5725 Byron Medical delivery. AUTOFUSE 10c multiple injection system. Also available, BIG BAG 3000 and PSI-TEC syringe pump. Pump, Infusion FRN Finesse Insulin Delivery System 880.5725 Calibra Medical Inc. Pump, Infusion FRN Infusion pump 880.5725 Changchun Kangda Medical Supply Co., Ltd. Pump, Infusion FRN Design and development of fluid 880.5725 Cmt, Inc. management systems. Pump, Infusion FRN 880.5725 Codan Portugal - Instrumentos Medicos, Ltda. Pump, Infusion FRN 880.5725 ConMed Linvatec Pump, Infusion FRN 880.5725 Covidien Lp, Formerly Registered As Kendall Pump, Infusion FRN IV EXPRES, CHRONOPUMP infusion pump for 880.5725 Debiotech Sa hospital and ambulatory use, multi mode (PCA, TPN, DOSE, Continuous, Secondary) Pump, Infusion FRN 880.5725 Dma Med-Chem Corporation Pump, Infusion FRN Mechanical infusion pump. 880.5725 Ethox International Pump, Infusion FRN Syringe pump. 880.5725 Excelsior Medical Corp. Pump, Infusion FRN Centrifuge and Diaphragm Pumps. 880.5725 Graymills Corp. Pump, Infusion FRN Peristaltic. 880.5725 Greylor Co. Pump, Infusion FRN OEM and private-labeled infusion bags and 880.5725 Harmac Medical Products, administration sets. Contract manufacturer Inc. of custom infusion disposables. Pump, Infusion FRN Microprocessor controlled. 880.5725 Harvard Apparatus, Inc. Pump, Infusion FRN Multiple 880.5725 Hospira Inc. Pump, Infusion FRN 880.5725 Hospira, Inc. Pump, Infusion FRN Various types of infusion pumps (non-sterile). 880.5725 Icu Medical (Ut), Inc Pump, Infusion FRN Pargwtaral infusor pump 880.5725 Infusion Medix, Ltd. Pump, Infusion FRN Sterile empty pca syringe. 880.5725 International Medication Systems, Ltd. Pump, Infusion FRN Infusion pump and accessories. 880.5725 Iradimed Corporation Pump, Infusion FRN Enteral feeding pumps and accessories 880.5725 Kelsar, S.A. Pump, Infusion FRN Infusion pump. 880.5725 Kmi Kolster Methods, Inc. Pump, Infusion FRN INSULIN - Symphony Meter Remote 880.5725 Lifescan, Inc. Pump, Infusion FRN MTP 1001 $2,375 for general use peristaltic 880.5725 Medical Technology infusion pump. Products, Inc. Pump, Infusion FRN 880.5725 Mediq/Prn Pump, Infusion FRN Various models of portable infusion pumps 880.5725 Medis S.R.L. Pump, Infusion FRN MicroMed MMT-407C; Paradigm Reservoir; 880.5725 Medtronic Minimed MMT-103 Reservoir; MMT-326 Paradigm Reservoir Pump, Infusion FRN SILBERG TISSUE PREPARATION SYSTEM: 880.5725 Mettler Electronics Corp. consists of a peristaltic pump to infuse saline subcutaneously and disperse the saline into deeper tissues using ultrasound, $15,000. Pump, Infusion FRN COMPUFLO 880.5725 Milestone Scientific Inc.

Source: MDRWeb.com 134 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pump, Infusion FRN IV-PUSH spring operated, constant pressure 880.5725 Mtm Health Products Ltd. infusor with variable flow from 10ml per hour to 120ml per minute. Pump, Infusion FRN Pneumohydraulic capillary infusion system 880.5725 Mui Scientific for gastro-intestinal manometric studies. 8 Channel Electric US $4,050.00. 8 Channel Nitrogen US $3,450.00. Pump, Infusion FRN No common name listed 880.5725 Nikkiso Co. Ltd. Pump, Infusion FRN Rental of equipment. 880.5725 Omni Medical Supply Inc. Pump, Infusion FRN $207.00 for pole mounted drug pump; 880.5725 Razel Scientific Instruments, $444.00 for ICU pump; also, oxytocin flow Inc. rate chart optional. Pump, Infusion FRN 880.5725 Sigma International, Llc. Pump, Infusion FRN SMISSON-CARTLEDGE TIS-120; ThermaCor 880.5725 Smisson-Cartledge 1200; TIS-1200 Thermal Infusion System Biomedical Pump, Infusion FRN Infusion pump and accessories. 880.5725 Smith & Nephew Inc., Endoscopy Div. Pump, Infusion FRN 880.5725 Sparton Corporation Pump, Infusion FRN Peristaltic. 880.5725 Specialty Manufacturing Co., The Pump, Infusion FRN Peristaltic pumps: routine lab use and 880.5725 Spectrum Laboratories, Inc. chromatography applications. Pump, Infusion FRN 880.5725 Spencer Italia S.R.L. Pump, Infusion FRN Various models of infusion pumps and 880.5725 Stryker Instruments, accessories. Instruments Div. Pump, Infusion FRN Infusion pump. 880.5725 Stryker Puerto Rico, Ltd. Pump, Infusion FRN SURGI-PRESS PRESSURE INFUSION; MULTIPLE 880.5725 Sts Division Of Ethox International Pump, Infusion FRN SMART peristaltic pump, non influsion. 1,2,3 880.5725 Tecan Systems or 4 channel with 8 rollers. Pump, Infusion FRN 880.5725 Terumo Cardiovascular Systems, Corp Pump, Infusion FRN Ambulatory infusion pump. 880.5725 Universal Medical Technologies Pump, Infusion FRN Infusion pump. 880.5725 Valeritas, Llc Pump, Infusion FRN Various models of infusion pumps. 880.5725 Walkmed Infusion Llc Pump, Infusion FRN 880.5725 Wells Johnson Co. Pump, Infusion FRN 880.5725 World Precision Instruments (W.P.I.), Inc. Mesh, Surgical, Polymeric FTL MULTIPLE 878.3300 American Medical Systems, Inc. Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Anulex Technologies, Inc Mesh, Surgical, Polymeric FTL SURGICAL MESH--polypropylene hernia 878.3300 Atrium Medical Corp. mesh in a variety of shapes and sizes for both open and laparoscopic repair of hernias. Mesh, Surgical, Polymeric FTL Abdominal wound care dressing. 878.3300 Avail Medical Products, Inc. Mesh, Surgical, Polymeric FTL Meshes,flats,plugs. 878.3300 Bard Shannon Limited Mesh, Surgical, Polymeric FTL Silo bag. 878.3300 Bentec Medical, Inc. Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Boston Scientific - Marina Bay Customer Fulfillment Center Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Bridger Biomed, Inc. Mesh, Surgical, Polymeric FTL Desara 878.3300 Caldera Medical Inc. Mesh, Surgical, Polymeric FTL Various 878.3300 Cardial, S.A. Mesh, Surgical, Polymeric FTL Hernia Repair and soft tissue reinforcement 878.3300 Cook Biotech, Incorporated Mesh, Surgical, Polymeric FTL DEXON absorbable polyglycolic acid mesh. 878.3300 Covidien Lp Mesh, Surgical, Polymeric FTL 878.3300 Covidien Lp, Formerly Registered As United States Surgical

Source: MDRWeb.com 135 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Mesh, Surgical, Polymeric FTL Implantable surgical mesh. 878.3300 Covidien Lp, Formerly Registered As United States Surgical Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Davol Inc., Sub. C.R. Bard, Inc. Mesh, Surgical, Polymeric FTL PROLENE and MERSIENE mesh, available in 878.3300 Ethicon Endo-Surgery, Inc. sizes including 12in. x 12in., 6in. x 6in., 2.5in. x 4.5in. Mesh, Surgical, Polymeric FTL (sterile, polymeric mesh). 878.3300 Ethicon Endo-Surgery, Inc. Mesh, Surgical, Polymeric FTL Absorbable and non-absorbable mesh 878.3300 Ethicon, Inc. available in various sizes. Mesh, Surgical, Polymeric FTL Sterile, polymeric, mesh. 878.3300 Ethicon, Llc. Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Generic Medical Device, Inc. Mesh, Surgical, Polymeric FTL Mesh (synthetic, absorbable, surgical, 878.3300 Kelsar, S.A. knitted) Mesh, Surgical, Polymeric FTL Nonabsorbable propylene surgical mesh. 878.3300 Kollsut Scientific Corporation Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Macropore Biosurgery, Inc. Mesh, Surgical, Polymeric FTL Trelex. 878.3300 Maquet Cardiovascular LLC Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 Mast Biosurgery Usa Inc. Mesh, Surgical, Polymeric FTL Sterile surgical mesh devices. 878.3300 Minnesota Medical Development, Inc. Mesh, Surgical, Polymeric FTL SUPRAMESH $62.50 for 15x15 cm non-sterile 878.3300 S Jackson Inc. mesh. Two sheets/box. Mesh, Surgical, Polymeric FTL 878.3300 Salts Healthcare Mesh, Surgical, Polymeric FTL Rotator cuff. 878.3300 Shelhigh, Inc. Mesh, Surgical, Polymeric FTL Ventral wall defect reduction silo. 878.3300 Specialty Surgical Products, Inc. Mesh, Surgical, Polymeric FTL 878.3300 Synovis Surgical Innovations Mesh, Surgical, Polymeric FTL Various types and sizes of polymeric surgical 878.3300 Synthes (Usa) - Development mesh. Center Mesh, Surgical, Polymeric FTL Soft tissue repair matrix. 878.3300 Tei Biosciences Inc. Mesh, Surgical, Polymeric FTL Multiple 878.3300 Tyco Healthcare Uk Ltd. Mesh, Surgical, Polymeric FTL Polymeric surgical mesh. 878.3300 TYRX, Inc. Mesh, Surgical, Polymeric FTL Multiple. 878.3300 Ussc Puerto Rico, Inc. Mesh, Surgical, Polymeric FTL Surgical mesh. 878.3300 W.L. Gore & Associates,Inc Mesh, Surgical, Polymeric FTL Staple line reinforcement material. 878.3300 W.L. Gore & Associates,Inc Mesh, Surgical FTM Surgical mesh. 878.3300 Brennen Medical, Llc Mesh, Surgical FTM Surgical mesh. 878.3300 Carbon Medical Technologies, Inc. Mesh, Surgical FTM Soft tissue graft. 878.3300 Cook Endoscopy Mesh, Surgical FTM Stratasis & Surgisis. 878.3300 Cook Urological, Inc. Mesh, Surgical FTM Surgical mesh. 878.3300 Covidien Lp, Formerly Registered As United States Surgical Mesh, Surgical FTM PROPATCH SOFT TISSUE REPAIR MATRIX 878.3300 Cryolife, Inc. Mesh, Surgical FTM Various types of surgical mesh. 878.3300 Depuy Orthopaedics, Inc. Mesh, Surgical FTM 878.3300 Ethicon, Inc. Mesh, Surgical FTM Various 878.3300 Herniamesh Mesh, Surgical FTM Metallic bone fixation appliance or surgical 878.3300 Medtronic Neurosurgery mesh. Mesh, Surgical FTM Sterile surgical mesh. 878.3300 Pegasus Biologics, Inc. Mesh, Surgical FTM Soft tissue repair. 878.3300 Shelhigh, Inc. Mesh, Surgical FTM 878.3300 Stryker Spine Mesh, Surgical FTM Peri-Guard; Peri-Strips Sleeve; Peri-Strips Strip; 878.3300 Synovis Life Technologies, Inc Supple Peri-Guard

Source: MDRWeb.com 136 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Mesh, Surgical FTM Various types and sizes of surgical mesh. 878.3300 Synthes (Usa) - Development Center Mesh, Surgical FTM Surgical mesh. 878.3300 Tei Biosciences Inc. Mesh, Surgical FTM Cement restrictor 878.3300 Teknimed Sa Mesh, Surgical FTM Staple line reinforcement material. 878.3300 W.L. Gore & Associates,Inc Mesh, Surgical FTM 878.3300 Zimmer Holdings, Inc. Mesh, Surgical FTM Hedrocel trabecular metal reconstructive 878.3300 Zimmer Trabecular Metal system. Technology Prosthesis, Chin, Internal FWP Silicone elastomer chin implant. 878.3550 Aesthetic And Reconstructive Technologies, Inc. Prosthesis, Chin, Internal FWP 878.3550 Allergan Prosthesis, Chin, Internal FWP 878.3550 Allied Biomedical Prosthesis, Chin, Internal FWP Various sizes of internal chin prostheses 878.3550 Genetis S.A. Prosthesis, Chin, Internal FWP Chin implant - silicone. 878.3550 Hanson Medical, Inc. Prosthesis, Chin, Internal FWP Chin implant. 878.3550 Invotec Intl. Prosthesis, Chin, Internal FWP Various types of sterile chin prostheses. 878.3550 Mentor Texas, Inc. Prosthesis, Chin, Internal FWP Various. 878.3550 Pillar Surgical, Inc. Prosthesis, Chin, Internal FWP SUPRAMESH $38.50 polyamide mentoplasty 878.3550 S Jackson Inc. implant (3 sizes). Prosthesis, Chin, Internal FWP Chin implants, sterile. Esigned to augment 878.3550 Spectrum Designs Medical, the chin area. Inc. Prosthesis, Chin, Internal FWP Chin implant, straith, 5 different sizes. 878.3550 Surgical Technology Laboratories Inc. Prosthesis, Ear, Internal FZD 878.3590 Bausch & Lomb Surgical Prosthesis, Ear, Internal FZD Same 878.3590 Combined Instruments (Pvt.), Ltd. Prosthesis, Ear, Internal FZD Custom earmolds. 878.3590 Earmold Design, Inc. Prosthesis, Ear, Internal FZD Ear prosthesis [glue-on not implants]. 878.3590 Rocky Mountain Anaplastology, Inc. Prosthesis, Nose, Internal FZE Silicone elastomer nasal implant. 878.3680 Aesthetic And Reconstructive Technologies, Inc. Prosthesis, Nose, Internal FZE 878.3680 Allied Biomedical Prosthesis, Nose, Internal FZE Various sizes of dorsal nasal implants 878.3680 Genetis S.A. Prosthesis, Nose, Internal FZE Various. 878.3680 Gyrus Ent L.L.C., Sub. Of Gyrus Acmi, Inc. Prosthesis, Nose, Internal FZE Dorsal columella or dorsum. 878.3680 Hanson Medical, Inc. Prosthesis, Nose, Internal FZE Nasel implant. 878.3680 Invotec Intl. Prosthesis, Nose, Internal FZE Various types of sterile rhinoplasty 878.3680 Mentor Texas, Inc. prostheses. Prosthesis, Nose, Internal FZE Various. 878.3680 Pillar Surgical, Inc. Prosthesis, Nose, Internal FZE Nose prosthesis (external). 878.3680 Rocky Mountain Anaplastology, Inc. Prosthesis, Nose, Internal FZE Nasal implants, sterile. Designed to restore 878.3680 Spectrum Designs Medical, the nasal contour. Inc. Prosthesis, Nose, Internal FZE 15 different size straith nasal implant. 878.3680 Surgical Technology Laboratories Inc. Clip, Implantable FZP Implantable clip. 878.4300 Abbott Vascular Inc. Clip, Implantable FZP 878.4300 Aesculap Implant Systems Inc. Clip, Implantable FZP Various types of implantable clips, 878.4300 Biomet, Inc. radiographic markers. Clip, Implantable FZP Implantable clip & delivery system. 878.4300 Cardica, Inc. Clip, Implantable FZP 878.4300 Covidien Lp, Formerly Registered As United States Surgical

Source: MDRWeb.com 137 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Clip, Implantable FZP Multiple. 878.4300 Covidien Lp, Formerly Registered As United States Surgical Clip, Implantable FZP 14G CorMARK Biopsy Site Identifier; Caris 878.4300 Devicor Medical Products Site Marker Inc. Clip, Implantable FZP Multiple 878.4300 Dexide Gmbh Clip, Implantable FZP Various types of sterile and non-sterile 878.4300 Ethicon Endo-Surgery, Inc. ligating clips and appliers. Clip, Implantable FZP Implantable clip. 878.4300 Gyrx, Llc Clip, Implantable FZP Ligating clip 878.4300 Kelsar, S.A. Clip, Implantable FZP Visu-Loc 878.4300 Microline Pentax, Inc. Clip, Implantable FZP ROX Anastomotic Coupler System 878.4300 ROX Medical Clip, Implantable FZP Biopsy site marker. 878.4300 Senorx, Inc. Clip, Implantable FZP Implantable clip and delivery system. 878.4300 St. Jude Medical Atrial Fibrillation Clip, Implantable FZP Ligating clip 878.4300 Tyco Healthcare Uk Ltd. Clip, Implantable FZP Multiple. 878.4300 Ussc Puerto Rico, Inc. Suture, Absorbable, Synthetic, GAM Pga absorbable sutures. 878.4493 Accutome, Inc. Polyglycolic Acid Suture, Absorbable, Synthetic, GAM Various types of sterile opthalmic sutures. 878.4493 Alcon Manufacturing, Ltd. Polyglycolic Acid Suture, Absorbable, Synthetic, GAM Midface lift device and installation tools. 878.4493 Coapt Systems, Inc. Polyglycolic Acid Suture, Absorbable, Synthetic, GAM DEXON S or DEXON II. 878.4493 Covidien Lp Polyglycolic Acid Suture, Absorbable, Synthetic, GAM Suture, absorbable, polyglycolic acid. 878.4493 Demetech Corp. Polyglycolic Acid Suture, Absorbable, Synthetic, GAM Suture anchors. 878.4493 Depuy Mitek, A Johnson & Polyglycolic Acid Johnson Company Suture, Absorbable, Synthetic, GAM Sterile synthetic absorbable sutures. 878.4493 Ethicon Endo-Surgery, Inc. Polyglycolic Acid Suture, Absorbable, Synthetic, GAM Polyglycolic acid surgical suture 878.4493 Huaiyin Medical Instruments Polyglycolic Acid Co., Ltd. Suture, Absorbable, Synthetic, GAM 878.4493 Hu-Friedy Manufacturing Polyglycolic Acid Co., Inc. Suture, Absorbable, Synthetic, GAM Polyglycolic acid sutures w/wo coating, 878.4493 Kelsar, S.A. Polyglycolic Acid braided, synthetic Suture, Absorbable, Synthetic, GAM Absorbable surgical suture, synthetic 878.4493 Kollsut Scientific Corporation Polyglycolic Acid (polyglycolic acid). Suture, Absorbable, Synthetic, GAM Various sizes and lengths of absorbable syn. 878.4493 Lsi Solutions Inc. Polyglycolic Acid polyglycolic acid surgical suture. Suture, Absorbable, Synthetic, GAM 878.4493 Nobles Medical Polyglycolic Acid Technologies, Inc. Suture, Absorbable, Synthetic, GAM Polyglycolic acid sutures w/wo coating, 878.4493 Tyco Healthcare Uk Ltd. Polyglycolic Acid braided, synthetic Suture, Absorbable, Synthetic GAN MULTIPLE 878.4830 Biomet Microfixation Inc. Suture, Absorbable, Synthetic GAN Anchor, suture anchor. 878.4830 Biomet, Inc. Suture, Absorbable, Synthetic GAN Suture 878.4830 Cirugia Peruana S.A. Suture, Absorbable, Synthetic GAN 878.4830 Covidien Lp, Formerly Registered As United States Surgical Suture, Absorbable, Synthetic GAN Absorable lactide-glycolide. 878.4830 Covidien Lp, Formerly Registered As United States Surgical Suture, Absorbable, Synthetic GAN Sterile synthetic, absorbable sutures. 878.4830 Ethicon Endo-Surgery, Inc. Suture, Absorbable, Synthetic GAN PCL monofilament synthetic absorbable 878.4830 Surgical Specialties suture. Corporation Suture, Absorbable, Synthetic GAN Absorable lactide-glycolide 878.4830 Tyco Healthcare Uk Ltd. Suture, Absorbable, Synthetic GAN Multiple. 878.4830 Ussc Puerto Rico, Inc.

Source: MDRWeb.com 138 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Suture, Non-Absorbable, Synthetic, GAR Nylon sutures. 878.5020 Accutome, Inc. Polyamide Suture, Non-Absorbable, Synthetic, GAR Various types of sterile opthalmic sutures. 878.5020 Alcon Manufacturing, Ltd. Polyamide Suture, Non-Absorbable, Synthetic, GAR 878.5020 Alcon Research, Ltd. Polyamide Suture, Non-Absorbable, Synthetic, GAR 878.5020 Ashaway Line & Twine Polyamide Manufacturing Co. Suture, Non-Absorbable, Synthetic, GAR Suture. 878.5020 Boston Scientific Corp. Polyamide Suture, Non-Absorbable, Synthetic, GAR TAC-tite(TM) 878.5020 Core Essence Orthopaedics Polyamide Inc. Suture, Non-Absorbable, Synthetic, GAR SURGILON braided nylon; DERMALON 878.5020 Covidien Lp Polyamide monofilament nylon. Suture, Non-Absorbable, Synthetic, GAR 878.5020 Covidien Lp, Formerly Polyamide Registered As United States Surgical Suture, Non-Absorbable, Synthetic, GAR Various. 878.5020 Covidien Lp, Formerly Polyamide Registered As United States Surgical Suture, Non-Absorbable, Synthetic, GAR Various 878.5020 Davis And Geck Caribe, Ltd. Polyamide Suture, Non-Absorbable, Synthetic, GAR Surgical nylon suture. 878.5020 Demetech Corp. Polyamide Suture, Non-Absorbable, Synthetic, GAR Sterile nylon sutures. 878.5020 Ethicon Endo-Surgery, Inc. Polyamide Suture, Non-Absorbable, Synthetic, GAR 878.5020 Ethicon, Inc. Polyamide Suture, Non-Absorbable, Synthetic, GAR Sterile nylon sutures. 878.5020 Ethicon, Llc. Polyamide Suture, Non-Absorbable, Synthetic, GAR Nylon surgical suture 878.5020 Huaiyin Medical Instruments Polyamide Co., Ltd. Suture, Non-Absorbable, Synthetic, GAR Nylon surgical suture 878.5020 Kelsar, S.A. Polyamide Suture, Non-Absorbable, Synthetic, GAR Nonabsorbable surgical suture usp, 878.5020 Kollsut Scientific Corporation Polyamide monofilament polyamide. Suture, Non-Absorbable, Synthetic, GAR Synthetic polyamide nonabsorbable suture 878.5020 Resorba Chirurgisches Polyamide Nahtmaterial F. Hiltner Gmbh Suture, Non-Absorbable, Synthetic, GAR 878.5020 Rivero & Cia. S.A.I.C., P.L. Polyamide Suture, Non-Absorbable, Synthetic, GAR SUPRAMID available in 8 sizes with full range 878.5020 S Jackson Inc. Polyamide of needle types - priced from $20.75 to $149.50 per dozen. Suture, Non-Absorbable, Synthetic, GAR 878.5020 State Trading Corporation Of Polyamide India, Ltd. Suture, Non-Absorbable, Synthetic, GAR Suture non-absorbable, synthetic, 878.5020 Surgical Specialties Polyamide polyamide, with and without needles. Corporation Suture, Non-Absorbable, Synthetic, GAR Various 878.5020 Tyco Healthcare Uk Ltd. Polyamide Suture, Non-Absorbable, Synthetic, GAR Various. 878.5020 Ussc Puerto Rico, Inc. Polyamide Suture, Non-Absorbable, Synthetic, GAS Gas mixtures medical. 878.5000 Airgas-Southwest, Inc. Polyester Suture, Non-Absorbable, Synthetic, GAS Various types of sterile opthalmic sutures. 878.5000 Alcon Manufacturing, Ltd. Polyester Suture, Non-Absorbable, Synthetic, GAS 878.5000 Alcon Research, Ltd. Polyester Suture, Non-Absorbable, Synthetic, GAS Suture. 878.5000 Arthrex, Inc. Polyester Suture, Non-Absorbable, Synthetic, GAS 878.5000 Ashaway Line & Twine Polyester Manufacturing Co.

Source: MDRWeb.com 139 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Suture, Non-Absorbable, Synthetic, GAS Suture anchor. 878.5000 Biomet, Inc. Polyester Suture, Non-Absorbable, Synthetic, GAS Suture. 878.5000 Boston Scientific Corp. Polyester Suture, Non-Absorbable, Synthetic, GAS Suture 878.5000 Cirugia Peruana S.A. Polyester Suture, Non-Absorbable, Synthetic, GAS TI.CRON silicone treated, braided polyester 878.5000 Covidien Lp Polyester fiber and DACRON braided polyester fiber sutures. Suture, Non-Absorbable, Synthetic, GAS 878.5000 Covidien Lp, Formerly Polyester Registered As United States Surgical Suture, Non-Absorbable, Synthetic, GAS Suture, nonabsorbable, synthetic, polyester. 878.5000 Depuy Mitek, A Johnson & Polyester Johnson Company Suture, Non-Absorbable, Synthetic, GAS Sterile polyester sutures. 878.5000 Ethicon Endo-Surgery, Inc. Polyester Suture, Non-Absorbable, Synthetic, GAS 878.5000 Ethicon, Inc. Polyester Suture, Non-Absorbable, Synthetic, GAS Sterile polyester sutures. 878.5000 Ethicon, Llc. Polyester Suture, Non-Absorbable, Synthetic, GAS Polyester surgical suture 878.5000 Huaiyin Medical Instruments Polyester Co., Ltd. Suture, Non-Absorbable, Synthetic, GAS 878.5000 Hu-Friedy Manufacturing Polyester Co., Inc. Suture, Non-Absorbable, Synthetic, GAS Polyester sutures 878.5000 Kelsar, S.A. Polyester Suture, Non-Absorbable, Synthetic, GAS Various sizes and lengths of nonabsorbable 878.5000 Lsi Solutions Inc. Polyester synthetic polyester surgical suture. Suture, Non-Absorbable, Synthetic, GAS Suture with needle. 878.5000 Regen Biologics, Inc. Polyester Suture, Non-Absorbable, Synthetic, GAS Synthetic polyester nonabsorbable suture 878.5000 Resorba Chirurgisches Polyester Nahtmaterial F. Hiltner Gmbh Suture, Non-Absorbable, Synthetic, GAS Braided/coated braided polyester. 878.5000 State Trading Corporation Of Polyester India, Ltd. Suture, Non-Absorbable, Synthetic, GAS Suture non-absorbable synthetic polyester 878.5000 Surgical Specialties Polyester with and without needles. Corporation Suture, Non-Absorbable, Synthetic, GAS Polyester sutures 878.5000 Tyco Healthcare Uk Ltd. Polyester Suture, Non-Absorbable, Synthetic, GAS Gas mixtures, medical. 878.5000 Welco-Cgi Gas Technologies Polyester Suture, Non-Absorbable, Synthetic, GAT Polyester sutures. 878.5000 Accutome, Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Surgical suture. 878.5000 Anulex Technologies, Inc Polyethylene Suture, Non-Absorbable, Synthetic, GAT Suture. 878.5000 Arthrex, Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Poliester surgical sutures 878.5000 Assut Europe S.P.A. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Various types of nonabsorbable suture. 878.5000 Biomet, Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT 878.5000 Covidien Lp Polyethylene Suture, Non-Absorbable, Synthetic, GAT Various. 878.5000 Covidien Lp, Formerly Polyethylene Registered As United States Surgical Suture, Non-Absorbable, Synthetic, GAT Monofilament polypropylene, polyethylene 878.5000 Cp Medical Corporation Polyethylene and stainless steel sutures. Suture, Non-Absorbable, Synthetic, GAT Various 878.5000 Davis And Geck Caribe, Ltd. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Surgical suture nonabsorbable 878.5000 Demetech Corp. Polyethylene polyethylene.

Source: MDRWeb.com 140 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Suture, Non-Absorbable, Synthetic, GAT Suture knot-tying instrument and reloads. 878.5000 Ethicon Endo-Surgery, Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Nonabsorbable surgical suture usp, coated 878.5000 Kollsut Scientific Corporation Polyethylene & braided polyester. Suture, Non-Absorbable, Synthetic, GAT Suture, nonabsorbable, synthetic, 878.5000 Lsi Solutions Inc. Polyethylene polyethylene. Suture, Non-Absorbable, Synthetic, GAT Opti-Fiber; WedgeLoc; Morphix; WedgeLoc 878.5000 MedShape Solutions Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Bone anchor. 878.5000 Musculoskeletal Transplant Polyethylene Foundation Suture, Non-Absorbable, Synthetic, GAT NeoTract Anchor System; NeoTract 878.5000 NeoTract inc. Polyethylene Cystoscopy kit; UroLift System REF11208; UroLift System REF UL400 Suture, Non-Absorbable, Synthetic, GAT Synthetic polyethylene nonabsorbable 878.5000 Resorba Chirurgisches Polyethylene suture Nahtmaterial F. Hiltner Gmbh Suture, Non-Absorbable, Synthetic, GAT Sterile suturing device. 878.5000 Sutura, Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Polyester suture. 878.5000 Tornier Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Various 878.5000 Tyco Healthcare Uk Ltd. Polyethylene Suture, Non-Absorbable, Synthetic, GAT Sterile suture.; G-CATH TISSUE ANCHO; 878.5000 Usgi Medical Polyethylene G-PROX ENDOSCOPIC GRASPER; g-Prox Endoscopic Grasper; g-Cath Tissue Anchor; MULTIPLE Suture, Non-Absorbable, Synthetic, GAT Various. 878.5000 Ussc Puerto Rico, Inc. Polyethylene Suture, Non-Absorbable, Synthetic, GAW Perclose vascular suture device. 878.5010 Abbott Vascular Inc. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Various types of sterile ophthalmic sutures. 878.5010 Alcon Manufacturing, Ltd. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Suture 878.5010 Cirugia Peruana S.A. Polypropylene Suture, Non-Absorbable, Synthetic, GAW 878.5010 Covidien Lp, Formerly Polypropylene Registered As United States Surgical Suture, Non-Absorbable, Synthetic, GAW Various. 878.5010 Covidien Lp, Formerly Polypropylene Registered As United States Surgical Suture, Non-Absorbable, Synthetic, GAW Various 878.5010 Davis And Geck Caribe, Ltd. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Surgical suture nonabsorbable 878.5010 Demetech Corp. Polypropylene polypropylene. Suture, Non-Absorbable, Synthetic, GAW 878.5010 Ethicon, Inc. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Sterile polypropylene suture. 878.5010 Ethicon, Llc. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Polypropylene surgical suture 878.5010 Huaiyin Medical Instruments Polypropylene Co., Ltd. Suture, Non-Absorbable, Synthetic, GAW 878.5010 Hu-Friedy Manufacturing Polypropylene Co., Inc. Suture, Non-Absorbable, Synthetic, GAW Polypropylene suture 878.5010 Kelsar, S.A. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Featherlift silhouette suture. 878.5010 Kmi Kolster Methods, Inc. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Nonabsorbable surgical suture usp, 878.5010 Kollsut Scientific Corporation Polypropylene monofilament polypropylene. Suture, Non-Absorbable, Synthetic, GAW Various sizes & lengths of nonabsorbable 878.5010 Lsi Solutions Inc. Polypropylene syn. polypropylene surgical suture. Suture, Non-Absorbable, Synthetic, GAW Synthetic polypropylene nonabsorbable 878.5010 Resorba Chirurgisches Polypropylene suture Nahtmaterial F. Hiltner Gmbh Suture, Non-Absorbable, Synthetic, GAW Suture non-absorbable, synthetic, 878.5010 Surgical Specialties Polypropylene polypropylene, with and without needles. Corporation

Source: MDRWeb.com 141 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Suture, Non-Absorbable, Synthetic, GAW Suture applicator. 878.5010 Tornier Inc. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Various 878.5010 Tyco Healthcare Uk Ltd. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Various. 878.5010 Ussc Puerto Rico, Inc. Polypropylene Suture, Non-Absorbable, Synthetic, GAW Suture. 878.5010 W.L. Gore & Associates,Inc Polypropylene Catheter, Ureteral, General & Plastic GBL 876.5130 Applied Medical Resource Surgery Corporation Catheter, Ureteral, General & Plastic GBL Various catheter, ureteral, general & plastic 876.5130 Christian Diener Gmbh. & Surgery surgery Co. K.G. Catheter, Ureteral, General & Plastic GBL Standard and custom designed silicone 876.5130 Degania Silicone, Inc. Surgery catheters. Capabilities include silicone extrusion, liquid injection molding, balloon manufacturing, catheter printing, perforations, tipping and packaging, Catheter, Ureteral, General & Plastic GBL 876.5130 Merlyn Pharmaceuticals, Inc. Surgery Catheter, Ureteral, General & Plastic GBL 876.5130 Porges S.A. Surgery Catheter, Urethral GBM Measuring Catheter 876.5130 American Medical Systems, Inc. Catheter, Urethral GBM Urological catheter. 876.5130 Apogee Medical, Llc Catheter, Urethral GBM Various sizes of urethral catheters 876.5130 Baur Und Haselbarth-Chirurg Gmbh Catheter, Urethral GBM Urethral catheter 876.5130 Baxter Productos Medicos, Ltda. Catheter, Urethral GBM Bulk assembled. 876.5130 Benlan Inc. Catheter, Urethral GBM Urine catheter kit. 876.5130 Busse Hospital Disposables, Inc. Catheter, Urethral GBM 876.5130 Covidien Lp Catheter, Urethral GBM Various models of catheters urethral 876.5130 Dimeda Instrumente Gmbh Catheter, Urethral GBM O’neil sterile field intermittent urinary 876.5130 Hennig Ent. catheter Catheter, Urethral GBM Urethral catherter and kits 876.5130 Kelsar, S.A. Catheter, Urethral GBM 876.5130 Life-Tech, Inc. Catheter, Urethral GBM 876.5130 Martin Gmbh & Co. Kg, Gebr. Catheter, Urethral GBM Catheter,urethral,sterile. 876.5130 Medline Manufacturing And Services Llc Catheter, Urethral GBM Urethral catheter. 876.5130 Medtronic Blood Management Catheter, Urethral GBM 876.5130 Merlyn Pharmaceuticals, Inc. Catheter, Urethral GBM 876.5130 Miltex Inc. Catheter, Urethral GBM Male external catheter system. 876.5130 Momentum Medical Catheter, Urethral GBM 876.5130 Porges S.A. Catheter, Urethral GBM Foley catheter. 876.5130 Reach Global Industries, Inc. (Reachgood) Catheter, Urethral GBM Various sizes of nelaton-type urethral 876.5130 Rochester Medical Corp. catheters. Catheter, Urethral GBM 876.5130 State Trading Corporation Of India, Ltd. Catheter, Rectal GBT Rectal tube 876.5980 Baxter Productos Medicos, Ltda. Catheter, Rectal GBT 876.5980 Benlan Inc. Catheter, Rectal GBT Same 876.5980 Combined Instruments (Pvt.), Ltd. Catheter, Rectal GBT Rectal tube 876.5980 Kelsar, S.A. Catheter, Rectal GBT Rectal irrigation tube-sterile. 876.5980 Neo Medical Inc.

Source: MDRWeb.com 142 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Rectal GBT 876.5980 Porges S.A. Catheter, Rectal GBT 876.5980 Vygon Corp. Catheter, Biliary, Surgical GCA Wilteck biliary stent set, wiltek pancreatic 876.5010 Ballard Medical Products stent set. Catheter, Biliary, Surgical GCA 876.5010 Consumaquip Corporation Catheter, Biliary, Surgical GCA Balloon stone extractor. 876.5010 Cook Endoscopy Catheter, Biliary, Surgical GCA Balloon dilation catheter. 876.5010 Geneva Medical Inc. Catheter, Biliary, Surgical GCA Blood glucose test strips. 876.5010 Gml, Inc. Catheter, Biliary, Surgical GCA 876.5010 Porges S.A. Catheter, Biliary, Surgical GCA 876.5010 Rocket Medical Plc. Staple, Implantable GDW 878.4750 Aesculap Implant Systems Inc. Staple, Implantable GDW Salute. 878.4750 Bard Shannon Limited Staple, Implantable GDW Clip for suturing apparatus. 878.4750 Biomet, Inc. Staple, Implantable GDW 878.4750 ConMed Linvatec Staple, Implantable GDW 878.4750 Covidien Lp, Formerly Registered As United States Surgical Staple, Implantable GDW Various sizes and types of sterile disposable 878.4750 Covidien Lp, Formerly staple cartridges. Registered As United States Surgical Staple, Implantable GDW Stapling device and sterile stainless steel 878.4750 Davol Inc., Sub. C.R. Bard, staple. Inc. Staple, Implantable GDW MicroMARK II Tissue Marker MicroM 878.4750 Devicor Medical Products Inc. Staple, Implantable GDW Surgical staples. 878.4750 Edusa Corp. Staple, Implantable GDW Various types of implantable staples and 878.4750 Ethicon Endo-Surgery, Inc. staplers. Staple, Implantable GDW Williams microclip. 878.4750 Gyrus Ent L.L.C., Sub. Of Gyrus Acmi, Inc. Staple, Implantable GDW INSORB (R) Absorbable Subcuticular Staple 878.4750 Incisive Surgical, Inc. Staple, Implantable GDW Clip / staple / tissue marker. 878.4750 Inrad Staple, Implantable GDW Clip 878.4750 Koscher & Wurtz Gmbh Staple, Implantable GDW Staple. 878.4750 Medchannel Llc Staple, Implantable GDW NeoTract Anchor System; NeoTract 878.4750 NeoTract inc. Cystoscopy kit; UroLift System REF11208; UroLift System REF UL400 Staple, Implantable GDW 878.4750 Okay Industries, Inc. Staple, Implantable GDW Circular stapler. 878.4750 Power Medical Interventions, Inc. Staple, Implantable GDW 878.4750 Safestitch Medical Inc. Staple, Implantable GDW Biopsy site marker. 878.4750 Senorx, Inc. Staple, Implantable GDW Hemorrhage occluder pin. 878.4750 Tools For Surgery, Llc Staple, Implantable GDW Various sizes and types of sterile disposable 878.4750 Ussc Puerto Rico, Inc. staple cartridges. Staple, Implantable GDW Staple. 878.4750 Warsaw Orthopedic, Inc. Plate, Cranioplasty, Preformed, GWO Various types of cranioplasty plates. 882.5320 Biomet, Inc. Alterable Plate, Cranioplasty, Preformed, GWO Bone fixation appliance or surical mesh. 882.5320 Medtronic Neurosurgery Alterable Plate, Cranioplasty, Preformed, GWO Various types and sizes of preformed 882.5320 Synthes (Usa) - Development Alterable alterable cranioplasty plates. Center Plate, Cranioplast, Preformed, Non- GXN Hard tissue replacement-patient matched 882.5330 Biomet Microfixation Inc. Alterable implant. Plate, Cranioplast, Preformed, Non- GXN Hard tissue replacement, patient matched 882.5330 Biomet, Inc. Alterable implant.

Source: MDRWeb.com 143 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Plate, Cranioplast, Preformed, Non- GXN Craniotomy fixation system. 882.5330 Bioplate, Inc. Alterable Plate, Cranioplast, Preformed, Non- GXN Various sizes of craniofacial implants 882.5330 Genetis S.A. Alterable Plate, Cranioplast, Preformed, Non- GXN 882.5330 Stryker Spine Alterable Dura-Substitute GXQ Dura substitute, sterile. 882.5910 Bridger Biomed, Inc. Dura-Substitute GXQ Dura subsitute. 882.5910 Collagen Matrix, Inc. Dura-Substitute GXQ Dural Substitute 882.5910 Cook Biotech, Incorporated Dura-Substitute GXQ Dura substitute. 882.5910 Pegasus Biologics, Inc. Dura-Substitute GXQ Dura substitute. 882.5910 Shelhigh, Inc. Dura-Substitute GXQ Dura-Guard 882.5910 Synovis Life Technologies, Inc Dura-Substitute GXQ DURA-GUARD Dural Repair Patch, a 882.5910 Synovis Surgical Innovations processed bovine pericardial patch for use as a dural substitute for the closure of dura mater during neurosurgery. Dura-Substitute GXQ Dura substitute. 882.5910 W.L. Gore & Associates,Inc Cover, Burr Hole GXR Burr hole cover. 882.5250 Bioplate, Inc. Cover, Burr Hole GXR 882.5250 Codman & Shurtleff, Inc Cover, Burr Hole GXR Burr hole covers. 882.5250 Integra Lifesciences Of Ohio Cover, Burr Hole GXR Todd burr-hole button. 882.5250 Integra Neurosciences Pr Cover, Burr Hole GXR 882.5250 Kls-Martin L.P. Cover, Burr Hole GXR Various types of burr hole covers 882.5250 Medos S.A. Cover, Burr Hole GXR Burr hole cover. 882.5250 Medtronic Image-Guided Neurologics, Inc. Cover, Burr Hole GXR Invisx cranial fixation locks, invisx cranial 882.5250 Medtronic Neurosurgery fixation tools reusable & disposab. Cover, Burr Hole GXR Various types and sizes of burr hole covers. 882.5250 Synthes (Usa) Cover, Burr Hole GXR Burr hole cover. 882.5250 W.L. Gore & Associates,Inc Stimulator, Spinal Cord, Implanted GZB Spinal cord stimulator. 882.5880 Avery Biomedical Devices, (Pain Relief) Inc. Stimulator, Spinal Cord, Implanted GZB Various. 882.5880 Medtronic Neuromodulation (Pain Relief) Stimulator, Spinal Cord, Implanted GZB Various types of sterile and non-sterile spinal 882.5880 Medtronic Puerto Rico (Pain Relief) cord stimulation systems. Operations Co., Juncos Stimulator, Spinal Cord, Implanted GZB Various types of sterile and non-sterile spinal 882.5880 Medtronic Puerto Rico (Pain Relief) cord stimulation systems. Operations Co., Villalba Stimulator, Spinal Cord, Implanted GZB Various types of sterile and non-sterile spinal 882.5880 Medtronic Puerto Rico (Pain Relief) cord stimulation systems. Operations Co.,Med Rel Stimulator, Spinal Cord, Implanted GZB ITREL, ITREL EZ, ITREL 3, ITREL II, PISCES, PISCES- 882.5880 Medtronic, Inc. (Pain Relief) QUAD, PISCES-QUAD PLUS, PISCES QUINTA, PISCES-SELECTRX, PISCES-SIGMA, SYMMIX, X-TREL. Stimulator, Spinal Cord, Implanted GZB Eon Neurostimulation IPG System; Genesis 882.5880 St. Jude Medical (Pain Relief) Neurostimulation IPG System; MULTIPLE Neuromodulation Division Stimulator, Spinal Cord, Implanted GZB Various. 882.5880 Trivirix International Inc. (Pain Relief) Stimulator, Peripheral Nerve, GZF Peripheral nerve stimulator. 882.5870 Avery Biomedical Devices, Implanted (Pain Relief) Inc. Stimulator, Peripheral Nerve, GZF Various. 882.5870 Medtronic Neuromodulation Implanted (Pain Relief) Stimulator, Peripheral Nerve, GZF Various types of sterile and non-sterile 882.5870 Medtronic Puerto Rico Implanted (Pain Relief) peripheral nerve stimulation systems. Operations Co., Villalba Stimulator, Peripheral Nerve, GZF Various types of sterile and non-sterile 882.5870 Medtronic Puerto Rico Implanted (Pain Relief) peripheral nerve stimulation systems. Operations Co.,Med Rel Stimulator, Peripheral Nerve, GZF Wide Spaced Quattrode Leads; Renew 882.5870 St. Jude Medical Implanted (Pain Relief) Neurostimulation System; Neuromodulation Division Stimulator, Peripheral Nerve, GZF Various. 882.5870 Trivirix International Inc. Implanted (Pain Relief)

Source: MDRWeb.com 144 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Clip, Implanted Malleable HBP Various implanted malleable clips. 882.5225 Depuy-Raynham, A Div. Of Depuy Orthopaedics Catheter, Ventricular HCA 882.4100 Codman & Shurtleff, Inc Catheter, Ventricular HCA Hummingbird Multi-Parameter with 882.4100 Innerspace, Inc. OxiPort. Provides concurrent monitoring of ICP, Oxygen, Temperature while providing ventricular drainage through a single burr- hole. Catheter, Ventricular HCA Various sites and configurations. 882.4100 Integra Neurosciences Pr Catheter, Ventricular HCA Aspiration/irrigation catheter. 882.4100 Medtronic Image-Guided Neurologics, Inc. Catheter, Ventricular HCA Ventricular catheter, flanged. 882.4100 Medtronic Neurosurgery Catheter, Ventricular HCA 882.4100 Millar Instruments, Inc. Device, Neurovascular Embolization HCG Embolic agent sterile. 882.5950 Biocure, Inc. Device, Neurovascular Embolization HCG Embolization device. 882.5950 Biosphere Medical, Inc. Device, Neurovascular Embolization HCG Detachable emolic coil 882.5950 Boston Scientific Cork Ltd. Device, Neurovascular Embolization HCG Spheres or emboli. 882.5950 Boston Scientific- Neurovascular Device, Neurovascular Embolization HCG Embolization device. 882.5950 Cordis Neurovascular, Inc. Device, Neurovascular Embolization HCG Side-branch-occlusion system. 882.5950 Edwards Lifesciences, Llc. Device, Neurovascular Embolization HCG Neurovascular embolization device. 882.5950 Ev3 Neurovascular Device, Neurovascular Embolization HCG Ivalon PVA Embolization Particles for 882.5950 Ivalon, Inc. permanent therapeutic occlusion and preoperative occlusion of arteriovenous malformations (AVMs) and hypervascular tumors. Device, Neurovascular Embolization HCG NEUROVASCULAR - CONTOUR 882.5950 Maquet Cardiovascular LLC Device, Neurovascular Embolization HCG Embolization coil. 882.5950 Microvention, Inc. Device, Neurovascular Embolization HCG MicroCoils and microcatheters for use in 882.5950 Micrus Corporation embolization of cerebral aneurysms. Device, Neurovascular Embolization HCG Catheter system for delivery of embolic coil 882.5950 Micrus Endovascular systems. Corporation Device, Neurovascular Embolization HCG PVA foam embolization particles. 882.5950 Surgica Corporation Aspirator, Endocervical HFC 884.1050 Genx International Aspirator, Endocervical HFC 884.1050 Ipas Aspirator, Endocervical HFC Cervical mucus sampling device. 884.1050 Medical Systems, Inc. Aspirator, Endocervical HFC $7.50 (less than 25) per unit (standard) in 884.1050 Milex Products, Inc. boxes of 25 units; $156.20/box. Aspirator, Endocervical HFC 884.1050 Rocket Medical Plc. Aspirator, Endocervical HFC SELECTMUCUS. 884.1050 Select Medical Systems Aspirator, Endocervical HFC 884.1050 Thomas Medical Inc. Aspirator, Endocervical HFC 884.1050 Wisap Gesellschaft Fur Wisseusch Apparatebau M.B.H. Aspirator, Endometrial HFF Endometrial aspirator 884.1060 Gynetics Medical Products Nv Aspirator, Endometrial HFF 884.1060 Ipas Aspirator, Endometrial HFF Various devices ranging in price from $3 to 884.1060 Milex Products, Inc. $15 each. Aspirator, Endometrial HFF 884.1060 Rocket Medical Plc. Aspirator, Endometrial HFF Endometrial aspirator: Zinnanti Endometrial 884.1060 Thomas Medical Inc. Curette, disposable endometrial suction curette. Aspirator, Endometrial HFF 884.1060 Wisap Gesellschaft Fur Wisseusch Apparatebau M.B.H. Catheter, Intrauterine and HGS Various types of catheter introducers 884.2700 Baur Und Haselbarth-Chirurg Introducer Gmbh

Source: MDRWeb.com 145 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Intrauterine and HGS KOALA Intrauterine pressure system is a 884.2700 Clinical Innovations, Inc. Introducer sensor-tip catheter designed with a small, soft tip for safe and easy insertion. Cables and telemetry system available. Catheter, Intrauterine and HGS Same 884.2700 Combined Instruments (Pvt.), Introducer Ltd. Catheter, Intrauterine and HGS 884.2700 Conceptus, Inc. Introducer Catheter, Intrauterine and HGS Intrauterine catheter 884.2700 Laboratoires Prodimed Introducer Catheter, Intrauterine and HGS 884.2700 Rocket Medical Plc. Introducer Catheter, Intrauterine and HGS INTRAN trasducer-tipped intra-uterine 884.2700 Utah Medical Products, Inc. Introducer pressure catheter for uterine monitoring during labor; also, a complete line of transducer-tipped and fluid-filled catheters. Implant, Eye Sphere HPZ Vaious 886.3320 Fci Production Implant, Eye Sphere HPZ 886.3320 Gulden Ophthalmics Implant, Eye Sphere HPZ Silicone/also veterinary eye implants. 886.3320 Jardon Eye Prosthetics, Inc. Implant, Eye Sphere HPZ “mull sphere implant” (non-sterile). 886.3320 John J. Kelley Associates Ltd. Implant, Eye Sphere HPZ Various ocular implants Includes the NEW- 886.3320 Oculo Plastik Inc. ALLEN, UNIVERSAL, SILICONE and PMMA- SPHERES. Implant, Eye Sphere HPZ Eye sphere implant. 886.3320 W.L. Gore & Associates,Inc Implant, Absorbable (Scleral HQJ Various sizes of sterile and non-sterile 886.3300 Mira, Inc. Buckling Method) implants. Keratoprosthesis, Permanent HQM AlphaCor is a flexible, biotrgratable, one- 886.3400 Addition Technology, Inc. Implant piece artificial cornea (kertoprosthesis) designed to replace scarred or diseased native cornea. Keratoprosthesis, Permanent HQM Keratoprosthesis. 886.3400 M.E.E.I. Mfg. Implant Implant, Orbital, Extra-Ocular HQX Scleral buckles for retinal detachment 886.3340 Fci Ophthalmics surgery. Implant, Orbital, Extra-Ocular HQX Symblepharon ring 886.3340 Fci Production Implant, Orbital, Extra-Ocular HQX BIO-EYE Hydroxyapatite Orbital Implant for 886.3340 Integrated Orbital Implants, the anophthalmic patient. Inc. Implant, Orbital, Extra-Ocular HQX “winged sled” (non-sterile). 886.3340 John J. Kelley Associates Ltd. Implant, Orbital, Extra-Ocular HQX Eye implants. 886.3340 Mira, Inc. Implant, Orbital, Extra-Ocular HQX Codere-Durette, acrylic floor of the orbit. 886.3340 Oculo Plastik Inc. Also trianugular solid PTFE implamts. Plate, Fixation, Bone HRS Ubp system. 888.3030 Abbott Spine, Inc. Plate, Fixation, Bone HRS Single,multiple component bone fixation 888.3030 Acumed Llc appliance and accessories. Plate, Fixation, Bone HRS Plate, fixation, bone. 888.3030 Acute Innovations Llc Plate, Fixation, Bone HRS 4.5 compression plates. 888.3030 Alphatec Spine, Inc. Plate, Fixation, Bone HRS Bone plate. 888.3030 Arthrex, Inc. Plate, Fixation, Bone HRS Retrosternal strut.; MULTIPLE 888.3030 Biomet Microfixation Inc. Plate, Fixation, Bone HRS Poly-l-lactic acid/polyglycolic acid plates. 888.3030 Biomet, Inc. Plate, Fixation, Bone HRS Bone plates and screws. 888.3030 Bioplate, Inc. Plate, Fixation, Bone HRS Bone plate 888.3030 Bio-Prot, S.A. Plate, Fixation, Bone HRS Maxillofacial bone plate, fixation, bone. 888.3030 Bio-Technology Usa, Inc. Plate, Fixation, Bone HRS Natural-Knee HTO System. 888.3030 Centerpulse Orthopedics Inc. Plate, Fixation, Bone HRS Spinal plating system. 888.3030 Covidien Lp, Formerly Registered As United States Surgical Plate, Fixation, Bone HRS Ulnar, kienbock, radial plates & osteotomy 888.3030 Creative Medical Designs, devices. Inc. Plate, Fixation, Bone HRS Various 888.3030 Depuy Ace S.A.’R.L.

Source: MDRWeb.com 146 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Plate, Fixation, Bone HRS 888.3030 Depuy Ace, A Johnson & Johnson Company Plate, Fixation, Bone HRS Various 888.3030 Depuy France S.A. Plate, Fixation, Bone HRS Various types of bone fixation plates. 888.3030 Depuy Orthopaedics, Inc. Plate, Fixation, Bone HRS Bone plates. 888.3030 Depuy Spine, Inc. Plate, Fixation, Bone HRS Fixation system. 888.3030 Elekta, Inc. Plate, Fixation, Bone HRS Various types and sizes of bone fixation 888.3030 Gyrus Ent L.L.C., Sub. Of plates. Gyrus Acmi, Inc. Plate, Fixation, Bone HRS Distal volar radius fracture repair system 888.3030 Hand Innovations, Llc. (dvr). Plate, Fixation, Bone HRS Mini Titan Osteosynthese System. 888.3030 Hipp Gmbh, Anton Plate, Fixation, Bone HRS 888.3030 Holmed Corporation Plate, Fixation, Bone HRS Various bone plates. 888.3030 Integra Lifesciences Of Ohio Plate, Fixation, Bone HRS BONE; FIXATION; PLATE 888.3030 Kapp Surgical Instrument, Inc. Plate, Fixation, Bone HRS 888.3030 Keller Engineering, Inc. Plate, Fixation, Bone HRS 888.3030 Kls-Martin L.P. Plate, Fixation, Bone HRS 888.3030 Kmedic Plate, Fixation, Bone HRS ATLANTIS VISION ELITE Anterior Cervical Plate 888.3030 Medtronic, Inc. System Plate, Fixation, Bone HRS 888.3030 Merlyn Pharmaceuticals, Inc. Plate, Fixation, Bone HRS 888.3030 Onyx Medical Corp. Plate, Fixation, Bone HRS Orthopedic plates and screws. 888.3030 Orthohelix Surgical Designs, Inc. Plate, Fixation, Bone HRS Bone plate. 888.3030 Orthopedic Sciences, Inc Plate, Fixation, Bone HRS 888.3030 Pioneer Surgical Technology Plate, Fixation, Bone HRS SBI HAND FIXATION SYSTEM 888.3030 Small Bone Innovations, Inc. Plate, Fixation, Bone HRS Internal fixation system. 888.3030 Small Bone Innovations, Inc. Plate, Fixation, Bone HRS 888.3030 Smith & Nephew Inc.- Orthopaedics Division Plate, Fixation, Bone HRS Wafer system. 888.3030 Spine Wave, Inc. Plate, Fixation, Bone HRS Full line of titanium bone plates. Micro, mini, 888.3030 Striker Corp. low profile, fracture & reconstruction, etc. Plate, Fixation, Bone HRS 888.3030 Stryker Spine Plate, Fixation, Bone HRS Various types and sizes of bone plates. 888.3030 Synthes (Usa) Plate, Fixation, Bone HRS 888.3030 Synthes (Usa) - Brandywine Technical Center Plate, Fixation, Bone HRS 888.3030 Teufel Gmbh & Co. Kg Plate, Fixation, Bone HRS Bone plate devices. 888.3030 Warsaw Orthopedic, Inc. Plate, Fixation, Bone HRS 888.3030 Zimmer Holdings, Inc. Plate, Fixation, Bone HRS Various types and sizes of bone plates. 888.3030 Zimmer Manufacturing B.V. Plate, Fixation, Bone HRS Porous metal rod. 888.3030 Zimmer Trabecular Metal Technology Arthroscope HRX Arthroscopic irrigation sets 888.1100 Accellent El Paso Arthroscope HRX 1.9mm-5mm sizes available. Compatible to 888.1100 Advanced Endoscopy any manufacturer’s sheaths. Devices, Inc. Arthroscope HRX Various. 888.1100 Arthrex, Inc. Arthroscope HRX Endoscopic spine system. 888.1100 Arthro Kinetics Inc. Arthroscope HRX Various. 888.1100 Arthronet Medical, Inc. Arthroscope HRX Distractor. 888.1100 Arthroplastics, Inc. Arthroscope HRX Various 888.1100 Artscan Oy Arthroscope HRX Arthroscopic shavers and burs. 888.1100 Ascent Healthcare Solutions Arthroscope HRX Arthroscope 888.1100 Baho Innovative Medizintechnik Gmbh

Source: MDRWeb.com 147 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Arthroscope HRX Arthroscopic Irrigation Set; Cystoscopy 888.1100 Baxter Healthcare Irrigation Set; TUR Irrigation Set Corporation, Medication Delivery Arthroscope HRX Powertek ii with various accessories. 888.1100 Biomet Sports Medicine Arthroscope HRX Arthroscope. 888.1100 Biomet, Inc. Arthroscope HRX 2600 series, working channel endoscope. 888.1100 Clarus Medical, Llc. Arthroscope HRX 888.1100 ConMed Linvatec Arthroscope HRX Arthroscope. 888.1100 ConMed Linvatec Endoscopy Arthroscope HRX Manual Arthroscopic Instruments. 888.1100 Corin Group Limited Arthroscope HRX Orthopedics. 888.1100 Cortek Endoscopy, Inc. Arthroscope HRX Arthroscopic instruments. 888.1100 Covidien Lp, Formerly Registered As United States Surgical Arthroscope HRX Arthroscope and accessories. 888.1100 Davol Inc., Sub. C.R. Bard, Inc. Arthroscope HRX Suture bone fastener instrument set. 888.1100 Depuy Mitek, A Johnson & Johnson Company Arthroscope HRX Manual endoscopic instruments. 888.1100 Depuy Spine, Inc. Arthroscope HRX 888.1100 Dixon Medical Inc Arthroscope HRX Spinal endoscopic system. 888.1100 Ebi Patient Care, Inc. Arthroscope HRX Arthroscopes, instruments and lightsources. 888.1100 Efe Cons. & Imp. Ltda Surgical instruments; wound care vaccum assisted closure, binocular loupes... Arthroscope HRX Arthroscope devices 888.1100 Efinger Instruments Arthroscope HRX 888.1100 Gimmi Gmbh, Rudolf Arthroscope HRX Arthroscope. 888.1100 Global Endoscopy, Inc. Arthroscope HRX Arthroscope 888.1100 Groupe Efer Arthroscope HRX 888.1100 Henke Sass Wolf Of America, Inc. Arthroscope HRX Various 888.1100 Imtec Medizintechnik, Gmbh Arthroscope HRX 888.1100 Instratek, Inc. Arthroscope HRX 888.1100 Karl Storz Endoscopia Latino America Arthroscope HRX Full line of both diagnostic and operative 888.1100 Karl Storz Endoscopy- models in various sizes. America Inc. Arthroscope HRX OLYMPUS line. 888.1100 Keymed Medical & Industrial Equipment Ltd. Arthroscope HRX Various types of arthroscopic accessories 888.1100 Koscher & Wurtz Gmbh Arthroscope HRX 888.1100 Medicon Eg Arthroscope HRX Arthroscope. 888.1100 Medifix, Inc Arthroscope HRX Various arthroscopic & accessories, sterile. 888.1100 Medisiss Arthroscope HRX Independent service center specializing 888.1100 Medivision Endoscopy in rigid endoscope repairs and sales. Quality Control Department on premises. Provide customized maintenance reports to customers and distributors. Conduct technical training seminars and in-service programs. Manufa Arthroscope HRX Arthroscope and accessories. 888.1100 Medtec Applications, Inc. Arthroscope HRX 888.1100 Metasys Medizintechnik Gmbh Arthroscope HRX Arthroscope. 888.1100 Minrad, Inc. Arthroscope HRX Flexible arthroscope and accessories. 888.1100 Myelotec, Inc. Arthroscope HRX Various. 888.1100 Nuvasive, Inc. Arthroscope HRX 888.1100 O.R. Surgical Co., Inc. Arthroscope HRX 888.1100 Olympus America, Inc.

Source: MDRWeb.com 148 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Arthroscope HRX 888.1100 Olympus Winter & Ibe Gmbh Arthroscope HRX 888.1100 Precision Optics Corp. Arthroscope HRX Suture passer and cannulas. 888.1100 Regen Biologics, Inc. Arthroscope HRX From 2.7mm to 4mm in diameter, 888.1100 Rei Rotolux Enterprises, Inc. autoclavable. Custom configurations are available. Arthroscope HRX 888.1100 Rema Medizintechnik Gmbh Arthroscope HRX 888.1100 Richard Wolf Medical Instruments Corp. Arthroscope HRX 888.1100 Romc, Inc. Arthroscope HRX RX Honing Machines: System II sharpening 888.1100 Rx Honing Machine machine with surgical set #92701/11 Corporation easily maintains and restores arthroscopic instruments. Video and detailed manual included. Arthroscope HRX Arthroscope sheath 888.1100 Rz Medizintechnik Gmbh Arthroscope HRX Dyonics ep-1 shaver system. 888.1100 Smith & Nephew Inc., Endoscopy Div. Arthroscope HRX 888.1100 Smith & Nephew Plc. Arthroscope HRX 888.1100 Smith & Nephew, Inc., Endoscopy Division Arthroscope HRX 2 diagnostic models, 4.0mm diameter, 888.1100 Smith & Nephew, Inc., 76mm insertion length, rod-lens optics with Endoscopy Division 30deg. and 70deg. view or as 1.7mm diam., 55mm length, 15deg. model. Also available: arthroscopy accessories/powered surgical instruments. Arthroscope HRX Arthroscope and accessories. 888.1100 Solos Endoscopy Arthroscope HRX Arthroscopy instruments. 888.1100 Sterilmed, Inc. Arthroscope HRX Various 888.1100 Storz Endoskop Gmbh Arthroscope HRX 888.1100 Storz Gmbh & Co., Karl Arthroscope HRX 888.1100 Stryker Corp. Arthroscope HRX 888.1100 Stryker Endoscopy Arthroscope HRX 888.1100 Stryker Gmbh Arthroscope HRX Various. 888.1100 Stryker Instruments, Instruments Div. Arthroscope HRX 888.1100 Stryker Pacific Arthroscope HRX Various arthroscopic instruments. 888.1100 Stryker Puerto Rico, Ltd. Arthroscope HRX Orthopedic manual surgical instruments: 888.1100 Symmetry Tnco rasp, drills, graspers, scissors, punches. Arthroscope HRX Arhtroscope 888.1100 The Olympus Optical Co. Arthroscope HRX Arthroscope/orthopedic. 888.1100 Trans1 Incorporated Arthroscope HRX 888.1100 Trouamed Hengstler Gmbh Arthroscope HRX Arthroscopic instruments. 888.1100 Ussc Puerto Rico, Inc. Arthroscope HRX 888.1100 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Arthroscope HRX Arthroscopic pump 888.1100 W.O.M. World Of Medicine, Gmbh Arthroscope HRX Arthroscopic system. 888.1100 Warsaw Orthopedic, Inc. Arthroscope HRX 888.1100 Wisap America Arthroscope HRX No common name listed 888.1100 Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh Arthroscope HRX 888.1100 Wisap Gesellschaft Fur Wisseusch Apparatebau M.B.H. Arthroscope HRX FLEXPOSURE Endo-Retractor for increased 888.1100 Zimmer Spine visualization and access to the disc in endoscopic posterior spine procedures. Arthroscope HRX Laparoscopic spinal fusion instrumentation. 888.1100 Zimmer Spine, Inc.

Source: MDRWeb.com 149 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Knee, Femorotibial, Semi- HRY Various types of knee prosthesis. 888.3530 Biomet, Inc. Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, Semi- HRY Natural-Knee Unicompartmental System, 888.3530 Centerpulse Orthopedics Inc. Constrained, Cemented, Metal/ unicompartmental of the Natural-Knee Polymer system. Prosthesis, Knee, Femorotibial, Semi- HRY Various types of knee prostheses, semi- 888.3530 Depuy Orthopaedics, Inc. Constrained, Cemented, Metal/ constrained, cemented, metal/polymer. Polymer Prosthesis, Knee, Femorotibial, Semi- HRY Various types of knee prostheses, semi- 888.3530 Depuy-Raynham, A Div. Of Constrained, Cemented, Metal/ constrained, cemented, metal/polymer. Depuy Orthopaedics Polymer Prosthesis, Knee, Femorotibial, Semi- HRY CEMENTED, METAL/POLYMER - MAKO 888.3530 Mako Surgical Corp. Constrained, Cemented, Metal/ Modular Knee (MMK) System; Restoris MCK Polymer System; Restoris Multicompartmental Knee Sy Prosthesis, Knee, Femorotibial, Semi- HRY 888.3530 Smith & Nephew Inc.- Constrained, Cemented, Metal/ Orthopaedics Division Polymer Prosthesis, Knee, Femorotibial, Semi- HRY Various types of knees. 888.3530 Stryker Howmedica Constrained, Cemented, Metal/ Osteonics Polymer Prosthesis, Knee, Femorotibial, Semi- HRY 888.3530 Stryker Spine Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, Semi- HRY 888.3530 Zimmer Holdings, Inc. Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, Semi- HRY Various types and sizes of partially 888.3530 Zimmer Manufacturing B.V. Constrained, Cemented, Metal/ constrained total knee prostheses & Polymer accesso. Prosthesis, Knee, Femorotibial, Semi- HRY Various sterile femoral knee, tibial knee and 888.3530 Zimmer Trabecular Metal Constrained, Cemented, Metal/ patella knee. Technology Polymer Rod, Fixation, Intramedullary and HSB Ulna, radius, fibula rod. 888.3020 Acumed Llc Accessories Rod, Fixation, Intramedullary and HSB Intramedullary femoral nail. 888.3020 Advanced Orthopaedic Accessories Solutions, Inc. Rod, Fixation, Intramedullary and HSB Alphatec intramedallary nail system. 888.3020 Alphatec Spine, Inc. Accessories Rod, Fixation, Intramedullary and HSB Ender,kuntscher,rush,luque, harrington 888.3020 Baumer S.A. Accessories Rod, Fixation, Intramedullary and HSB Rod, fixation, intramedullary. 888.3020 Biomet Microfixation Inc. Accessories Rod, Fixation, Intramedullary and HSB Various sterile & non-sterile intramdullary 888.3020 Biomet, Inc. Accessories pins. Rod, Fixation, Intramedullary and HSB Wujin #3 Intramedullary Nail System 888.3020 Biopro, Inc. Accessories Rod, Fixation, Intramedullary and HSB Intramedullary rod 888.3020 Bio-Prot, S.A. Accessories Rod, Fixation, Intramedullary and HSB Various 888.3020 Depuy Ace S.A.’R.L. Accessories Rod, Fixation, Intramedullary and HSB Various 888.3020 Depuy France S.A. Accessories Rod, Fixation, Intramedullary and HSB Various. 888.3020 Depuy Orthopaedics, Inc. Accessories Rod, Fixation, Intramedullary and HSB Intramedullary fixation rod 888.3020 Disc-O-Tech Medical Accessories Technologies, Ltd. Rod, Fixation, Intramedullary and HSB Intramedullary fixation rod 888.3020 Intermedical Supplies Ltd. Accessories Rod, Fixation, Intramedullary and HSB Guidance system for placement of 888.3020 Modular Cutting Systems, Inc. Accessories intramedullary rod. Rod, Fixation, Intramedullary and HSB Unreamed tibial nail system 888.3020 Orthofix Srl Accessories

Source: MDRWeb.com 150 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Rod, Fixation, Intramedullary and HSB STAYFUSE (Interdigital fusion system), two 888.3020 Pioneer Surgical Technology Accessories piece AV titanium, intramedullary implant for fixation of small bone fusions and fractures. Most commonly used for the correction of Hammertoe deformities. Rod, Fixation, Intramedullary and HSB Intramedullary fixation rod. 888.3020 Small Bone Innovations, Inc. Accessories Rod, Fixation, Intramedullary and HSB 888.3020 Smith & Nephew Inc.- Accessories Orthopaedics Division Rod, Fixation, Intramedullary and HSB Various 888.3020 Smith & Nephew Accessories Orthopaedics, Gmbh Rod, Fixation, Intramedullary and HSB 888.3020 Stryker Spine Accessories Rod, Fixation, Intramedullary and HSB Various sizes of i.m. tibial nails.; MULTIPLE 888.3020 Surgical Implant Generation Accessories Network (Sign) Rod, Fixation, Intramedullary and HSB Various types of intramedullary rods. 888.3020 Warsaw Orthopedic, Inc. Accessories Rod, Fixation, Intramedullary and HSB 888.3020 Zimmer Holdings, Inc. Accessories Rod, Fixation, Intramedullary and HSB Various types and sizes of intramedullary 888.3020 Zimmer Manufacturing B.V. Accessories nails, pins, and sets containing vario. Prosthesis, Shoulder, Hemi-, Humeral, HSD Modular shoulder system. 888.3690 Acumed Llc Metallic Uncemented Prosthesis, Shoulder, Hemi-, Humeral, HSD Prosthesis,shoulder,hemi-,humeral,metallic 888.3690 Arthrex, Inc. Metallic Uncemented uncemented. Prosthesis, Shoulder, Hemi-, Humeral, HSD Shoulder joint humeral (hemi-shoulder) 888.3690 Arthrosurface, Inc. Metallic Uncemented metallic resurfacing prosthesis. Prosthesis, Shoulder, Hemi-, Humeral, HSD Ascension HRA 888.3690 Ascension Orthopedics, Inc. Metallic Uncemented Prosthesis, Shoulder, Hemi-, Humeral, HSD Various types of sterile and non-sterile 888.3690 Biomet, Inc. Metallic Uncemented shoulder prosthesis. Prosthesis, Shoulder, Hemi-, Humeral, HSD Various shoulder system components. 888.3690 Depuy Orthopaedics, Inc. Metallic Uncemented Prosthesis, Shoulder, Hemi-, Humeral, HSD Buechel-pappas humeral stem. 888.3690 Endotec, Inc. Metallic Uncemented Prosthesis, Shoulder, Hemi-, Humeral, HSD 888.3690 Smith & Nephew Inc.- Metallic Uncemented Orthopaedics Division Prosthesis, Shoulder, Hemi-, Humeral, HSD 888.3690 Stryker Spine Metallic Uncemented Prosthesis, Shoulder, Hemi-, Humeral, HSD 888.3690 Zimmer Holdings, Inc. Metallic Uncemented Prosthesis, Knee, Hemi-, Tibial HSH Knee interpositional arthroplasty device. 888.3590 Advanced Bio-Surfaces, Inc. Resurfacing, Uncemented Prosthesis, Knee, Hemi-, Tibial HSH Tibial knee. 888.3590 Bio-Technology Usa, Inc. Resurfacing, Uncemented Prosthesis, Knee, Hemi-, Tibial HSH Unispacer Knee System. 888.3590 Centerpulse Orthopedics Inc. Resurfacing, Uncemented Prosthesis, Knee, Hemi-, Tibial HSH Various types of knee prosthesis, hemi-tibial. 888.3590 Conformis, Inc. Resurfacing, Uncemented Prosthesis, Knee, Hemi-, Tibial HSH Interpositional spacer, fixed meniscus 888.3590 Salumedica, L.L.C. Resurfacing, Uncemented implant. Prosthesis, Knee, Hemi-, Tibial HSH 888.3590 Stryker Spine Resurfacing, Uncemented Prosthesis, Ankle, Semi-Constrained, HSN Various types. 888.3110 Depuy Orthopaedics, Inc. Cemented, Metal/Polymer Prosthesis, Ankle, Semi-Constrained, HSN Also ceramic. 888.3110 S&B Biomedics, Inc. Cemented, Metal/Polymer Prosthesis, Ankle, Semi-Constrained, HSN 888.3110 Stryker Spine Cemented, Metal/Polymer Prosthesis, Ankle, Semi-Constrained, HSN Ankle prosthesis. 888.3110 Topez Orthopedics, Inc Cemented, Metal/Polymer

Source: MDRWeb.com 151 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Ankle, Semi-Constrained, HSN 888.3110 Zimmer Holdings, Inc. Cemented, Metal/Polymer Prosthesis, Knee, Femorotibial, Non- HSX Stanmore total knee. 888.3520 Biomet, Inc. Constrained, Cemented, Metal/ polymer Prosthesis, Knee, Femorotibial, Non- HSX Unicondylar knee system. 888.3520 Conformis, Inc. Constrained, Cemented, Metal/ polymer Prosthesis, Knee, Femorotibial, Non- HSX Various types. 888.3520 Depuy Orthopaedics, Inc. Constrained, Cemented, Metal/ polymer Prosthesis, Knee, Femorotibial, Non- HSX Various types. 888.3520 Depuy-Raynham, A Div. Of Constrained, Cemented, Metal/ Depuy Orthopaedics polymer Prosthesis, Knee, Femorotibial, Non- HSX Various types of knees 888.3520 Howmedica International S. Constrained, Cemented, Metal/ De R.L., polymer Prosthesis, Knee, Femorotibial, Non- HSX CEMENTED, METAL/POLYMER - MAKO 888.3520 Mako Surgical Corp. Constrained, Cemented, Metal/ Unicondylar Knee System; Modular Knee polymer (MMK) System; Restoris MCK System; Restoris Multicompartmental Knee Sy Prosthesis, Knee, Femorotibial, Non- HSX OTI Condylar Knee System - standard total 888.3520 Osteoimplant Technology, Constrained, Cemented, Metal/ knee system available in five sizes. Inc. polymer Prosthesis, Knee, Femorotibial, Non- HSX 888.3520 Smith & Nephew Inc.- Constrained, Cemented, Metal/ Orthopaedics Division polymer Prosthesis, Knee, Femorotibial, Non- HSX Unicondylar knee system. 888.3520 Stelkast Company Constrained, Cemented, Metal/ polymer Prosthesis, Knee, Femorotibial, Non- HSX Various types of knees. 888.3520 Stryker Howmedica Constrained, Cemented, Metal/ Osteonics polymer Prosthesis, Knee, Femorotibial, Non- HSX 888.3520 Stryker Spine Constrained, Cemented, Metal/ polymer Prosthesis, Knee, Femorotibial, Non- HSX 888.3520 Zimmer Holdings, Inc. Constrained, Cemented, Metal/ polymer Prosthesis, Knee, Femorotibial, Non- HSX Continuum knee system (cks). 888.3520 Zimmer Trabecular Metal Constrained, Cemented, Metal/ Technology polymer Prosthesis, Knee, Hemi-, Patellar HTG 888.3580 Stryker Spine Resurfacing, Uncemented Washer, Bolt Nut HTN Washer. 888.3030 Arthrex Manufacturing Washer, Bolt Nut HTN Various types of washers. 888.3030 Arthrex, Inc. Washer, Bolt Nut HTN Various types of bolts, nuts, and washers. 888.3030 Biomet, Inc. Washer, Bolt Nut HTN Various 888.3030 Depuy Ace S.A.’R.L. Washer, Bolt Nut HTN Various 888.3030 Depuy France S.A. Washer, Bolt Nut HTN Various sizes of spiked washers. 888.3030 Depuy Mitek, A Johnson & Johnson Company Washer, Bolt Nut HTN Various types of washers, bolts, nuts. 888.3030 Depuy Orthopaedics, Inc. Washer, Bolt Nut HTN Washer, nut, bolt. 888.3030 Depuy Spine, Inc. Washer, Bolt Nut HTN Various types of washers, bolts, nuts. 888.3030 Depuy-Raynham, A Div. Of Depuy Orthopaedics Washer, Bolt Nut HTN Various models of washer, bolt, nut, 888.3030 Dimeda Instrumente Gmbh orthopedic Washer, Bolt Nut HTN 888.3030 DJO Inc. Washer, Bolt Nut HTN Washer. 888.3030 Interventional Spine, Inc. Washer, Bolt Nut HTN 316l washer. 888.3030 Koros Usa, Inc. Washer, Bolt Nut HTN 888.3030 Smith & Nephew Inc.- Orthopaedics Division

Source: MDRWeb.com 152 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Washer, Bolt Nut HTN Various bolts and nuts. 888.3030 Warsaw Orthopedic, Inc. Washer, Bolt Nut HTN 888.3030 Zimmer Holdings, Inc. Pin, Fixation, Smooth HTY Fixation pin. 888.3040 Acumed Llc Pin, Fixation, Smooth HTY Full line of pins and wires. 888.3040 American Medical Specialties, Inc. Pin, Fixation, Smooth HTY K-wire, pin. 888.3040 Arthrex Manufacturing Pin, Fixation, Smooth HTY Fixation pin. 888.3040 Arthrex, Inc. Pin, Fixation, Smooth HTY K-wire 888.3040 Beznoska S.R.O. Pin, Fixation, Smooth HTY Fixation pin or rod. 888.3040 Biomet, Inc. Pin, Fixation, Smooth HTY Smooth pin 888.3040 Bio-Prot, S.A. Pin, Fixation, Smooth HTY K-WIRE, STEINMAN pins. 888.3040 Brasseler Usa - Komet Medical Pin, Fixation, Smooth HTY Various. 888.3040 Brasseler Usa - Medical Pin, Fixation, Smooth HTY Fixator pins 888.3040 Depuy France S.A. Pin, Fixation, Smooth HTY Cross pins. 888.3040 Depuy Mitek, A Johnson & Johnson Company Pin, Fixation, Smooth HTY Various types of smooth fixation pins. 888.3040 Depuy Orthopaedics, Inc. Pin, Fixation, Smooth HTY Various types of smooth fixation pins. 888.3040 Depuy-Raynham, A Div. Of Depuy Orthopaedics Pin, Fixation, Smooth HTY Ceramic pins 888.3040 Gc Corp. Pin, Fixation, Smooth HTY Intramedullary fixation system for the hand. 888.3040 Hand Innovations, Llc. Pin, Fixation, Smooth HTY 888.3040 International Hospital Supply Co. Pin, Fixation, Smooth HTY Jurgan pin balls. 888.3040 Jurgan Development & Mfg., Ltd. Pin, Fixation, Smooth HTY 888.3040 Kmedic Pin, Fixation, Smooth HTY 888.3040 Onyx Medical Corp. Pin, Fixation, Smooth HTY $49.00 to $154.00 each for full line, original 888.3040 Rush-Berivon, Inc. Rush pin, Rush condyle. 1.6 to 8mm, length 3/4in to 21in. Pin, Fixation, Smooth HTY 888.3040 Simpex Medical, Inc. Pin, Fixation, Smooth HTY K-WIRES 888.3040 Small Bone Innovations, Inc. Pin, Fixation, Smooth HTY Smooth or threaded metallic bone fixation 888.3040 Small Bone Innovations, Inc. fastener. Pin, Fixation, Smooth HTY 888.3040 Smith & Nephew Inc.- Orthopaedics Division Pin, Fixation, Smooth HTY 888.3040 Stryker Spine Pin, Fixation, Smooth HTY Various types and sizes of smooth fixation 888.3040 Synthes (Usa) pins. Pin, Fixation, Smooth HTY K-Wires & Steinman Pins 888.3040 Tava Surgical Instruments Pin, Fixation, Smooth HTY 888.3040 Tegra Medical Inc. Pin, Fixation, Smooth HTY Various styles of steinmann pins and kirshner 888.3040 Warsaw Orthopedic, Inc. wires. Pin, Fixation, Smooth HTY Pin, capping device, external 888.3040 Westcon Orthopedics, Inc. Pin, Fixation, Smooth HTY 888.3040 Zimmer Holdings, Inc. Screw, Fixation, Bone HWC Ubp system. 888.3040 Abbott Spine, Inc. Screw, Fixation, Bone HWC Bone fixation screw, acutrak, acutrail plus, 888.3040 Acumed Llc extremity, fusion, mini acutrak. Screw, Fixation, Bone HWC Screw, fixation, bone. 888.3040 Acute Innovations Llc Screw, Fixation, Bone HWC Bone screws for orthopedic and cervical 888.3040 Aesculap Implant Systems fixation. Inc. Screw, Fixation, Bone HWC Cannulated cancellous bone screw & 888.3040 Alphatec Spine, Inc. cortical screws. Screw, Fixation, Bone HWC Multiple 888.3040 American Medical Systems, Inc.

Source: MDRWeb.com 153 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Screw, Fixation, Bone HWC Smooth or threaded metallic bone fixation 888.3040 Arc Surgical Llc. fastener. Screw, Fixation, Bone HWC Screw. 888.3040 Arthrex Manufacturing Screw, Fixation, Bone HWC Various. 888.3040 Arthrex, Inc. Screw, Fixation, Bone HWC Cannulated Screw System 888.3040 Ascension Orthopedics, Inc. Screw, Fixation, Bone HWC Various types of screws. 888.3040 Biomet Microfixation Inc. Screw, Fixation, Bone HWC Poly-l-lactic acid/polyglycolic acid screws. 888.3040 Biomet, Inc. Screw, Fixation, Bone HWC Bone screw 888.3040 Bio-Prot, S.A. Screw, Fixation, Bone HWC Maxillofacial screw fixation bone. 888.3040 Bio-Technology Usa, Inc. Screw, Fixation, Bone HWC Chin lift device and installation tools. 888.3040 Coapt Systems, Inc. Screw, Fixation, Bone HWC Same 888.3040 Combined Instruments (Pvt.), Ltd. Screw, Fixation, Bone HWC Micro-abrasive blasting equipment for 888.3040 Comco, Inc. deburring, cleaning, and surface prep of bone screws and other implant devices. Screw, Fixation, Bone HWC 888.3040 ConMed Linvatec Screw, Fixation, Bone HWC - Renovo; TAC-tite(TM) 888.3040 Core Essence Orthopaedics Inc. Screw, Fixation, Bone HWC Bone fixation. 888.3040 Covidien Lp, Formerly Registered As United States Surgical Screw, Fixation, Bone HWC Various 888.3040 Depuy Ace S.A.’R.L. Screw, Fixation, Bone HWC 888.3040 Depuy Ace, A Johnson & Johnson Company Screw, Fixation, Bone HWC Various 888.3040 Depuy France S.A. Screw, Fixation, Bone HWC Appliance for reconstruction of bone and 888.3040 Depuy Mitek, A Johnson & soft tissue. Johnson Company Screw, Fixation, Bone HWC Various types of bone fixation screws. 888.3040 Depuy Orthopaedics, Inc. Screw, Fixation, Bone HWC Bone screw. 888.3040 Depuy Spine, Inc. Screw, Fixation, Bone HWC Various types of bone fixation screws. 888.3040 Depuy-Raynham, A Div. Of Depuy Orthopaedics Screw, Fixation, Bone HWC Various models of screws fixation bone 888.3040 Dimeda Instrumente Gmbh Screw, Fixation, Bone HWC 888.3040 DJO Inc. Screw, Fixation, Bone HWC EMERGE MEDICAL CANNULATED SCREW 888.3040 Emerge Medical Inc. FIXATION SYSTEM Screw, Fixation, Bone HWC Buechel-pappas cancellous bone screw. 888.3040 Endotec, Inc. Screw, Fixation, Bone HWC Various types and sizes of bone fixation 888.3040 Gyrus Ent L.L.C., Sub. Of screws. Gyrus Acmi, Inc. Screw, Fixation, Bone HWC 888.3040 Holmed Corporation Screw, Fixation, Bone HWC Various 888.3040 Howmedica International S. De R.L., Screw, Fixation, Bone HWC Titanium cannulated bone-screw system. 888.3040 Instratek, Inc. Screw, Fixation, Bone HWC Various bone screws. 888.3040 Integra Lifesciences Of Ohio Screw, Fixation, Bone HWC Cannulated bone screw. 888.3040 Internal Fixation Systems, Inc. Screw, Fixation, Bone HWC Compression anchor system. 888.3040 Interventional Spine, Inc. Screw, Fixation, Bone HWC Various types of bone screws 888.3040 J.R.I. Mfg., Ltd. Screw, Fixation, Bone HWC 888.3040 Kls-Martin L.P. Screw, Fixation, Bone HWC 888.3040 Kmedic Screw, Fixation, Bone HWC Opti-Fiber; WedgeLoc; Morphix; WedgeLoc 888.3040 MedShape Solutions Inc. Screw, Fixation, Bone HWC Bone screw. 888.3040 Medtronic Sofamor Danek Usa, Inc. Screw, Fixation, Bone HWC 888.3040 Merlyn Pharmaceuticals, Inc. Screw, Fixation, Bone HWC 888.3040 Microcision Llc Screw, Fixation, Bone HWC Bone screw. 888.3040 Millennium Medical Technologies, Inc.

Source: MDRWeb.com 154 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Screw, Fixation, Bone HWC Cannulated screw. 888.3040 Orthohelix Surgical Designs, Inc. Screw, Fixation, Bone HWC 888.3040 Pioneer Surgical Technology Screw, Fixation, Bone HWC Interference screw. 888.3040 RTI Biologics Inc. Screw, Fixation, Bone HWC Screw, fixation, bone 888.3040 Rz Medizintechnik Gmbh Screw, Fixation, Bone HWC SI-BONE 888.3040 Si-Bone Inc. Screw, Fixation, Bone HWC Cancellous Bone screws. 888.3040 Signal Medical Corporation Screw, Fixation, Bone HWC Various bone fasteners. 888.3040 Simplicity Orthopedic Solutions, Llc Screw, Fixation, Bone HWC SBI HAND FIXATION SYSTEM 888.3040 Small Bone Innovations, Inc. Screw, Fixation, Bone HWC Internal fixation system. 888.3040 Small Bone Innovations, Inc. Screw, Fixation, Bone HWC 888.3040 Smith & Nephew Inc.- Orthopaedics Division Screw, Fixation, Bone HWC Various types of sterile and non-sterile bone 888.3040 Smith & Nephew fixation screw Orthopaedics, Gmbh Screw, Fixation, Bone HWC 888.3040 Smith & Nephew Plc. Screw, Fixation, Bone HWC ENDOFIX Absorbable interference surgical 888.3040 Smith & Nephew, Inc., fixation screw for bone-tendon-bone graft Endoscopy Division fixation in anterior cruciate ligament (ACL) surgery. Screw, Fixation, Bone HWC Full line of titanium bone screws. Micro, mini, 888.3040 Striker Corp. low profile, fracture & reconstruction, etc. Screw, Fixation, Bone HWC 888.3040 Stryker Spine Screw, Fixation, Bone HWC Fixation devices (bone screws and other 888.3040 Supreme Screw Products, components). Inc. Screw, Fixation, Bone HWC Various types and sizes of bone fixation 888.3040 Synthes (Usa) screws. Screw, Fixation, Bone HWC 888.3040 Synthes (Usa) - Brandywine Technical Center Screw, Fixation, Bone HWC 888.3040 Theken Spine Llc Screw, Fixation, Bone HWC Bone achor. 888.3040 Tornier Inc. Screw, Fixation, Bone HWC Bone fixation. 888.3040 Ussc Puerto Rico, Inc. Screw, Fixation, Bone HWC Bone screws-sterile and non-sterile. 888.3040 Warsaw Orthopedic, Inc. Screw, Fixation, Bone HWC Also, compression hip screw. 888.3040 Zimmer Holdings, Inc. Screw, Fixation, Bone HWC Various types and sizes of bones screws. 888.3040 Zimmer Manufacturing B.V. Screw, Fixation, Bone HWC Sterile cancellous bone screws and non- 888.3040 Zimmer Trabecular Metal sterile instruments. Technology Screw, Fixation, Bone HWC Ti Bone Screw, Corifix Ligament Anchor, 888.3040 Corin Group Limited Stainless Corticl Screws, 6.5mm Stainless Cancellous Screws (short thread & long thread). Prosthesis, Facial, Mandibular JAZ Various types of prothesis. 874.3695 Biomet Microfixation Inc. Implant Prosthesis, Facial, Mandibular JAZ Hard tissue replacement (htr) granular. 874.3695 Biomet, Inc. Implant Prosthesis, Facial, Mandibular JAZ Various sizes of mandibular implants 874.3695 Genetis S.A. Implant Prosthesis, Facial, Mandibular JAZ Flowers Mandibular Glove, MITTLEMAN Pre 874.3695 Implantech Associates, Inc. Implant jowl chin, MITTLEMAN Prejowel. Prosthesis, Facial, Mandibular JAZ Noses, ears, and orbitals. 874.3695 Life-Like Laboratory Implant Prosthesis, Facial, Mandibular JAZ Intra-oral double mouthgard to end bruxing 874.3695 Tmj Appliance Implant and repair temporomandibular-joint damage. Prosthesis, Esophagus JCQ Esophageal tube with 15mm O.D. 878.3610 E. Benson Hood Laboratories, Inc. Prosthesis, Esophagus JCQ Bonastent Esophageal by Sewoon; 878.3610 Endochoice Inc. Bonastent Esophageal design SST; Bonastent Esophageal mfg by Sewoon; EndoChoice Bonastent Esophageal

Source: MDRWeb.com 155 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Esophagus JCQ 878.3610 Porges S.A. Prosthesis, Tracheal, Expandable JCT 878.3720 Boston Medical Products, Inc. Prosthesis, Tracheal, Expandable JCT 878.3720 Boston Scientific Corp. Prosthesis, Tracheal, Expandable JCT Tracheobronchial stent 878.3720 Boston Scientific Ireland, Ltd. Prosthesis, Tracheal, Expandable JCT Tracheal prothesis. 878.3720 Cook Endoscopy Prosthesis, Tracheal, Expandable JCT T-Tubes with 4.5-16mm (standard), 878.3720 E. Benson Hood Laboratories, 5-18mm (long) 8-14mm (thoracic) outer Inc. diameters, T-Y Tubes with 10, 12, and 14mm OD. Tracheal stent with post. Ultra-smooth surface treatment. Prosthesis, Tracheal, Expandable JCT Tracheobronchial stent. 878.3720 Ev3 Inc. Prosthesis, Tracheal, Expandable JCT Tracheobronchial stents 878.3720 Novatech S.A. Prosthesis, Tracheal, Expandable JCT Esopageal & tracheal endoprosthesis. 878.3720 W.L. Gore & Associates,Inc Prosthesis, Elbow, Semi-Constrained, JDB Various types of sterile and non-sterile total 888.3160 Biomet, Inc. Cemented elbows. Prosthesis, Elbow, Semi-Constrained, JDB Various types of semi-constrained, 888.3160 Depuy Orthopaedics, Inc. Cemented cemented, elbow prostheses. Prosthesis, Elbow, Semi-Constrained, JDB Various types of semi-constrained, 888.3160 Depuy-Raynham, A Div. Of Cemented cemented, elbow prostheses. Depuy Orthopaedics Prosthesis, Elbow, Semi-Constrained, JDB CEMENTED - SBI RADIO CAPITELLUM 888.3160 Small Bone Innovations, Inc. Cemented Prosthesis, Elbow, Semi-Constrained, JDB Elbow joint metal/polymer semi-constrained 888.3160 Small Bone Innovations, Inc. Cemented cemented prosthesis. Prosthesis, Elbow, Semi-Constrained, JDB 888.3160 Smith & Nephew Inc.- Cemented Orthopaedics Division Prosthesis, Elbow, Semi-Constrained, JDB 888.3160 Stryker Spine Cemented Prosthesis, Elbow, Semi-Constrained, JDB 888.3160 Zimmer Holdings, Inc. Cemented Prosthesis, Elbow, Constrained, JDC Various types of sterile & non-sterile elbow 888.3150 Biomet, Inc. Cemented components. Prosthesis, Elbow, Constrained, JDC GSB Elbow cemented contrained elbow. 888.3150 Centerpulse Orthopedics Inc. Cemented Prosthesis, Elbow, Constrained, JDC Various types of elbow prostheses, 888.3150 Depuy Orthopaedics, Inc. Cemented constrained, cemented. Prosthesis, Elbow, Constrained, JDC 888.3150 Zimmer Holdings, Inc. Cemented Prosthesis, Upper Femoral JDD Various types of femoral hip prosthesis. 888.3360 Biomet, Inc. Prosthesis, Upper Femoral JDD 888.3360 Smith & Nephew Inc.- Orthopaedics Division Prosthesis, Upper Femoral JDD 888.3360 Stryker Spine Prosthesis, Upper Femoral JDD Thompson and moore type hip prostheses. 888.3360 Warsaw Orthopedic, Inc. Prosthesis, Upper Femoral JDD 888.3360 Zimmer Holdings, Inc. Prosthesis, Hip, Femoral Component, JDG Various types of femoral total hip prosthesis. 888.3360 Biomet, Inc. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG Bio-technology usa hip stem. 888.3360 Bio-Technology Usa, Inc. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG FracSure System. 888.3360 Centerpulse Orthopedics Inc. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG CTi Straight Stem, Thompson Hip (titanium & 888.3360 Corin Group Limited Cemented, Metal cobalt chrome). Prosthesis, Hip, Femoral Component, JDG Femoral hip prostheses 888.3360 Depuy France S.A. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG Various types of femoral hip prosthesis 888.3360 Depuy Orthopaedics, Inc. Cemented, Metal components. Prosthesis, Hip, Femoral Component, JDG Various types of femoral hip prosthesis 888.3360 Depuy-Raynham, A Div. Of Cemented, Metal components. Depuy Orthopaedics Prosthesis, Hip, Femoral Component, JDG Buechel-pappas modular femoral stem. 888.3360 Endotec, Inc. Cemented, Metal

Source: MDRWeb.com 156 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Femoral Component, JDG AcuMatch C-Series. 888.3360 Exactech, Inc. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG 888.3360 Foster Manufacturing Corp. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG Cement plugs and cement 888.3360 J.R.I. Mfg., Ltd. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG FURLONG. 888.3360 Joint Replacement Cemented, Metal Instrumentation Ltd. Prosthesis, Hip, Femoral Component, JDG Thompson. 888.3360 Medtronic Sofamor Danek Cemented, Metal Usa, Inc. Prosthesis, Hip, Femoral Component, JDG 888.3360 Orchid Stealth Orthopedic Cemented, Metal Solutions Prosthesis, Hip, Femoral Component, JDG 888.3360 Smith & Nephew Inc.- Cemented, Metal Orthopaedics Division Prosthesis, Hip, Femoral Component, JDG Artificial hip replacement system. 888.3360 Stelkast Company Cemented, Metal Prosthesis, Hip, Femoral Component, JDG Thompson. 888.3360 Warsaw Orthopedic, Inc. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG 888.3360 Zimmer Holdings, Inc. Cemented, Metal Prosthesis, Hip, Femoral Component, JDG Hip joint femoral(hemi-hip) metallic 888.3360 Zimmer Manufacturing B.V. Cemented, Metal cemented or uncemented prosthesis. Prosthesis, Hip, Semi-Constrained, JDI Various types of hip, modular heads, 888.3350 Biomet, Inc. Metal/Polymer, Cemented andacetabular prosthesis. Prosthesis, Hip, Semi-Constrained, JDI Apollo hip system, All-poly acetabular 888.3350 Centerpulse Orthopedics Inc. Metal/Polymer, Cemented cup, full and low profile all-poly cups and reinforced rings and cage. Prosthesis, Hip, Semi-Constrained, JDI 888.3350 Corin Group Limited Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI Total hip prosthesis 888.3350 Depuy France S.A. Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI Various types of semi-constrained, metal/ 888.3350 Depuy Orthopaedics, Inc. Metal/Polymer, Cemented polymer, cemented hip prostheses. Prosthesis, Hip, Semi-Constrained, JDI Various types of semi-constrained, metal/ 888.3350 Depuy-Raynham, A Div. Of Metal/Polymer, Cemented polymer, cemented hip prostheses. Depuy Orthopaedics Prosthesis, Hip, Semi-Constrained, JDI Prosthesis, Hip, Total. Unisyn complete 888.3350 Hayes Medical, Inc. Metal/Polymer, Cemented hip system; modular; porous acetabular components; bipolar mode. Prosthesis, Hip, Semi-Constrained, JDI Multi purpose hip endprosthesis stem 888.3350 Hipokrat Tibbi Malzemeler Metal/Polymer, Cemented Imalat Ve Pazarlama A.S Prosthesis, Hip, Semi-Constrained, JDI Various types of hips 888.3350 Howmedica International S. Metal/Polymer, Cemented De R.L., Prosthesis, Hip, Semi-Constrained, JDI 888.3350 Implex Corp. Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI LOL. 127 Cemented with modular bi-polar 888.3350 Joint Replacement Metal/Polymer, Cemented femoral head. Instrumentation Ltd. Prosthesis, Hip, Semi-Constrained, JDI Cement restrictor. 888.3350 Macropore Biosurgery, Inc. Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI 888.3350 Smith & Nephew Inc.- Metal/Polymer, Cemented Orthopaedics Division Prosthesis, Hip, Semi-Constrained, JDI Artificial hip replacement components. 888.3350 Stelkast Company Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI Various types of hips. 888.3350 Stryker Howmedica Metal/Polymer, Cemented Osteonics Prosthesis, Hip, Semi-Constrained, JDI 888.3350 Stryker Spine Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI Ultra high molecular weight polyethylene 888.3350 Warsaw Orthopedic, Inc. Metal/Polymer, Cemented cup. Prosthesis, Hip, Semi-Constrained, JDI 888.3350 Zimmer Holdings, Inc. Metal/Polymer, Cemented Prosthesis, Hip, Semi-Constrained, JDI Various types and sizesof sterile acetabular 888.3350 Zimmer Manufacturing B.V. Metal/Polymer, Cemented cups and shells.

Source: MDRWeb.com 157 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Semi-Constrained, JDI Hep revision cup hedrocel. 888.3350 Zimmer Trabecular Metal Metal/Polymer, Cemented Technology Prosthesis, Hip, Acetabular Mesh JDJ Various types. 878.3300 Bio-Technology Usa, Inc. Prosthesis, Hip, Acetabular Mesh JDJ Prosthesis, hip, acetabular mesh (various 878.3300 Depuy Orthopaedics, Inc. types). Prosthesis, Hip, Acetabular Mesh JDJ 878.3300 Smith & Nephew Inc.- Orthopaedics Division Prosthesis, Hip, Acetabular Mesh JDJ Cobalt-chromium-molybdenum alloy. 878.3300 Stryker Spine Prosthesis, Hip, Acetabular Mesh JDJ 878.3300 Zimmer Holdings, Inc. Prosthesis, Hip, Acetabular Mesh JDJ Acetabular reconstructive mesh. 878.3300 Zimmer Manufacturing B.V. Prosthesis, Hip, Cement Restrictor JDK Cement restrictor. 878.3300 Abbott Spine, Inc. Prosthesis, Hip, Cement Restrictor JDK Cement restrictor. 878.3300 Biomet, Inc. Prosthesis, Hip, Cement Restrictor JDK Bio-technology spoac centralizer, hip. 878.3300 Bio-Technology Usa, Inc. Prosthesis, Hip, Cement Restrictor JDK Hardinge Canal Occluder 878.3300 Corin Group Limited Prosthesis, Hip, Cement Restrictor JDK Bone cement restrictor 878.3300 Depuy Bioland Prosthesis, Hip, Cement Restrictor JDK Cement restrictor 878.3300 Depuy France S.A. Prosthesis, Hip, Cement Restrictor JDK Various types of hip prosthesis cement 878.3300 Depuy Orthopaedics, Inc. restrictors. Prosthesis, Hip, Cement Restrictor JDK Prosthesis, hip, cement restrictor (various 878.3300 Depuy-Raynham, A Div. Of types). Depuy Orthopaedics Prosthesis, Hip, Cement Restrictor JDK Cement restrictor, sterile 878.3300 European Medical Contract Mfg. Prosthesis, Hip, Cement Restrictor JDK Disposable scissors 878.3300 Hongyan Knives & Scissors Technological Factory Of Prosthesis, Hip, Cement Restrictor JDK Cement restrictor implant system for use in 878.3300 Innovasis, Inc. orthopedic surgery. Prosthesis, Hip, Cement Restrictor JDK Cement restrictor. 878.3300 Medtronic Sofamor Danek Usa, Inc. Prosthesis, Hip, Cement Restrictor JDK Cement restrictor. 878.3300 Nuvasive, Inc. Prosthesis, Hip, Cement Restrictor JDK Sterile cement restrictor 878.3300 Signus Medizintechnik Gmbh Prosthesis, Hip, Cement Restrictor JDK 878.3300 Smith & Nephew Inc.- Orthopaedics Division Prosthesis, Hip, Cement Restrictor JDK Various cement restrictors. 878.3300 Spinal Elements, Inc. Prosthesis, Hip, Cement Restrictor JDK Various types of sterile cement restrictors. 878.3300 Stryker Instruments, Instruments Div. Prosthesis, Hip, Cement Restrictor JDK Various types of sterile cement restrictors. 878.3300 Stryker Puerto Rico, Ltd. Prosthesis, Hip, Cement Restrictor JDK 878.3300 Stryker Spine Prosthesis, Hip, Cement Restrictor JDK 878.3300 Theken Spine Llc Prosthesis, Hip, Cement Restrictor JDK Cement restrictor. 878.3300 Warsaw Orthopedic, Inc. Prosthesis, Hip, Cement Restrictor JDK OTI Bone Cement Plug (Varilift Cage) 878.3300 Wenzel Spine Inc. Prosthesis, Hip, Cement Restrictor JDK 878.3300 Zimmer Holdings, Inc. Prosthesis, Hip, Cement Restrictor JDK Restrictor. 878.3300 Zimmer Trabecular Metal Technology Implant, Fixation Device, Spinal JDN Various. 888.3060 Advanced Spine Technology, Inc. Implant, Fixation Device, Spinal JDN Meurig williams plate. 888.3060 Biomet, Inc. Implant, Fixation Device, Spinal JDN 888.3060 Bolt Bethel, Llc Implant, Fixation Device, Spinal JDN Various spinal hooks, rods, couplers, wires 888.3060 Depuy Spine, Inc. and related instrument. Implant, Fixation Device, Spinal JDN Interlaminar clamps. 888.3060 Depuy-Raynham, A Div. Of Depuy Orthopaedics Implant, Fixation Device, Spinal JDN 888.3060 Holmed Corporation Implant, Fixation Device, Spinal JDN RENEW Interspinous Allograft Technology 888.3060 Interventional Spine, Inc. Implant, Fixation Device, Spinal JDN 888.3060 Kapp Surgical Instrument, Inc.

Source: MDRWeb.com 158 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Implant, Fixation Device, Spinal JDN “Smart” implant with MEMS devices 888.3060 Life Medical Llc incorporated into the implant that communicate position, motion, pressure, load, and strain. Implant, Fixation Device, Spinal JDN 888.3060 Microcision Llc Implant, Fixation Device, Spinal JDN Intervertebral disc. 888.3060 Micron Precision Engineering, Inc. Implant, Fixation Device, Spinal JDN Multiple and various. 888.3060 Millstone Medical Outsourcing Implant, Fixation Device, Spinal JDN 888.3060 Pioneer Surgical Technology Implant, Fixation Device, Spinal JDN Spinal Orthopedic Implants. 888.3060 Rickman Tool, Inc. Implant, Fixation Device, Spinal JDN J.B.S. Spine System, Grobal Stabilization 888.3060 Showa Ika Kogyo Co. Ltd. System and Sutter C.P.M. Implant, Fixation Device, Spinal JDN 888.3060 V--Operations Management Consulting, Implant, Fixation Device, Spinal JDN Various inplant fixation devices, spinal - 888.3060 Warsaw Orthopedic, Inc. sterile and non-sterile. Implant, Fixation Device, Spinal JDN Various types and sizes of spinal fixation 888.3060 Zimmer Manufacturing B.V. devices and accessories. Device, Fixation, Proximal Femoral, JDO 888.3030 Benoist Girard Implant Device, Fixation, Proximal Femoral, JDO Various types of proximal femoral fixation 888.3030 Biomet, Inc. Implant devices. Device, Fixation, Proximal Femoral, JDO Gotfried pc. c.p. 888.3030 Efratgo, Ltd. Hi Tech Bio- Implant Surgical Device, Fixation, Proximal Femoral, JDO 888.3030 Keller Engineering, Inc. Implant Device, Fixation, Proximal Femoral, JDO 888.3030 Kinetikos Medical, Inc. Implant Device, Fixation, Proximal Femoral, JDO 888.3030 Kmedic Implant Device, Fixation, Proximal Femoral, JDO Orthopedic implants 888.3030 LinkBio Corp. Implant Device, Fixation, Proximal Femoral, JDO Multiple (proximal femoral fixation devices, 888.3030 Medtronic Puerto Rico Implant nails, plates, screws, pins). Operations Co.,Med Rel Device, Fixation, Proximal Femoral, JDO Multiple (proximal femoral fixation devices, 888.3030 Medtronic Sofamor Danek Implant nails, plates, screws, pins). Usa, Inc. Device, Fixation, Proximal Femoral, JDO 888.3030 Orchid Macdee Inc. Implant Device, Fixation, Proximal Femoral, JDO 888.3030 Smith & Nephew Inc.- Implant Orthopaedics Division Device, Fixation, Proximal Femoral, JDO Various 888.3030 Smith & Nephew Implant Orthopaedics, Gmbh Device, Fixation, Proximal Femoral, JDO 888.3030 Stryker Spine Implant Device, Fixation, Proximal Femoral, JDO Various types and sizes of proximal femur 888.3030 Synthes (Usa) Implant fixation devices. Device, Fixation, Proximal Femoral, JDO Multiple (proximal femoral fixation devices, 888.3030 Warsaw Orthopedic, Inc. Implant nails, plates, screws, pins). Device, Fixation, Proximal Femoral, JDO Various types and sizes of proximal femoral 888.3030 Zimmer Manufacturing B.V. Implant fixation devices. Condylar Plate Fixation Implant JDP Condylar fixation device. 888.3030 Biomet Microfixation Inc. Condylar Plate Fixation Implant JDP Various types of condylar blade plates. 888.3030 Biomet, Inc. Condylar Plate Fixation Implant JDP Contract manufacturing: trauma, 888.3030 C.O.R.E. Tech, Inc. spinal, and reconstructive implants and instrumentation. Condylar Plate Fixation Implant JDP 888.3030 Kmedic Condylar Plate Fixation Implant JDP Dr maudhuit blade plate 888.3030 Medicalex Condylar Plate Fixation Implant JDP 888.3030 Panadent Corp.

Source: MDRWeb.com 159 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Condylar Plate Fixation Implant JDP 888.3030 Smith & Nephew Inc.- Orthopaedics Division Condylar Plate Fixation Implant JDP Various types and sizes of condylar plate 888.3030 Synthes (Usa) fixation devices. Condylar Plate Fixation Implant JDP 888.3030 Zimmer Holdings, Inc. Cerclage, Fixation JDQ Metallic bone fixaton appliance or cable. 888.3010 Abbott Spine, Inc. Cerclage, Fixation JDQ Cerlage,fixation (wire & cable). 888.3010 Acumed Llc Cerclage, Fixation JDQ Cerclage kit for orthopedic uses. 888.3010 Arthrex, Inc. Cerclage, Fixation JDQ Parham band. 888.3010 Biomet, Inc. Cerclage, Fixation JDQ Orthopedic polyethlyene cable. 888.3010 Covidien Lp, Formerly Registered As United States Surgical Cerclage, Fixation JDQ Various 888.3010 Howmedica International S. De R.L., Cerclage, Fixation JDQ 888.3010 Pioneer Surgical Technology Cerclage, Fixation JDQ 888.3010 Smith & Nephew Inc.- Orthopaedics Division Cerclage, Fixation JDQ 888.3010 Stryker Spine Cerclage, Fixation JDQ Various types and sizes of cerclage wires. 888.3010 Synthes (Usa) Cerclage, Fixation JDQ Cable devices-sterile and non-sterile. 888.3010 Warsaw Orthopedic, Inc. Cerclage, Fixation JDQ 888.3010 Zimmer Holdings, Inc. Staple, Fixation, Bone JDR Suture anchor. 888.3030 Acumed Llc Staple, Fixation, Bone JDR Bone staple. 888.3030 Arthrex, Inc. Staple, Fixation, Bone JDR OSStaple/OSSplate, shape memory nitinol 888.3030 Biomedical Enterprises, Inc. staples and accessories for setting and warming the staples with the OSSforce to achieve fracture, osteotomy or arthrodesis compression. Staple, Fixation, Bone JDR Meniscal staple. 888.3030 Biomet, Inc. Staple, Fixation, Bone JDR Reverto; MULTIPLE 888.3030 Core Essence Orthopaedics Inc. Staple, Fixation, Bone JDR Bone fixators. 888.3030 Covidien Lp, Formerly Registered As United States Surgical Staple, Fixation, Bone JDR Appliance for reconstruction of bone and 888.3030 Depuy Mitek, A Johnson & soft tissue. Johnson Company Staple, Fixation, Bone JDR Various types of bone fixation staples. 888.3030 Depuy Orthopaedics, Inc. Staple, Fixation, Bone JDR Various types of bone fixation staples. 888.3030 Depuy-Raynham, A Div. Of Depuy Orthopaedics Staple, Fixation, Bone JDR Various models of staples,fixation, bone 888.3030 Dimeda Instrumente Gmbh Staple, Fixation, Bone JDR 888.3030 Holmed Corporation Staple, Fixation, Bone JDR Various 888.3030 Howmedica International S. De R.L., Staple, Fixation, Bone JDR 888.3030 Innovasive Devices, Inc. Staple, Fixation, Bone JDR Staple, fixation, bone. 888.3030 Intelifuse, Inc. Staple, Fixation, Bone JDR 888.3030 International Hospital Supply Co. Staple, Fixation, Bone JDR Staple 888.3030 Michael’s France Staple, Fixation, Bone JDR Multiple 888.3030 S.P.O.R.T. Staple, Fixation, Bone JDR 888.3030 Smith & Nephew Inc.- Orthopaedics Division Staple, Fixation, Bone JDR 888.3030 Smith & Nephew, Inc., Endoscopy Division Staple, Fixation, Bone JDR 888.3030 Stryker Spine Staple, Fixation, Bone JDR Fastlok 888.3030 Tapco Medical, Inc. Staple, Fixation, Bone JDR Staple, fixation, bone 888.3030 Trade Coop Trading House Ltd.

Source: MDRWeb.com 160 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Staple, Fixation, Bone JDR Various. 888.3030 Ussc Puerto Rico, Inc. Staple, Fixation, Bone JDR 888.3030 V--Operations Management Consulting, Staple, Fixation, Bone JDR Staple. 888.3030 Warsaw Orthopedic, Inc. Staple, Fixation, Bone JDR Cradle fixation device 888.3030 Xiros Plc Staple, Fixation, Bone JDR 888.3030 Zimmer Holdings, Inc. Nail, Fixation, Bone JDS Compression hip screw. 888.3030 Alphatec Spine, Inc. Nail, Fixation, Bone JDS Various 888.3030 Depuy Ace S.A.’R.L. Nail, Fixation, Bone JDS 888.3030 Depuy Ace, A Johnson & Johnson Company Nail, Fixation, Bone JDS Various 888.3030 Depuy France S.A. Nail, Fixation, Bone JDS Various types of bone fixation nails. 888.3030 Depuy Orthopaedics, Inc. Nail, Fixation, Bone JDS Bone nail. 888.3030 Depuy Spine, Inc. Nail, Fixation, Bone JDS Various types of bone fixation nails. 888.3030 Depuy-Raynham, A Div. Of Depuy Orthopaedics Nail, Fixation, Bone JDS Various models of nails,fixation,bone 888.3030 Dimeda Instrumente Gmbh Nail, Fixation, Bone JDS 888.3030 International Hospital Supply Co. Nail, Fixation, Bone JDS 888.3030 Keller Engineering, Inc. Nail, Fixation, Bone JDS 888.3030 Onyx Medical Corp. Nail, Fixation, Bone JDS 888.3030 Paramedical Distributors Nail, Fixation, Bone JDS No common name listed 888.3030 Schad Medical Instruments Gmbh Nail, Fixation, Bone JDS 888.3030 Smith & Nephew Inc.- Orthopaedics Division Nail, Fixation, Bone JDS 888.3030 Smith & Nephew Plc. Nail, Fixation, Bone JDS Various 888.3030 Stille Surgical Ab Nail, Fixation, Bone JDS 888.3030 Stryker Spine Nail, Fixation, Bone JDS 888.3030 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Nail, Fixation, Bone JDS 888.3030 Zimmer Holdings, Inc. Nail, Fixation, Bone JDS Various types and sizes of sliding and non- 888.3030 Zimmer Manufacturing B.V. sliding bone nails & nail/plate combi. Pin, Fixation, Threaded JDW External fixation devive with threaded 888.3040 Acumed Llc threaded fixation pins. Pin, Fixation, Threaded JDW Alphatec external fixation hybrid system. 888.3040 Alphatec Spine, Inc. Pin, Fixation, Threaded JDW Full line of pins and wires. 888.3040 American Medical Specialties, Inc. Pin, Fixation, Threaded JDW Various types of threaded pins. 888.3040 Biomet, Inc. Pin, Fixation, Threaded JDW Threaded pins 888.3040 Bio-Prot, S.A. Pin, Fixation, Threaded JDW 888.3040 Brasseler Usa - Komet Medical Pin, Fixation, Threaded JDW Various 888.3040 Brasseler Usa - Medical Pin, Fixation, Threaded JDW Various 888.3040 Depuy Ace S.A.’R.L. Pin, Fixation, Threaded JDW 888.3040 Depuy Ace, A Johnson & Johnson Company Pin, Fixation, Threaded JDW Various 888.3040 Depuy France S.A. Pin, Fixation, Threaded JDW Cross pins. 888.3040 Depuy Mitek, A Johnson & Johnson Company Pin, Fixation, Threaded JDW Various types of threaded fixation pins. 888.3040 Depuy Orthopaedics, Inc. Pin, Fixation, Threaded JDW Various types of threaded fixation pins. 888.3040 Depuy-Raynham, A Div. Of Depuy Orthopaedics Pin, Fixation, Threaded JDW 888.3040 DJO Inc. Pin, Fixation, Threaded JDW Bone fixation system 888.3040 Intermedical Supplies Ltd. Pin, Fixation, Threaded JDW 888.3040 Kmedic

Source: MDRWeb.com 161 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pin, Fixation, Threaded JDW 888.3040 Microcision Llc Pin, Fixation, Threaded JDW Distraction pin. 888.3040 New Business Development, Llc Pin, Fixation, Threaded JDW Various types of pins, fixation, threaded 888.3040 Normed Gmbh Pin, Fixation, Threaded JDW 888.3040 Onyx Medical Corp. Pin, Fixation, Threaded JDW Dynamic axial fixation system 888.3040 Orthofix Srl Pin, Fixation, Threaded JDW Kirshner wires (k-wire) & steinmann pins. 888.3040 Promex Technologies, Llc Pin, Fixation, Threaded JDW Smooth or threaded metallic bone fixation. 888.3040 R&R Medical, Inc. Pin, Fixation, Threaded JDW 888.3040 Simpex Medical, Inc. Pin, Fixation, Threaded JDW 888.3040 Smith & Nephew Inc.- Orthopaedics Division Pin, Fixation, Threaded JDW 888.3040 Stryker Spine Pin, Fixation, Threaded JDW Various types and sizes of smooth fixation 888.3040 Synthes (Usa) pins. Pin, Fixation, Threaded JDW Various. 888.3040 Tava Surgical Instruments Pin, Fixation, Threaded JDW 888.3040 Tegra Medical Inc. Pin, Fixation, Threaded JDW 888.3040 Vilex, Inc. Pin, Fixation, Threaded JDW Various styles of threaded steinmann pins 888.3040 Warsaw Orthopedic, Inc. and kirshner wires. Pin, Fixation, Threaded JDW Pin, capping device, external. 888.3040 Westcon Orthopedics, Inc. Pin, Fixation, Threaded JDW 888.3040 Zimmer Holdings, Inc. Instrument, Surgical, Sonic and JDX Sonic, orthopedic surgical instrument 888.4580 Biomet Sports Medicine Acessory/attachment system. Instrument, Surgical, Sonic and JDX Various types of ultrasonic bone cutting 888.4580 Biomet, Inc. Acessory/attachment instruments. Instrument, Surgical, Sonic and JDX 888.4580 Vitalaire Gmbh Acessory/attachment Component, Traction, Invasive JEC Small bone fixator. 888.3040 Acumed Llc Component, Traction, Invasive JEC External fixation device. 888.3040 Ascent Healthcare Solutions Component, Traction, Invasive JEC 888.3040 Autogenesis, Inc. Component, Traction, Invasive JEC Various types of skeletal traction. 888.3040 Biomet, Inc. Component, Traction, Invasive JEC Various types of invasive traction 888.3040 Depuy Orthopaedics, Inc. components. Component, Traction, Invasive JEC Bone fixation system 888.3040 Intermedical Supplies Ltd. Component, Traction, Invasive JEC Dynamic azial fixation system 888.3040 Orthofix Srl Component, Traction, Invasive JEC Tibial retractor. 888.3040 Precision Medical Devices, Inc. Component, Traction, Invasive JEC Various types of invasive traction 888.3040 Smith & Nephew components Orthopaedics, Gmbh Component, Traction, Invasive JEC Various types of external fixation devices 888.3040 Stryker Trauma Ag (Sa) Component, Traction, Invasive JEC Various types and sizes of invasive traction 888.3040 Synthes (Usa) components. Component, Traction, Invasive JEC 888.3040 Zimmer Holdings, Inc. Polymer, ENT Synthetic, Porous JOF 874.3620 Tino, S.A. De C.V. Polyethylene Generator, Pulse, Pacemaker, JOQ 870.1750 Galix Biomedical External Programmable Instrumentation, Inc. Prosthesis, Knee, JWH Various types of knee prosthesis. 888.3560 Biomet, Inc. Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH 888.3560 Centerpulse Orthopedics Inc. Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer

Source: MDRWeb.com 162 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Knee, JWH Total knee prosthesis. 888.3560 Conformis, Inc. Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Nuffield Total Knee, Nuffield Total Knee 888.3560 Corin Group Limited Patellofemorotibial, Semi- UHMWPF Tibia (1 piece), Posterior Stabilized Constrained, Cemented, Polymer/ NTK, Plasma Coated NTK System. Metal/Polymer Prosthesis, Knee, JWH Modular knee porsthesis 888.3560 Depuy France S.A. Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Various types of semi-constrained, 888.3560 Depuy Orthopaedics, Inc. Patellofemorotibial, Semi- cemented, polymer/metal/polymer, Constrained, Cemented, Polymer/ patellofemor. Metal/Polymer Prosthesis, Knee, JWH Various types of semi-constrained, 888.3560 Depuy-Raynham, A Div. Of Patellofemorotibial, Semi- cemented, polymer/metal/polymer, Depuy Orthopaedics Constrained, Cemented, Polymer/ patellofemor. Metal/Polymer Prosthesis, Knee, JWH Knee system. 888.3560 Endotec, Inc. Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Various types of knees 888.3560 Howmedica International S. Patellofemorotibial, Semi- De R.L., Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Cemented total knee replacement 888.3560 Omni Life Science, Inc Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH 888.3560 Smith & Nephew Inc.- Patellofemorotibial, Semi- Orthopaedics Division Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Artificial knee replacement components. 888.3560 Stelkast Company Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Various types of knees. 888.3560 Stryker Howmedica Patellofemorotibial, Semi- Osteonics Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH 888.3560 Stryker Spine Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH 888.3560 Zimmer Holdings, Inc. Patellofemorotibial, Semi- Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Various plastic patellar surface 888.3560 Zimmer Manufacturing B.V. Patellofemorotibial, Semi- replacements. Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Knee, JWH Continuum knee system (cks). 888.3560 Zimmer Trabecular Metal Patellofemorotibial, Semi- Technology Constrained, Cemented, Polymer/ Metal/Polymer Prosthesis, Wrist, 2 Part Metal-Plastic JWI Cfv wrist system. 888.3800 Biomet, Inc. Articulation, Semi-constrained Prosthesis, Wrist, 3 Part Metal- JWJ Various types of wrist prosthesis. 888.3800 Biomet, Inc. Plastic-Metal Articulation, Semi- constrained Prosthesis, Wrist, 3 Part Metal- JWJ Various wrist prostheses with sterile and non- 888.3800 Depuy Orthopaedics, Inc. Plastic-Metal Articulation, Semi- sterile components. constrained

Source: MDRWeb.com 163 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Wrist, 3 Part Metal- JWJ SEMI-CONSTRAINED RE-MOTION TOTAL WRIST 888.3800 Small Bone Innovations, Inc. Plastic-Metal Articulation, Semi- constrained Prosthesis, Wrist, 3 Part Metal- JWJ Wrist joint metal/polymer semi-constrained 888.3800 Small Bone Innovations, Inc. Plastic-Metal Articulation, Semi- cemented prosthesis. constrained Prosthesis, Wrist, 3 Part Metal- JWJ 888.3800 Stryker Spine Plastic-Metal Articulation, Semi- constrained Shunt, Central Nervous System and JXG Shunt connector. 882.5550 Bioplate, Inc. Components Shunt, Central Nervous System and JXG 882.5550 Codman & Shurtleff, Inc Components Shunt, Central Nervous System and JXG Various styles and shapes of shunts and 882.5550 Integra Neurosciences Pr Components components. Shunt, Central Nervous System and JXG Central nervous system shunts & valves 882.5550 Medos S.A. Components Shunt, Central Nervous System and JXG Flow and siphon control shunt assembly & 882.5550 Medtronic Neurosurgery Components associated components. Shunt, Central Nervous System and JXG Thermal convection shunt analysis system. 882.5550 Neuro Diagnostic Devices Components Shunt, Central Nervous System and JXG Shunt. 882.5550 Qualitel Corporation Components Prosthesis, PTFE/Carbon-Fiber KDA ATRIUM ADVANTA PTFE vascular prosthesis. 878.3500 Atrium Medical Corp. Prosthesis, PTFE/Carbon-Fiber KDA Various sizes of proplast ii block implant 878.3500 Genetis S.A. material Catheter (Gastric, Colonic, Etc.), KDH Pediatric/adult lavage kit. 876.5980 Ballard Medical Products Irrigation and Aspiration Catheter (Gastric, Colonic, Etc.), KDH 876.5980 Covidien Lp Irrigation and Aspiration Catheter (Gastric, Colonic, Etc.), KDH Irrigation/aspiration catheter. 876.5980 Ethox International Irrigation and Aspiration Catheter (Gastric, Colonic, Etc.), KDH Gastrointestinal tubes and accessories and 876.5980 Kelsar, S.A. Irrigation and Aspiration kits Catheter (Gastric, Colonic, Etc.), KDH Irrigator. 876.5980 Medtec Applications, Inc. Irrigation and Aspiration Catheter (Gastric, Colonic, Etc.), KDH 876.5980 Wilson-Cook Medical, Inc. Irrigation and Aspiration Polymer, ENT Synthetic Polyamide KHJ Nasal-sinus and otologic dressing. 874.3620 Genzyme Corporation (Mesh Or Foil Material) Polymer, ENT Synthetic Polyamide KHJ Vocom. 874.3620 Gyrus Ent L.L.C., Sub. Of (Mesh Or Foil Material) Gyrus Acmi, Inc. Material, Polytetrafluoroethylene KKY 878.3500 Kerr Group Vitreous Carbon, For Maxillofacial Reconstruction Material, Polytetrafluoroethylene KKY Bone graft extender. 878.3500 Osteogenics Biomedical, Inc. Vitreous Carbon, For Maxillofacial Reconstruction Tube, Shunt, Endolymphatic With KLZ Arenberg inner ear valve shunt. 874.3850 E. Benson Hood Laboratories, Valve Inc. Prosthesis, Knee, Non-Constrained KMB Cemented and hydroxapatite. 888.3490 Joint Replacement (Metal-Carbon Reinforced Instrumentation Ltd. Polyethylene) Cemented Adapter, AV Shunt Or Fistula KNR Shunt adapter set (12/package) from 876.5540 Angiodynamics, Inc. the broadest line of A-V shunt products available. Accessories, Catheter, G-U KNY Wide array of accessories including 876.5130 Angiodynamics, Inc. guidewires, introducer needles, dilators, caps, clips, ties/tie guns, fluid barriers, and forceps. Accessories, Catheter, G-U KNY 876.5130 Applied Medical Resource Corporation Accessories, Catheter, G-U KNY Sterile catheter adapter and accessories. 876.5130 B. Braun Of Puerto Rico, Inc.

Source: MDRWeb.com 164 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Accessories, Catheter, G-U KNY 876.5130 Boston Scientific Corporation Accessories, Catheter, G-U KNY Various. 876.5130 Health Care Logistics, Inc. Accessories, Catheter, G-U KNY 876.5130 Medovations, Inc. Accessories, Catheter, G-U KNY Stainless-steel catheter connectors. 876.5130 Microcision Llc Accessories, Catheter, G-U KNY General urologic accessories. 876.5130 Nbs Medical Products Inc. Accessories, Catheter, G-U KNY Introducer sheath. 876.5130 Percutaneous Systems, Incorporated Accessories, Catheter, G-U KNY Introducer. 876.5130 Rtc Inc.-Memcath Technologies Llc Accessories, Catheter, G-U KNY Silicone Rubber Bolsters, Silicone Rubber 876.5130 Southside Biotechnology Spacers, Silicone Rubber YPort Adaptors Accessories, AV Shunt KNZ Connectors, adapters, and other 876.5540 Angiodynamics, Inc. accessories from the A-V shunt products line. Accessories, AV Shunt KNZ 876.5540 Lifemed Of California Catheter, Suprapubic (And KOB Various types and sizes of suprapubic 876.5090 Angiomed Gmbh & Co. Accessories) catheters and tubes Medizintechnik Kg Catheter, Suprapubic (And KOB 876.5090 C. R. Bard, Inc., Bard Accessories) Urological Div. Catheter, Suprapubic (And KOB 876.5090 Cook Urological, Inc. Accessories) Catheter, Suprapubic (And KOB 876.5090 Covidien Lp Accessories) Catheter, Suprapubic (And KOB Catheter, suprapubic (and accessories). 876.5090 Gyrus Acmi, Inc. Accessories) Catheter, Suprapubic (And KOB Priced $178.00 for a box of ten; available 876.5090 Laborie Medical Accessories) in sizes 16, 12 FR. Trocar and cannula only. Technologies Inc. Packaged sterile. Catheter, Suprapubic (And KOB 10-14 Fr., silicone. 876.5090 Manufacturing & Research, Accessories) Inc.(Dba Mri Medical) Catheter, Urological KOD Closed system intermittent catheterization 876.5130 Apogee Medical, Llc kit. Catheter, Urological KOD Infusion/aspiration device. 876.5130 Apple Medical Corp. Catheter, Urological KOD Gastroenterology catheter. 876.5130 Argon Medical Devices Inc. Catheter, Urological KOD Guide wire; accessory to urological 876.5130 Ashitaka Factory Of Terumo catheter Corporation Catheter, Urological KOD Intermittent urinary catheter. 876.5130 Biosearch Medical Products, Inc. Catheter, Urological KOD 876.5130 C. R. Bard, Inc., Bard Urological Div. Catheter, Urological KOD 876.5130 Coloplast Manufacturing Us, Llc Catheter, Urological KOD 876.5130 Cook Urological, Inc. Catheter, Urological KOD Urological catheters 876.5130 Erchinger Medizintecnik Catheter, Urological KOD Female catheter. 876.5130 Gilbert Surgical Instruments, Inc. Catheter, Urological KOD Securement accessories for catheter holder. 876.5130 Health Care Logistics, Inc. Catheter, Urological KOD 876.5130 Healthtronics Inc. Catheter, Urological KOD Foley catheters, and kits (all types) 876.5130 Kelsar, S.A. Catheter, Urological KOD 876.5130 Life-Tech, Inc. Catheter, Urological KOD 6-30 Fr., silicone. 876.5130 Manufacturing & Research, Inc.(Dba Mri Medical) Catheter, Urological KOD 876.5130 Medline Industries, Inc. Catheter, Urological KOD Urethral, 2-way, 3-way and pediatric. 876.5130 Mentor Corp. Catheter, Urological KOD Drainage catheter, urological catheter 876.5130 Mmj S.A. De C.V. Catheter, Urological KOD Fluid administration accessory. 876.5130 Navilyst Medical

Source: MDRWeb.com 165 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Urological KOD URI-CATH silicone urinary drainage catheter 876.5130 Utah Medical Products, Inc. for collection of urine & accurate output measurement, available as part of a set or separately. Catheter, Urological KOD Catheter, urological 876.5130 Vehu Medical Instrumente Gmbh Shunt, Peritoneal KPM LeVeen Peritoneo Venous Shunt 876.5955 Becton Dickinson And Co. Shunt, Peritoneal KPM Pleuro-peritoneal shunt for management of 876.5955 Denver Biomedical, Inc. intractable pleural effusions. Catheter, Continuous Flush KRA Steriflo. 870.1210 Argon Medical Devices Inc. Catheter, Continuous Flush KRA Continious flush catheter. 870.1210 Bacchus Vascular, Inc. Catheter, Continuous Flush KRA 870.1210 Boston Scientific - Maple Grove Catheter, Continuous Flush KRA Catheter. 870.1210 Boston Scientific- Neurovascular Catheter, Continuous Flush KRA Introducers. 870.1210 Clinical Instruments Intl., Inc. Catheter, Continuous Flush KRA Infusion catheters. 870.1210 Cordis Neurovascular, Inc. Catheter, Continuous Flush KRA Catheter, continuous flush. 870.1210 Edwards Lifesciences Technology Sarl Catheter, Continuous Flush KRA 870.1210 Edwards Lifesciences, Llc. Catheter, Continuous Flush KRA Various types of ultrasound infusion catheter 870.1210 Ekos Corp. systems. Catheter, Continuous Flush KRA Continuous flush catheter. 870.1210 Ev3 Neurovascular Catheter, Continuous Flush KRA 870.1210 Hospira, Inc. Catheter, Continuous Flush KRA Various continuous flush devices. 870.1210 Icu Medical (Ut), Inc Catheter, Continuous Flush KRA Various types of microcatheters. 870.1210 Impact Medical Technologies, Llc Catheter, Continuous Flush KRA 870.1210 Medical Murray Inc. Catheter, Continuous Flush KRA Microsyringe. 870.1210 Mercator Medsystems, Inc. Catheter, Continuous Flush KRA Thrombolytic catheters. Fountain Series 870.1210 Merit Medical Systems, Inc. Catheters. Catheter, Continuous Flush KRA 870.1210 Smiths Medical OEM Catheter, Continuous Flush KRA 870.1210 Vascular Insights LLC Analyzer, Pacemaker Generator KRE 870.3640 Instromedix, A Card Guard Function, Indirect Co. Analyzer, Pacemaker Generator KRE Pacemaker analyzer and 12 lead 870.3640 Medtronic Inc, Paceart Function, Indirect electrode. Analyzer, Pacemaker Generator KRE 870.3640 Omni Medical Supply Inc. Function, Indirect Prosthesis, Knee, Femorotibial, KRO Finn total knee. 888.3510 Biomet, Inc. Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, KRO Various types of cemented metal/polymer 888.3510 Depuy Orthopaedics, Inc. Constrained, Cemented, Metal/ constrained femorotibial knee joint pros. Polymer Prosthesis, Knee, Femorotibial, KRO Various types of cemented metal/polymer 888.3510 Depuy-Raynham, A Div. Of Constrained, Cemented, Metal/ constrained femorotibial knee joint pros. Depuy Orthopaedics Polymer Prosthesis, Knee, Femorotibial, KRO 888.3510 Implex Corp. Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, KRO Multiple 888.3510 S.P.O.R.T. Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, KRO 888.3510 Stryker Spine Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Femorotibial, KRO 888.3510 Zimmer Holdings, Inc. Constrained, Cemented, Metal/ Polymer

Source: MDRWeb.com 166 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Knee, Femorotibial, KRO $5,750.00 for cementless APS-type. 888.3510 Sulzer Ortopadie Ltd Constrained, Cemented, Metal/ Polymer Prosthesis, Knee, Patello/femoral, KRR Protello-femoral resurfacing prosthesis 888.3540 Arthrosurface, Inc. Semi-Constrained, Cemented, system. Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR Various types of knee prosthesis. 888.3540 Biomet, Inc. Semi-Constrained, Cemented, Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR Natural-Knee Patellofemoral Joint. 888.3540 Centerpulse Orthopedics Inc. Semi-Constrained, Cemented, Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR Various types of knee prostheses, patello/ 888.3540 Depuy Orthopaedics, Inc. Semi-Constrained, Cemented, femoral, semi-constrained, cemented. Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR Various types of knee prostheses, patello/ 888.3540 Depuy-Raynham, A Div. Of Semi-Constrained, Cemented, femoral, semi-constrained, cemented. Depuy Orthopaedics Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR KineMatch cemented PFR custom built to 888.3540 Kinamed, Inc. Semi-Constrained, Cemented, patient CT data. Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR CEMENTED, METAL/POLYMER - MAKO 888.3540 Mako Surgical Corp. Semi-Constrained, Cemented, Modular Knee (MMK) System; Restoris MCK Metal/Polymer System; Restoris Multicompartmental Knee Sy; MULTIPLE Prosthesis, Knee, Patello/femoral, KRR 888.3540 Smith & Nephew Inc.- Semi-Constrained, Cemented, Orthopaedics Division Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR 888.3540 Stryker Spine Semi-Constrained, Cemented, Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR 888.3540 Wright Medical Group, Inc. Semi-Constrained, Cemented, Metal/Polymer Prosthesis, Knee, Patello/femoral, KRR 888.3540 Zimmer Holdings, Inc. Semi-Constrained, Cemented, Metal/Polymer Appliance, Fixation, Nail/blade/ KTT Alphatec external fixation system. 888.3030 Alphatec Spine, Inc. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Electric-ac powered manicure/pedicure set 888.3030 Arise Diffusion Sa plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT External fixation device. 888.3030 Ascent Healthcare Solutions plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Various types of external wrist plates. 888.3030 Biomet, Inc. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT 888.3030 Bolt Bethel, Llc plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Corifix Dynamic Hip Screw. 888.3030 Corin Group Limited plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Various 888.3030 Depuy Ace S.A.’R.L. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Various 888.3030 Depuy France S.A. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT 888.3030 Depuy Mitek, Inc. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Various types. 888.3030 Depuy Orthopaedics, Inc. plate Combination, Multiple Component

Source: MDRWeb.com 167 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Appliance, Fixation, Nail/blade/ KTT Various types. 888.3030 Depuy-Raynham, A Div. Of plate Combination, Multiple Depuy Orthopaedics Component Appliance, Fixation, Nail/blade/ KTT Various 888.3030 Howmedica International S. plate Combination, Multiple De R.L., Component Appliance, Fixation, Nail/blade/ KTT External wrist fixator. 888.3030 Millennium Medical plate Combination, Multiple Technologies, Inc. Component Appliance, Fixation, Nail/blade/ KTT Wrist plate. 888.3030 Nutek Orthopaedics, Llc plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Correction of length or deformity; Internal 888.3030 Orthofix Inc. plate Combination, Multiple fracture fixation - Hip Component Appliance, Fixation, Nail/blade/ KTT Distraction device femur. 888.3030 Orthonetx, Inc. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Single/multiple component metallic bone 888.3030 R&R Medical, Inc. plate Combination, Multiple fixation appliances and accessories. Component Appliance, Fixation, Nail/blade/ KTT Wrist fixator. 888.3030 Rigid Fx Orthopedics, plate Combination, Multiple Incorporated Component Appliance, Fixation, Nail/blade/ KTT Ring, wrist and dynamic fixators. 888.3030 Small Bone Innovations, Inc. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Single/multiple component metallic bone 888.3030 Small Bone Innovations, Inc. plate Combination, Multiple fixation appliances and accessories. Component Appliance, Fixation, Nail/blade/ KTT Appliance, fixation. 888.3030 Sterilmed, Inc. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT 888.3030 Stryker Spine plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTT Various 888.3030 Stuckenbrock Medizintechnik plate Combination, Multiple Gmbh Component Appliance, Fixation, Nail/blade/ KTT Various types and sizes of multiple 888.3030 Synthes (Usa) plate Combination, Multiple component fixation devices. Component Appliance, Fixation, Nail/blade/ KTT Prefabricated orthopedic appliances and 888.3030 Truform Orthotics & plate Combination, Multiple supports. Prosthetics Component Appliance, Fixation, Nail/blade/ KTT Screwdrivers, wrenches, taps, guide pins, 888.3030 Warsaw Orthopedic, Inc. plate Combination, Multiple etc. Component Appliance, Fixation, Nail/blade/ KTT Various. 888.3030 Zimmer Manufacturing B.V. plate Combination, Multiple Component Appliance, Fixation, Nail/blade/ KTW External fixation device. 888.3030 Ascent Healthcare Solutions plate Combination, Single Component Appliance, Fixation, Nail/blade/ KTW Various types of single component fixation 888.3030 Depuy Orthopaedics, Inc. plate Combination, Single appliances, nail/blade/plate comb. Component Appliance, Fixation, Nail/blade/ KTW Various types and sizes of single component 888.3030 Synthes (Usa) plate Combination, Single fixation devices. Component Appliance, Fixation, Nail/blade/ KTW Prefabricated orthopedic appliances and 888.3030 Truform Orthotics & plate Combination, Single supports. Prosthetics Component Appliance, Fixation, Nail/blade/ KTW Plate. 888.3030 Warsaw Orthopedic, Inc. plate Combination, Single Component

Source: MDRWeb.com 168 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Knee, Femorotibial, KTX MJS tm Total Knee System - anatomic total 888.3490 Osteoimplant Technology, Non-Constrained, Metal/composite knee system available in five sizes. Modular Inc. Cemented tibial plateau. Prosthesis, Toe, Hemi-, Phalangeal KWD Prosthesis, toe, hemi-phalangeal. 888.3730 Arthrex, Inc. Prosthesis, Toe, Hemi-, Phalangeal KWD Great toe resurfacing prosthesis. 888.3730 Arthrosurface, Inc. Prosthesis, Toe, Hemi-, Phalangeal KWD Ascension CMC/TMT 888.3730 Ascension Orthopedics, Inc. Prosthesis, Toe, Hemi-, Phalangeal KWD Great Toe toe hemi-phalangeal. 888.3730 Biopro, Inc. Prosthesis, Toe, Hemi-, Phalangeal KWD GREAT TOE IMPLANT 888.3730 Signal Medical Corp. Prosthesis, Toe, Hemi-, Phalangeal KWD SBI TRIHEDRON MTP HEMI GREAT TOE 888.3730 Small Bone Innovations, Inc. Prosthesis, Toe, Hemi-, Phalangeal KWD Toe joint phalangeal (hemi-toe) polymer 888.3730 Small Bone Innovations, Inc. prosthesis. Prosthesis, Finger, Polymer KWF Finger prosthesis [glue-on not implants]. 888.3230 Rocky Mountain Anaplastology, Inc. Prosthesis, Toe, Constrained, KWH 888.3720 Smith & Nephew Inc.- Polymer Orthopaedics Division Prosthesis, Elbow, Hemi-, Radial, KWI Prothesis, elbow joint radial head. 888.3170 Acumed Llc Polymer Prosthesis, Elbow, Hemi-, Radial, KWI Ascension MRH 888.3170 Ascension Orthopedics, Inc. Polymer Prosthesis, Elbow, Hemi-, Radial, KWI Various types of elbow prosthesis. 888.3170 Biomet, Inc. Polymer Prosthesis, Elbow, Hemi-, Radial, KWI Various types of elbow prostheses, hemi- 888.3170 Depuy Orthopaedics, Inc. Polymer radial, polymer. Prosthesis, Elbow, Hemi-, Radial, KWI RHEAD 888.3170 Small Bone Innovations, Inc. Polymer Prosthesis, Elbow, Hemi-, Radial, KWI Elbow joint radial (hemi-elbow) polymer 888.3170 Small Bone Innovations, Inc. Polymer prosthesis. Prosthesis, Elbow, Hemi-, Radial, KWI Radial head replacement. 888.3170 Zimmer Trabecular Metal Polymer Technology Appliance, Nail/Blade/Plate KWK Various models of appliances,nail/blade/ 888.3030 Dimeda Instrumente Gmbh Combination, Single Component plate comb.sing.coponent Appliance, Nail/Blade/Plate KWK 888.3030 Sulzer Ortopadie Ltd Combination, Single Component Appliance, Nail/Blade/Plate KWK Swann-Major heavy duty sterile blade with 888.3030 Swann-Morton Ltd. Combination, Single Component handles. Appliance, Nail/Blade/Plate KWK 888.3030 Truform Orthotics & Combination, Single Component Prosthetics Prosthesis, Hip, Hemi-, Femoral, KWL Hip prosthesis 888.3360 Depuy France S.A. Metal Prosthesis, Hip, Hemi-, Femoral, KWL Various types of metal hemi-femoral hip 888.3360 Depuy Orthopaedics, Inc. Metal prostheses. Prosthesis, Hip, Hemi-, Femoral, KWL Various 888.3360 Howmedica International S. Metal De R.L., Prosthesis, Hip, Hemi-, Femoral, KWL FURLONG Hydroxyapatite coated titanium 888.3360 Joint Replacement Metal alloy substrate for femoral hip component, Instrumentation Ltd. cement free. Prosthesis, Wrist, Semi-Constrained KWM 888.3800 Wright Medical Group, Inc. Appliance, Fixation, Spinal KWP Bacfix system. 888.3050 Abbott Spine, Inc. Interlaminal Appliance, Fixation, Spinal KWP Spinal interlaminal orthosis. 888.3050 Aesculap Implant Systems, Interlaminal Inc. Appliance, Fixation, Spinal KWP Spinal fixation system. 888.3050 Allez Spine, Llc Interlaminal Appliance, Fixation, Spinal KWP Pedicle screw system. 888.3050 Alphatec Spine, Inc. Interlaminal Appliance, Fixation, Spinal KWP 888.3050 Amedica Corporation Interlaminal Appliance, Fixation, Spinal KWP Titanium Hartshill System 888.3050 Centinel Spine Inc. Interlaminal

Source: MDRWeb.com 169 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Appliance, Fixation, Spinal KWP Corin Spinal System. 888.3050 Corin Group Limited Interlaminal Appliance, Fixation, Spinal KWP Pedicle screw. 888.3050 Depuy Spine, Inc. Interlaminal Appliance, Fixation, Spinal KWP ARRAY SPINAL FIXATION ; MULTIPLE; 888.3050 Ebi, Llc Interlaminal SPINELINK II; MULTIPLE Appliance, Fixation, Spinal KWP PROTEX CT CERVICOTHORACIC SPINAL SY; 888.3050 Globus Medical Inc. Interlaminal REVERE STABILIZATION SYSTEM; TEM Appliance, Fixation, Spinal KWP Cervical spinal implant. 888.3050 Integra Lifesciences Of Ohio Interlaminal Appliance, Fixation, Spinal KWP Spinal fixator. 888.3050 K2m, Inc. Interlaminal Appliance, Fixation, Spinal KWP Aspen; Lanx Spinal Fixation System 888.3050 Lanx Inc. Interlaminal Appliance, Fixation, Spinal KWP Hook holder 888.3050 Marida, Marianne Daniels Interlaminal Chir. Instr. Appliance, Fixation, Spinal KWP Interlaminal clamp. 888.3050 Medtronic Sofamor Danek Interlaminal Usa, Inc. Appliance, Fixation, Spinal KWP Spinal implants. 888.3050 Nuvasive, Inc. Interlaminal Appliance, Fixation, Spinal KWP Various. 888.3050 Orthotec, Llc Interlaminal Appliance, Fixation, Spinal KWP Anterior cervical plate. 888.3050 Scient’X Usa, Inc. Interlaminal Appliance, Fixation, Spinal KWP Spinal fixation system. 888.3050 Spinecraft Llc Interlaminal Appliance, Fixation, Spinal KWP Various types and sizes of spinal interlaminal 888.3050 Synthes (Usa) Interlaminal fixation devices. Appliance, Fixation, Spinal KWP Screw/rod spinal instrumentation. 888.3050 Theken Spine Llc Interlaminal Appliance, Fixation, Spinal KWP Pedicle screw system. 888.3050 Us Spine Inc. Interlaminal Appliance, Fixation, Spinal KWP Spinal implant fixation devices. 888.3050 Warsaw Orthopedic, Inc. Interlaminal Appliance, Fixation, Spinal KWP Multiple 888.3050 Wenzel Spine Inc. Interlaminal Appliance, Fixation, Spinal KWP Rod, hook, and screw spinal devices. 888.3050 Zimmer Spine, Inc. Interlaminal Appliance, Fixation, Spinal KWQ Bone fixation plate. 888.3060 Abbott Spine, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior locking plate. 888.3060 Advanced Spine Technology, Intervertebral Body Inc. Appliance, Fixation, Spinal KWQ Spinal fixation system. 888.3060 Allez Spine, Llc Intervertebral Body Appliance, Fixation, Spinal KWQ Deltaloc anterior cervical plate system. 888.3060 Alphatec Spine, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Valeo CP 888.3060 Amedica Corporation Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior cervical plate. 888.3060 Atlas Spine Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Blackstone Spinal Fixation System; MULTIPLE 888.3060 Blackstone Medical, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Hartshill Rect & Wires, Spinal Fixa 888.3060 Centinel Spine Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Corin spinal System. 888.3060 Corin Group Limited Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior cervical plating system. 888.3060 Covidien Lp, Formerly Intervertebral Body Registered As United States Surgical Appliance, Fixation, Spinal KWQ Anterior spine bone plate. 888.3060 Depuy Spine, Inc. Intervertebral Body

Source: MDRWeb.com 170 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Appliance, Fixation, Spinal KWQ Anterior cervical spine plate. 888.3060 Depuy-Raynham, A Div. Of Intervertebral Body Depuy Orthopaedics Appliance, Fixation, Spinal KWQ CITADEL ANTERIO; GATEWAY 888.3060 Globus Medical Inc. Intervertebral Body THORACOLUMBAR PLATE SYSTEM; REVERE STABILIZATION SYSTEM Appliance, Fixation, Spinal KWQ Cervical plate. 888.3060 Innovasis, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior cervical plate. 888.3060 K2m, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior cervical spine (acp) system. 888.3060 Lanx Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Spinal intervertebral body fixation orthosis. 888.3060 Macropore Biosurgery, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior fixation devices. 888.3060 Medtronic Puerto Rico Intervertebral Body Operations Co.,Med Rel Appliance, Fixation, Spinal KWQ Anterior fixation devices. 888.3060 Medtronic Sofamor Danek Intervertebral Body Usa, Inc. Appliance, Fixation, Spinal KWQ Spinal implants. 888.3060 Nuvasive, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior spine plates, cervical spine plates. 888.3060 Orthotec, Llc Intervertebral Body Appliance, Fixation, Spinal KWQ Cervical plate. 888.3060 Paramount Surgicals, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Cervical plate. 888.3060 Pisharodi Surgicals, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Cervical plate. 888.3060 Rsb Spine Llc. Intervertebral Body Appliance, Fixation, Spinal KWQ Spinal fixation device 888.3060 Schafer Micomed Gmbh Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior plate. 888.3060 Scient’X Usa, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior cervical plate system. 888.3060 Spinal Elements, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior cervical, spinal fixation system, 888.3060 Theken Spine Llc Intervertebral Body plate. Appliance, Fixation, Spinal KWQ Anterior spinal fixation plate. 888.3060 Theken Spine, Llc Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior spinal fixation device. 888.3060 Trans1 Incorporated Intervertebral Body Appliance, Fixation, Spinal KWQ Pedicle screw system. 888.3060 Us Spine Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Spinal fusion system. 888.3060 Ussc Puerto Rico, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Cervical plate. 888.3060 Vertebron, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Anterior implant fixation devices. 888.3060 Warsaw Orthopedic, Inc. Intervertebral Body Appliance, Fixation, Spinal KWQ Spider Cervical Plating System; Butrex 888.3060 X-Spine Systems, Inc. Intervertebral Body Butress Plating System Appliance, Fixation, Spinal KWQ Spinal intervertebral body fixation orthosis. 888.3060 Zimmer Spine, Inc. Intervertebral Body Prosthesis, Shoulder, Semi- KWS Univers total shoulder,prosthesis,semi- 888.3660 Arthrex, Inc. Constrained, Metal/Polymer contrained,metal/non-porous,cemented Cemented vari. Prosthesis, Shoulder, Semi- KWS Bio-modular shoulder, bi-angular shoulder. 888.3660 Biomet, Inc. Constrained, Metal/Polymer Cemented Prosthesis, Shoulder, Semi- KWS Select shoulder system and anatomical 888.3660 Centerpulse Orthopedics Inc. Constrained, Metal/Polymer shoulder system; humeral stems and Cemented humeral heads (standard and offset). Prosthesis, Shoulder, Semi- KWS Various types of shoulder prostheses, non- 888.3660 Depuy Orthopaedics, Inc. Constrained, Metal/Polymer constrained, metal/polymer cemented. Cemented

Source: MDRWeb.com 171 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Shoulder, Semi- KWS Various 888.3660 Howmedica International S. Constrained, Metal/Polymer De R.L., Cemented Prosthesis, Shoulder, Semi- KWS Shoulder devices. 888.3660 Zimmer Trabecular Metal Constrained, Metal/Polymer Technology Cemented Prosthesis, Shoulder, Non- KWT Various types of sterile & non-sterile shoulder 888.3650 Biomet, Inc. Constrained, Metal/Polymer components. Cemented Prosthesis, Shoulder, Non- KWT The SELECT Shoulder system pegged 888.3650 Centerpulse Orthopedics Inc. Constrained, Metal/Polymer and kelled all-poly glenoid components. Cemented Anatomical shoulder system all-poly glenoids. Prosthesis, Shoulder, Non- KWT Various types of shoulder prostheses, non- 888.3650 Depuy Orthopaedics, Inc. Constrained, Metal/Polymer constrained, metal/polymer cemented. Cemented Prosthesis, Shoulder, Non- KWT Buechel-pappas glenoid bearing. 888.3650 Endotec, Inc. Constrained, Metal/Polymer Cemented Prosthesis, Shoulder, Non- KWT Shoulder implant. 888.3650 Stelkast Company Constrained, Metal/Polymer Cemented Prosthesis, Shoulder, Non- KWT Shoulder devices. 888.3650 Zimmer Trabecular Metal Constrained, Metal/Polymer Technology Cemented Prosthesis, Hip, Hemi-, Femoral, KWY Various types of hip[ prostheses. 888.3390 Biomet, Inc. Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Biotechnology porous coated hip stem. 888.3390 Bio-Technology Usa, Inc. Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Bipolar and unipolar endoprostheses. 888.3390 Centerpulse Orthopedics Inc. Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Corin Bipolar (titanium)&(cobalt chrome) 888.3390 Corin Group Limited Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Hip prosthesis for hemi arthroplasty 888.3390 Depuy France S.A. Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Various types of cemented or uncemented 888.3390 Depuy Orthopaedics, Inc. Metal/Polymer, Cemented or metal/polymer, hemi-, femoral, hip prost. Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Various types of cemented or uncemented 888.3390 Depuy-Raynham, A Div. Of Metal/Polymer, Cemented or metal/polymer, hemi-, femoral, hip prost. Depuy Orthopaedics Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY B2 Bipolar Cup. HEMISPHERE Modular Cup; 888.3390 Ortho Development Corp. Metal/Polymer, Cemented or cementless and cemented. Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY 888.3390 Smith & Nephew Inc.- Metal/Polymer, Cemented or Orthopaedics Division Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY 888.3390 Stryker Spine Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY 888.3390 Zimmer Holdings, Inc. Metal/Polymer, Cemented or Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY Hip joint femoral (hemi-hip) metal/polymer 888.3390 Zimmer Manufacturing B.V. Metal/Polymer, Cemented or cemented or cemented or uncemented pr. Uncemented Prosthesis, Hip, Hemi-, Femoral, KWY A-240 hep cemented hedrocel. 888.3390 Zimmer Trabecular Metal Metal/Polymer, Cemented or Technology Uncemented Prosthesis, Hip, Constrained, KWZ Various types of hip prosthesis. 888.3310 Biomet, Inc. Cemented or Uncemented, Metal/ Polymer

Source: MDRWeb.com 172 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Constrained, KWZ Various types. 888.3310 Depuy Orthopaedics, Inc. Cemented or Uncemented, Metal/ Polymer Prosthesis, Hip, Constrained, KWZ Various types. 888.3310 Depuy-Raynham, A Div. Of Cemented or Uncemented, Metal/ Depuy Orthopaedics Polymer Prosthesis, Hip, Constrained, KWZ Buechel-pappas self-aligning acetabular 888.3310 Endotec, Inc. Cemented or Uncemented, Metal/ component. Polymer Prosthesis, Hip, Constrained, KWZ 888.3310 Fournitures Hosptialieres Sa Cemented or Uncemented, Metal/ Polymer Prosthesis, Hip, Femoral, Resurfacing KXA Femoral head resurfacing prosthesis. 888.3400 Arthrosurface, Inc. Prosthesis, Hip, Femoral, Resurfacing KXA Various resurfacing femoral hip 888.3400 Biomet, Inc. components. Prosthesis, Hip, Femoral, Resurfacing KXA Tara Hip hip femoral resurfacing. 888.3400 Biopro, Inc. Prosthesis, Hip, Femoral, Resurfacing KXA 888.3400 Centerpulse Orthopedics Inc. Prosthesis, Hip, Femoral, Resurfacing KXA 888.3400 Sulzer Ortopadie Ltd Prosthesis, Wrist, Hemi-, Ulnar KXE Distal ulna. 888.3810 Aptis Medical, Llc. Prosthesis, Wrist, Hemi-, Ulnar KXE SIGMOID NOTCH; UHEAD 888.3810 Small Bone Innovations, Inc. Prosthesis, Wrist, Hemi-, Ulnar KXE Wrist joint ulnar (hemi-wrist) polymer 888.3810 Small Bone Innovations, Inc. prosthesis. Implant, Eye Valve KYF Krupin eye valve implant in 4 sizes, ultra- 886.3920 E. Benson Hood Laboratories, smooth surface treatment. Inc. Implant, Eye Valve KYF Glaucoma/aqueous shunt. 886.3920 Glaukos Corp. Implant, Eye Valve KYF Orbital floor implant for blowout fractures of 886.3920 John J. Kelley Associates Ltd. the orbit (teflon). Implant, Eye Valve KYF GLAUCOMA DEVICES, GLAUCOMA SHUNTS, 886.3920 New World Medical, Inc. GLAUCOMA VALVES, TUBE INSERTERS, FORCEPS, PERICARDIUM AND SCLERAL TISSUE Prosthesis, Wrist, Carpal Trapezium KYI Ascension PHS 888.3770 Ascension Orthopedics, Inc. Prosthesis, Wrist, Carpal Trapezium KYI SILICONE TRL; 888.3770 Small Bone Innovations, Inc. Prosthesis, Wrist, Carpal Trapezium KYI Wrist joint carpal trapezium polymer 888.3770 Small Bone Innovations, Inc. prosthesis. Prosthesis, Wrist, Carpal Trapezium KYI 888.3770 Wright Medical Group, Inc. Prosthesis, Finger, Constrained, KYJ Ascension PIP 888.3230 Ascension Orthopedics, Inc. Polymer Prosthesis, Finger, Constrained, KYJ Mutiple. 888.3230 Depuy Orthopaedics, Inc. Polymer Prosthesis, Finger, Constrained, KYJ Finger joint polymer constrained prosthesis. 888.3230 Small Bone Innovations, Inc. Polymer Prosthesis, Knee, Femorotibial, Semi- KYK Restoris Multicompartmental Knee System; 888.3500 Mako Surgical Corp. Constrained, Cemented, Metal/ RMCK composite Dynamometer, AC-Powered LBB Isometric strength dynamometer. 888.1240 Ametek Dynamometer, AC-Powered LBB Ac powered dynamometer. 888.1240 Cybernetic Research Laboratories, Inc. Dynamometer, AC-Powered LBB Dynamometers and Force Gauges for 888.1240 Elis - Electronic Instruments & isometric muscle stregth testing, job task Systems S.R.L. analysis and ADA compliance Dynamometer, AC-Powered LBB 888.1240 JTECH Medical Dynamometer, AC-Powered LBB Force measurement device. 888.1240 Kada Research, Inc. Dynamometer, AC-Powered LBB Spinal stiffness gauge. 888.1240 Mekanika, Inc. Porous Polyethylene Ossicular LBM 874.3450 Jedmed Instruments Co. Replacement Replacement, Total Ossicular, LBN 874.3495 Jedmed Instruments Co. Prosthesis, Porous, Polyethylene Electrode, Pacemaker, Temporary LDF Sterile temporary pacing catheters. 870.3680 Alpha Medical Instruments Llc

Source: MDRWeb.com 173 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Electrode, Pacemaker, Temporary LDF Electrode, pacemaker, temporary. 870.3680 Edwards Lifesciences Technology Sarl Electrode, Pacemaker, Temporary LDF PACEMAKER TEMPORARY ELECTRODE 870.3680 Edwards Lifesciences, Llc. Electrode, Pacemaker, Temporary LDF Sterile temporary pacing wire. 870.3680 Ethicon, Llc. Electrode, Pacemaker, Temporary LDF Uni and Bi-Polar electordes. 870.3680 Medipoint Gmbh Electrode, Pacemaker, Temporary LDF Various models. 870.3680 Medtronic Heart Valves Electrode, Pacemaker, Temporary LDF 870.3680 Navilyst Medical Electrode, Pacemaker, Temporary LDF Temporary pacing lead. 870.3680 Oscor, Inc. Electrode, Pacemaker, Temporary LDF ECG Adapter; Pacel 870.3680 St. Jude Medical Atrial Fibrillation Electrode, Pacemaker, Temporary LDF Cardiac pacing wire. 870.3680 Teleflex Medical Electrode, Pacemaker, Temporary LDF Stainless steel, coated 870.3680 Tyco Healthcare Uk Ltd. Electrode, Pacemaker, Temporary LDF Temporary pacing lead 870.3680 Vascomed Institut Fur Kathetertechnologie Gmbh Catheter, Femoral LFK Dual and single lumen for hemodialysis, 876.5540 Angiodynamics, Inc. and CAVH catheters for continuous hemofiltration. Catheter, Femoral LFK Introducers. 876.5540 Clinical Instruments Intl., Inc. Catheter, Femoral LFK Cavh catheter. 876.5540 Medron, Inc. Prosthesis, Knee, Femorotibial, Semi- LGE Various 888.3530 Howmedica International S. Constrained, Cemented, Trunnion- De R.L., bearing Prosthesis, Knee, Femorotibial, Semi- LGE 888.3530 Stryker Spine Constrained, Cemented, Trunnion- bearing Catheter, Angioplasty, Peripheral, LIT Peripheral catheter. 870.1250 Abbott Vascular, Cardiac Transluminal Therapies Catheter, Angioplasty, Peripheral, LIT Peripheral catheter. 870.1250 Abbott Vascular, Vascular Transluminal Solutions Catheter, Angioplasty, Peripheral, LIT Catheter. 870.1250 Angioscore, Inc. Transluminal Catheter, Angioplasty, Peripheral, LIT Atrium Hyperlite Angioplasty Balloon. 870.1250 Atrium Medical Corp. Transluminal Catheter, Angioplasty, Peripheral, LIT BIPORE, PTA Balloons. 870.1250 Bipore, Inc. Transluminal Catheter, Angioplasty, Peripheral, LIT Pta catheter. 870.1250 Bolton Medical, Inc. Transluminal Catheter, Angioplasty, Peripheral, LIT 870.1250 Cardio-Nef, S.A. De C.V. Transluminal Catheter, Angioplasty, Peripheral, LIT 870.1250 Cook Inc. Transluminal Catheter, Angioplasty, Peripheral, LIT Creganna Designs, Develops & 870.1250 Creganna Medical Devices Transluminal Manufactures Minimally Invasive Delivery Systems for Medical Devices OEMs. Catheter, Angioplasty, Peripheral, LIT Pta balloon catheter. 870.1250 Insitu Technologies, Inc. Transluminal Catheter, Angioplasty, Peripheral, LIT TriActiv Embolic Protection System 870.1250 Kensey Nash Corporation Transluminal combines balloon protection, active flush and automated extraction to treat occluded saphenous vein grafts. Catheter, Angioplasty, Peripheral, LIT Various types of angioplasty accessories. 870.1250 Navilyst Medical Transluminal Catheter, Angioplasty, Peripheral, LIT Catheters. 870.1250 Norfolk Medical Products, Transluminal Inc. Catheter, Angioplasty, Peripheral, LIT Pediatric PTV catheter. 870.1250 Numed, Inc. Transluminal Catheter, Angioplasty, Peripheral, LIT Guidewire. 870.1250 Radius Medical Technologies, Transluminal Inc. Catheter, Angioplasty, Peripheral, LIT Hemostatic wye connector. 870.1250 Thomas Medical Products, Transluminal Inc.

Source: MDRWeb.com 174 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Intravascular, Therapeutic, LJS Long-term silicone dialysis and critical care 880.5970 Angiodynamics, Inc. Long-term Greater Than 30 Days catheters in varying lumen configurations, lengths, and french sizes. Catheter, Intravascular, Therapeutic, LJS Sterile needleless injection hub 880.5970 Arrow Internacional De Long-term Greater Than 30 Days Mexico, S.A. De C.V. Catheter, Intravascular, Therapeutic, LJS Various styles & sizes of long term catheters 880.5970 Bard Reynosa S.A. De C.V. Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS Catheters. 880.5970 Bard Shannon Limited Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS 880.5970 Becton Dickinson And Long-term Greater Than 30 Days Company Catheter, Intravascular, Therapeutic, LJS Various. 880.5970 Catheter Innovations, Inc. Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS Catheter positioning locating instrument 880.5970 Corpak Medsystems, Inc. Long-term Greater Than 30 Days and accesories. Catheter, Intravascular, Therapeutic, LJS Intravascular catheter. 880.5970 Covidien Lp, Formerly Long-term Greater Than 30 Days Registered As United States Surgical Catheter, Intravascular, Therapeutic, LJS Endoluminal brush. 880.5970 Crs Medical Diagnostics Inc. Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS Sapiens Tip Location System 880.5970 Dymax Corp. Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS 880.5970 Embo-Optics, Llc. Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS Peripherally inserted central catheter 880.5970 Johnson & Johnson De Long-term Greater Than 30 Days Monterrey, Sa De Cv Catheter, Intravascular, Therapeutic, LJS Vascular catheter. 880.5970 Medtronic Neurosurgery Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS Central venous catheters and catheter 880.5970 Navilyst Medical Long-term Greater Than 30 Days accessories.; MULTIPLE Catheter, Intravascular, Therapeutic, LJS Chemo-cath subclavian. 880.5970 Neo Medical Inc. Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS NEO PICC (Peripherally Inserted Central 880.5970 Neo-Care Arrow International Long-term Greater Than 30 Days Catheter). Catheter, Intravascular, Therapeutic, LJS Catheter. 880.5970 Qualitel Corporation Long-term Greater Than 30 Days Catheter, Intravascular, Therapeutic, LJS PICC-NATE®, a PICC used specifically in 880.5970 Utah Medical Products, Inc. Long-term Greater Than 30 Days neonatal patients for administration of medications for a long duration of time. Catheter, Intravascular, Therapeutic, LJS Percutaneous intravascular catheter 880.5970 Vygon S A Long-term Greater Than 30 Days Port & Catheter, Implanted, LJT New Introcan Safety IV Catheter with a 880.5965 B. Braun Oem Division, B. Subcutaneous, Intravascular passive design to minimize needlestick Braun Medical Inc. injuries without requiring change in technique. Port & Catheter, Implanted, LJT Implanted ports 880.5965 Bard Reynosa S.A. De C.V. Subcutaneous, Intravascular Port & Catheter, Implanted, LJT Intravasular implanted port. 880.5965 Catheter Innovations, Inc. Subcutaneous, Intravascular Port & Catheter, Implanted, LJT 880.5965 Cook Vascular, Incorporated Subcutaneous, Intravascular Port & Catheter, Implanted, LJT Infusion port and catheter. 880.5965 Covidien Lp, Formerly Subcutaneous, Intravascular Registered As United States Surgical Port & Catheter, Implanted, LJT Vascular access port and catheter. 880.5965 Medtronic Neurosurgery Subcutaneous, Intravascular Port & Catheter, Implanted, LJT Various types of implanted vascular 880.5965 Navilyst Medical Subcutaneous, Intravascular access ports and vascular access port kits.; MULTIPLE Port & Catheter, Implanted, LJT Subcutaneous intravascular access device. 880.5965 Neo Medical Inc. Subcutaneous, Intravascular Port & Catheter, Implanted, LJT Catheters. 880.5965 Norfolk Medical Products, Subcutaneous, Intravascular Inc.

Source: MDRWeb.com 175 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Port & Catheter, Implanted, LJT Infusion port and catheter. 880.5965 Ussc Puerto Rico, Inc. Subcutaneous, Intravascular Bone Cement LOD Polymethylmethacrylate (pmma) bone 888.3027 Advanced Biomaterial cement. Systems, Inc. Bone Cement LOD Pmma bone cement. 888.3027 Biomet, Inc. Bone Cement LOD 888.3027 Dentsply Canada, Ltd. Bone Cement LOD 888.3027 Dentsply International, Inc. Bone Cement LOD Bone cement restictor 888.3027 Depuy Bioland Bone Cement LOD Various. 888.3027 Depuy Orthopaedics, Inc. Bone Cement LOD Bone cement 888.3027 Howmedica International S. De R.L., Bone Cement LOD 888.3027 Smith & Nephew Plc. Bone Cement LOD Bone cement. 888.3027 Stryker Instruments, Instruments Div. Bone Cement LOD Bone cement 888.3027 Teknimed Sa Catheter, Transluminal Coronary LOX Ptca catheters. 870.5100 Abbott Vascular, Cardiac Angioplasty, Percutaneous Therapies Catheter, Transluminal Coronary LOX ATRIUM HYPERLITE coronary angioplasty 870.5100 Atrium Medical Corp. Angioplasty, Percutaneous balloon catheters, and FLYER balloon- expandable coronary stents and Advanta V-12 peripheral PTFE-covered stent graft systems. Catheter, Transluminal Coronary LOX Percutaneous transluminal coronary 870.5100 Avantec Vascular Corp. Angioplasty, Percutaneous angioplasty catheter. Catheter, Transluminal Coronary LOX Ptca catheters - various types. 870.5100 Bolton Medical, Inc. Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX Disposable medical devices, principally 870.5100 Boston Scientific - Maple Angioplasty, Percutaneous coronary and peripheral angioplasty Grove catheters, for non-surgical treatment of cardiovascular disease. Catheter, Transluminal Coronary LOX Percutaneous, transluminal coronary 870.5100 Boston Scientific - Marina Bay Angioplasty, Percutaneous angioplasty catheters. Customer Fulfillment Center Catheter, Transluminal Coronary LOX SOFTRAC-PTA peripheral dilatation catheter; 870.5100 Boston Scientific Corp. Angioplasty, Percutaneous MONORAIL PICOLINO coronary dilatation catheter. Catheter, Transluminal Coronary LOX 870.5100 Boston Scientific Corporation Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX Percutaneous transluminal coronary 870.5100 Boston Scientific Ireland, Ltd. Angioplasty, Percutaneous angoplasty catheters Catheter, Transluminal Coronary LOX 870.5100 Cardio-Nef, S.A. De C.V. Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX 870.5100 Cook Inc. Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX Creganna Designs, Develops & 870.5100 Creganna Medical Devices Angioplasty, Percutaneous Manufactures Minimally Invasive Delivery Systems for Medical Devices OEMs. Catheter, Transluminal Coronary LOX 870.5100 Drg International, Inc. Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX Ptca catheter. 870.5100 Insitu Technologies, Inc. Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX Various. 870.5100 Intella Interventional Systems, Angioplasty, Percutaneous Inc. Catheter, Transluminal Coronary LOX 14K, 18K, OMNIFLEX, THRUFLEX, THRUFLEX II, 870.5100 Medtronic, Inc. Angioplasty, Percutaneous MAINE GUIDE, SPIRIT, SAFETIP, SHERPA. Catheter, Transluminal Coronary LOX 870.5100 Numed Canada, Inc. Angioplasty, Percutaneous Catheter, Transluminal Coronary LOX Ptca catheter. 870.5100 Volcano Corporation Angioplasty, Percutaneous Prosthesis, Hip, Semi-Constrained, LPH Various types of hip prosthesis. 888.3358 Biomet, Inc. Metal/Polymer, Porous Uncemented

Source: MDRWeb.com 176 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Semi-Constrained, LPH APR Porous Hip System; Inbter-Op 888.3358 Centerpulse Orthopedics Inc. Metal/Polymer, Porous Uncemented Acetabular System; Natural-Hip Porous Hip System and Inter-Op Durasul Acetabular insert system. Prosthesis, Hip, Semi-Constrained, LPH Various types. 888.3358 Depuy Orthopaedics, Inc. Metal/Polymer, Porous Uncemented Prosthesis, Hip, Semi-Constrained, LPH Various types. 888.3358 Depuy-Raynham, A Div. Of Metal/Polymer, Porous Uncemented Depuy Orthopaedics Prosthesis, Hip, Semi-Constrained, LPH Eska modular hip system 888.3358 Eska Implants Gmbh & Co. Metal/Polymer, Porous Uncemented Prosthesis, Hip, Semi-Constrained, LPH Prosthesis, hip, semi-constrained, metal 888.3358 Global Medical Company Metal/Polymer, Porous Uncemented polymer. Prosthesis, Hip, Semi-Constrained, LPH Various types of hips 888.3358 Howmedica International S. Metal/Polymer, Porous Uncemented De R.L., Prosthesis, Hip, Semi-Constrained, LPH 888.3358 Implex Corp. Metal/Polymer, Porous Uncemented Prosthesis, Hip, Semi-Constrained, LPH Hip prosthesis, uncemented. 888.3358 Omni Life Science, Inc Metal/Polymer, Porous Uncemented Prosthesis, Hip, Semi-Constrained, LPH 888.3358 Osteoimplant Technology, Metal/Polymer, Porous Uncemented Inc. Prosthesis, Hip, Semi-Constrained, LPH Mrs-titan 888.3358 Rotec Medizintechnik Gmbh Metal/Polymer, Porous Uncemented Prosthesis, Hip, Semi-Constrained, LPH Hip replacement system.; POROUS, 888.3358 Signal Medical Corp. Metal/Polymer, Porous Uncemented COATED, POLYMER/METAL/POLYMER - ; Micro-seal Acetabular System Prosthesis, Hip, Semi-Constrained, LPH 888.3358 Smith & Nephew Inc.- Metal/Polymer, Porous Uncemented Orthopaedics Division Prosthesis, Hip, Semi-Constrained, LPH Various types of hips. 888.3358 Stryker Howmedica Metal/Polymer, Porous Uncemented Osteonics Prosthesis, Hip, Semi-Constrained, LPH 888.3358 Stryker Spine Metal/Polymer, Porous Uncemented Prosthesis, Hip, Semi-Constrained, LPH Biological ingrowth anatomic hip stem, 888.3358 Zimmer Manufacturing B.V. Metal/Polymer, Porous Uncemented femoral stems, acetabular cups. Prosthesis, Hip, Semi-Constrained, LPH Sterile porous coated femoral hip stems. 888.3358 Zimmer Trabecular Metal Metal/Polymer, Porous Uncemented Technology Prosthesis, Hip, Semi-Constrained, LWJ Various types of hip prosthesis. 888.3360 Biomet, Inc. Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, LWJ Cti II, Modular Moore. 888.3360 Corin Group Limited Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, LWJ Various types of hip prostheses, semi- 888.3360 Depuy Orthopaedics, Inc. Metal/Polymer, Uncemented constrained, metal/polymer, uncemented. Prosthesis, Hip, Semi-Constrained, LWJ Various types of hip prostheses, semi- 888.3360 Depuy-Raynham, A Div. Of Metal/Polymer, Uncemented constrained, metal/polymer, uncemented. Depuy Orthopaedics Prosthesis, Hip, Semi-Constrained, LWJ Artificial hip replacement components. 888.3360 Stelkast Company Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, LWJ 888.3360 Stryker Spine Metal/Polymer, Uncemented Prosthesis, Hip, Semi-Constrained, LWJ Hip joint metal/polymer semi-constrained 888.3360 Zimmer Manufacturing B.V. Metal/Polymer, Uncemented uncemented prosthesis. Prosthesis, Hip, Semi-Constrained, LWJ Implex hedrocel acetabular augment. 888.3360 Zimmer Trabecular Metal Metal/Polymer, Uncemented Technology Appliance, Fixation, Nail/Blade/ LXT 888.3030 A.M. Surgical, Inc. Plate Combination, Multiple Component, Metal Composite Appliance, Fixation, Nail/Blade/ LXT Valeo CP 888.3030 Amedica Corporation Plate Combination, Multiple Component, Metal Composite Appliance, Fixation, Nail/Blade/ LXT Various types of fixation appliances. 888.3030 Biomet, Inc. Plate Combination, Multiple Component, Metal Composite Appliance, Fixation, Nail/Blade/ LXT Wujin #3 Plating System 888.3030 Biopro, Inc. Plate Combination, Multiple Component, Metal Composite

Source: MDRWeb.com 177 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Appliance, Fixation, Nail/Blade/ LXT Various types of fixation appliances, nail/ 888.3030 Depuy Orthopaedics, Inc. Plate Combination, Multiple blade/plate combination,multicomponet. Component, Metal Composite Appliance, Fixation, Nail/Blade/ LXT Nbx non-bridging external fixator. 888.3030 Nutek Orthopaedics, Llc Plate Combination, Multiple Component, Metal Composite Appliance, Fixation, Nail/Blade/ LXT Various types and sizes of multiple 888.3030 Synthes (Usa) Plate Combination, Multiple component, metal composite, fixation Component, Metal Composite devices. Bone Grafting Material, Synthetic LYC Bone filler. 872.3930 Bioform Medical, Inc. Bone Grafting Material, Synthetic LYC 872.3930 Biomet 3i Bone Grafting Material, Synthetic LYC Bone filling augmentation material. 872.3930 Biomet Microfixation Inc. Bone Grafting Material, Synthetic LYC Bone cement. 872.3930 Biomet, Inc. Bone Grafting Material, Synthetic LYC Biobar biodegradable collagen membrane 872.3930 Col-Bar Ltd. Bone Grafting Material, Synthetic LYC Collagen periodontal membrane. 872.3930 Collagen Matrix, Inc. Bone Grafting Material, Synthetic LYC Various types of sterile bone filling 872.3930 Dentsply Friadent Ceramed augmentation materials. Bone Grafting Material, Synthetic LYC Various types of sterile bone filling 872.3930 Dentsply Specialty Materials augmentation materials. Bone Grafting Material, Synthetic LYC Various sizes of proplast ha sheeting, 872.3930 Genetis S.A. reinforced sheeting and laminates Bone Grafting Material, Synthetic LYC Various. 872.3930 Gyrus Ent L.L.C., Sub. Of Gyrus Acmi, Inc. Bone Grafting Material, Synthetic LYC Gore-Tex, regenerative material barriers. 872.3930 Imtec, A 3m Company Bone Grafting Material, Synthetic LYC Bone graft substitute hydroxylapatite blocks 872.3930 Integra Spine synthetic bone substitute. Bone Grafting Material, Synthetic LYC Synthetic bone grafting material. 872.3930 Kerr Corp. Bone Grafting Material, Synthetic LYC CALFORMA Calcium Sulfate 872.3930 Lifecore Biomedical, Inc. Barrier. CALMATRIX Calcium Sulfate Binder. CAPSET Calcium Sulfate Barrier. TEFGEN Regenerative Membranes. Bone Grafting Material, Synthetic LYC Fixation pins. 872.3930 Luitpold Pharmaceuticals, Inc. Bone Grafting Material, Synthetic LYC Bone void filler material. 872.3930 Medtronic Sofamor Danek Usa, Inc. Bone Grafting Material, Synthetic LYC Perioglas - Sythetic Bone Graft Particulate; 872.3930 Novabone Products, Llc Bone Grafting Material, Synthetic LYC Various models of synthetic bone grafting 872.3930 Oct Usa, Inc. material. Bone Grafting Material, Synthetic LYC Resorbable regenerative membrane. 872.3930 Osteogenics Biomedical, Inc. Bone Grafting Material, Synthetic LYC Resorbable regenerative membrane. 872.3930 Smith & Nephew, Inc. Bone Grafting Material, Synthetic LYC Regen biocement. 872.3930 Steiner Laboratories Bone Grafting Material, Synthetic LYC Unigraft synthetic bioactive glass bone- 872.3930 Unicare Biomedical, Inc. graft material. Also, Cytoflex expanded PTFE synthetic barrier membrane for use as a space-making barrier in the treatment of periodontal defects. Bone Grafting Material, Synthetic LYC Periodontal material. 872.3930 W.L. Gore & Associates,Inc Bone Grafting Material, Synthetic LYC Regenerative material. 872.3930 W.L. Gore & Associates,Inc Accessories, Fixation, Spinal LYP 888.3050 Holmed Corporation Interlaminal Accessories, Fixation, Spinal LYP Spinal implant fixation device. 888.3050 Warsaw Orthopedic, Inc. Interlaminal Fixation Accessory LYT 888.3030 Acor Orthopaedic, Inc. Fixation Accessory LYT 888.3030 Allen Medical Systems, Inc. Fixation Accessory LYT POSTURITE orthopedic seating device made 888.3030 Back Support Systems from medical quality, high density foam that allows correct posture while seated in any chair. Comes with oil and water resistant cover. Fixation Accessory LYT 888.3030 Bolt Bethel, Llc

Source: MDRWeb.com 178 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Fixation Accessory LYT Various screws and instruments 888.3030 Crystal Medical Technology Fixation Accessory LYT 888.3030 Depuy Ace, A Johnson & Johnson Company Fixation Accessory LYT Accessories for fixation system 888.3030 Depuy France S.A. Fixation Accessory LYT Various types of fixation accessories. 888.3030 Depuy Orthopaedics, Inc. Fixation Accessory LYT Softgoods and Neoprene, general 888.3030 DJO Inc. accommodative orthopedic bracing. Fixation Accessory LYT 888.3030 Dynamic Surgical (Pvt.) Ltd. Fixation Accessory LYT 888.3030 Holmed Corporation Fixation Accessory LYT 888.3030 Kerr Group Fixation Accessory LYT Orthopedic Softgoods. 888.3030 Med Ag Fixation Accessory LYT Fixation accessory 888.3030 Ortho Medical Gmbh Implants Fixation Accessory LYT 888.3030 Overseas Medical Supplies (Uk) Ltd Fixation Accessory LYT 888.3030 Quatro Composites Fixation Accessory LYT Manufacturer of orthopedic devices. 888.3030 Rogers Foam Corp. Fixation Accessory LYT 888.3030 Smith & Nephew Plc. Fixation Accessory LYT Various types and sizes of fixation 888.3030 Synthes (Usa) accessories. Fixation Accessory LYT TELOS O.R. table accessories, standard and 888.3030 Telos Medical Equipment custom made. (Austin & Assoc., Inc.) Fixation Accessory LYT 888.3030 Teufel Gmbh & Co. Kg Fixation Accessory LYT Lower-extremity prosthetic accessories. 888.3030 Truform Orthotics & Prosthetics Pump, Infusion, Insulin LZG Aviator Insulin Pump 880.5725 Abbott Diabetes Care Inc. Pump, Infusion, Insulin LZG Pump, infusion, insulin. 880.5725 Animas Corp. Pump, Infusion, Insulin LZG Insulin infusion pump 880.5725 Disetronic Gmbh & Co. Kg Pump, Infusion, Insulin LZG Insulin infusion pump and remote controller. 880.5725 Insulet Corporation Pump, Infusion, Insulin LZG External and implantable models. 880.5725 Medtronic Minimed Pump, Infusion, Insulin LZG Infusion pump. 880.5725 Medtronic Puerto Rico Operations Co., Juncos Pump, Infusion, Insulin LZG Amigo Insulin Pump 880.5725 Nipro Diabetes Systems, Inc. Pump, Infusion, Insulin LZG 880.5725 Roche Insulin Delivery Systems Inc. Pump, Infusion, Insulin LZG Various 880.5725 Sooil Development Co., Ltd. Infusion Pump, Enteral LZH Patrol Enteral Nutrition Pump; Quantum 880.5725 Abbott Laboratories Enteral Nutrition Pump; ClearStar Companion Enteral Nutriti; Companion Enteral Nutrition Pump Infusion Pump, Enteral LZH 880.5725 Ardus Medical, Inc. Infusion Pump, Enteral LZH Large Volume Elastomeric Infusion; MULTIPLE 880.5725 Baxter Healthcare Corporation, Medication Delivery Infusion Pump, Enteral LZH Enternal feeding pump. 880.5725 Corpak Medsystems, Inc. Infusion Pump, Enteral LZH 880.5725 Covidien Lp, Formerly Registered As Kendall Infusion Pump, Enteral LZH Infusion pump, non sterile. 880.5725 Entracare, Llc Infusion Pump, Enteral LZH Enteral pump with formula delivery and 880.5725 Novartis Nutrition patient hydration modules. Infusion Pump, Enteral LZH 880.5725 Omni Medical Supply Inc. Infusion Pump, Enteral LZH Enteral feeding pump. 880.5725 Ost Medical Inc. Infusion Pump, Enteral LZH 880.5725 Zevex Incorporated Cement Obturator LZN 878.3300 Codman & Shurtleff, Inc Cement Obturator LZN Various types of cement obturators. 878.3300 Depuy Orthopaedics, Inc.

Source: MDRWeb.com 179 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Cement Obturator LZN Various 878.3300 Howmedica International S. De R.L., Cement Obturator LZN Obturator. 878.3300 Stryker Instruments, Instruments Div. Cement Obturator LZN Obturator. 878.3300 Stryker Puerto Rico, Ltd. Cement Obturator LZN Cement restrictor. 878.3300 Warsaw Orthopedic, Inc. Cement Obturator LZN Cement restrictor system. 878.3300 Zimmer Trabecular Metal Technology Prosthesis, Hip, Semi-Constrained, LZO Various types of hip prosthesis and ceramic 888.3353 Biomet, Inc. Metal/Ceramic/Polymer, Cemented head. or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO 888.3353 Centerpulse Orthopedics Inc. Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO Cenator Total Hip. 888.3353 Corin Group Limited Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO Various types of hip prostheses, semi- 888.3353 Depuy Orthopaedics, Inc. Metal/Ceramic/Polymer, Cemented constrained, metal/ceramic/polymer. or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO Various types of hip prostheses, semi- 888.3353 Depuy-Raynham, A Div. Of Metal/Ceramic/Polymer, Cemented constrained, metal/ceramic/polymer. Depuy Orthopaedics or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO Ceramic femoral head. 888.3353 Omni Life Science, Inc Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO 888.3353 Smith & Nephew Inc.- Metal/Ceramic/Polymer, Cemented Orthopaedics Division or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO Artificial hip replacement components. 888.3353 Stelkast Company Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO 888.3353 Stryker Spine Metal/Ceramic/Polymer, Cemented or Non-porous, Uncemented Prosthesis, Hip, Semi-Constrained, LZO F-102 zirconia-implex ceramic head. 888.3353 Zimmer Trabecular Metal Metal/Ceramic/Polymer, Cemented Technology or Non-porous, Uncemented System, Cement Removal Extraction LZV Ultrasonic surgical equipment. 888.4580 Biomet, Inc. System, Cement Removal Extraction LZV 888.4580 ConMed Linvatec System, Cement Removal Extraction LZV 888.4580 Micro-Aire Surgical Instruments, Inc. Prosthesis, Hip, Hemi-, Femoral, LZY Various types of sterile hip components. 888.3360 Biomet, Inc. Metal Ball Prosthesis, Hip, Hemi-, Femoral, LZY Hip endoprosthesis. 888.3360 Bio-Technology Usa, Inc. Metal Ball Prosthesis, Hip, Hemi-, Femoral, LZY Prosthesis, hip, hemi-, femoral, metal ball 888.3360 Depuy Orthopaedics, Inc. Metal Ball (various types). Prosthesis, Hip, Hemi-, Femoral, LZY Buechel-pappas femoral head. 888.3360 Endotec, Inc. Metal Ball Prosthesis, Hip, Hemi-, Femoral, LZY Multiple and various. 888.3360 Millstone Medical Metal Ball Outsourcing Fastener, Fixation, Biodegradable, MAI Various sterile bioabsorbable suture 888.3030 Arthrex, Inc. Soft Tissue anchors. Fastener, Fixation, Biodegradable, MAI Various types of lactosorb sterile & non- 888.3030 Biomet, Inc. Soft Tissue sterile. Fastener, Fixation, Biodegradable, MAI Brow lift device & installation kit. 888.3030 Coapt Systems, Inc. Soft Tissue Fastener, Fixation, Biodegradable, MAI BIO-ANCHOR absorbable tissue fixation 888.3030 ConMed Linvatec Soft Tissue implant. Fastener, Fixation, Biodegradable, MAI Bioderadable fastners. 888.3030 Covidien Lp, Formerly Soft Tissue Registered As United States Surgical

Source: MDRWeb.com 180 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Fastener, Fixation, Biodegradable, MAI Fastner, fixation, biodegradable soft tissue. 888.3030 Depuy Mitek, A Johnson & Soft Tissue Johnson Company Fastener, Fixation, Biodegradable, MAI 888.3030 Ethicon, Inc. Soft Tissue Fastener, Fixation, Biodegradable, MAI 888.3030 Karl Storz Endoscopy- Soft Tissue America Inc. Fastener, Fixation, Biodegradable, MAI Bone screws and tacks. 888.3030 Macropore Biosurgery, Inc. Soft Tissue Fastener, Fixation, Biodegradable, MAI Same. 888.3030 Mar-Lee Companies Soft Tissue Fastener, Fixation, Biodegradable, MAI Sterile soft tissue fixation devices and 888.3030 Scandius Biomedical, Inc. Soft Tissue instrumentation. Fastener, Fixation, Biodegradable, MAI Various fastener, fixation, biodegradable 888.3030 Stryker Instruments, Soft Tissue soft tissue. Instruments Div. Fastener, Fixation, Biodegradable, MAI Bio-absorbable bone anchor. 888.3030 Tornier Inc. Soft Tissue Fastener, Fixation, Biodegradable, MAI Bioberadable fastners. 888.3030 Ussc Puerto Rico, Inc. Soft Tissue Graft, Vascular, Synthetic/Biological MAL Nonbiological/composite. PTFE vascular 870.3450 Atrium Medical Corp. Composite grafts in a variety of sizes and configurations for peripheral and AV vascular reconstruction. Graft, Vascular, Synthetic/Biological MAL Under development. 870.3450 Corvita Corp. Composite Graft, Vascular, Synthetic/Biological MAL 870.3450 MAQUET Composite Graft, Vascular, Synthetic/Biological MAL HEMASHIELD 870.3450 Maquet Cardiovascular LLC Composite Intervertebral Fusion Device With MAX Spinal fusion device. 888.3080 Covidien Lp, Formerly Bone Graft, Lumbar Registered As United States Surgical Intervertebral Fusion Device With MAX Interbody fusion cage and posterior pedicle 888.3080 Depuy Spine, Inc. Bone Graft, Lumbar screw fixation system-sterile and no. Intervertebral Fusion Device With MAX Spinal fusion device. 888.3080 Medtronic Sofamor Danek Bone Graft, Lumbar Usa, Inc. Intervertebral Fusion Device With MAX Spinal intervertebral implant-fusion. 888.3080 Micron Precision Engineering, Bone Graft, Lumbar Inc. Intervertebral Fusion Device With MAX Spinal fusion device. 888.3080 Ussc Puerto Rico, Inc. Bone Graft, Lumbar Intervertebral Fusion Device With MAX Spinal fusion device. 888.3080 Warsaw Orthopedic, Inc. Bone Graft, Lumbar Intervertebral Fusion Device With MAX Interbody fusion cage. 888.3080 Zimmer Spine, Inc. Bone Graft, Lumbar Prosthesis, Hip, Semi-constrained, MAY Various types of sterile hip components. 888.3353 Biomet, Inc. Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish Prosthesis, Hip, Semi-constrained, MAY PSL Hip hip - metal/ceramic/PE. 888.3353 Biopro, Inc. Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish Prosthesis, Hip, Semi-constrained, MAY Femoral heads 888.3353 Depuy France S.A. Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish Prosthesis, Hip, Semi-constrained, MAY Mueller. 888.3353 Medtronic Sofamor Danek Metal/ceramic/polymer, Cemented Usa, Inc. Or Non-porous Cemented, Osteophilic Finish Prosthesis, Hip, Semi-constrained, MAY Mrp-titan 888.3353 Rotec Medizintechnik Gmbh Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish

Source: MDRWeb.com 181 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Semi-constrained, MAY Mueller. 888.3353 Warsaw Orthopedic, Inc. Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish Bone Cement, Antibiotic MBB Various types of bone cement. 888.3027 Biomet, Inc. Bone Cement, Antibiotic MBB Various types of antibiotic bone cement. 888.3027 Depuy Orthopaedics, Inc. Prosthesis, Shoulder, Semi- MBF Various types of sterile and non-sterile 888.3670 Biomet, Inc. Constrained, Metal/Polymer, shoulder prosthesis. Uncemented Prosthesis, Shoulder, Semi- MBF Various types uncemented, metal-poly, 888.3670 Depuy Orthopaedics, Inc. Constrained, Metal/Polymer, semi-const. shoulder. Uncemented Prosthesis, Knee, Pattello/ MBH Various types of knee components. 888.3565 Biomet, Inc. femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Prosthesis, Knee, Pattello/ MBH Various types. 888.3565 Depuy Orthopaedics, Inc. femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Prosthesis, Knee, Pattello/ MBH Various types. 888.3565 Depuy-Raynham, A Div. Of femorotibial, Semi-Constrained, Depuy Orthopaedics Uncemented, Porous, Coated, Polymer/Metal/Polymer Prosthesis, Knee, Pattello/ MBH Trabecular metal knee system augment. 888.3565 Zimmer Trabecular Metal femorotibial, Semi-Constrained, Technology Uncemented, Porous, Coated, Polymer/Metal/Polymer Fastener, Fixation, Nondegradable, MBI Bone anchor. 888.3040 Anspach Effort Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Rimclose Bone Anchor 888.3040 Anulex Technologies, Inc Soft Tissue Fastener, Fixation, Nondegradable, MBI Screw,fastener. 888.3040 Arthrex Manufacturing Soft Tissue Fastener, Fixation, Nondegradable, MBI Bone screws. 888.3040 Arthrex, Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Harpoon suture anchor. 888.3040 Biomet, Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Various. 888.3040 Bonutti Research, Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Bone anchor system. 888.3040 Boston Scientific - Marina Bay Soft Tissue Customer Fulfillment Center Fastener, Fixation, Nondegradable, MBI Renovo; TAC-tite(TM) 888.3040 Core Essence Orthopaedics Soft Tissue Inc. Fastener, Fixation, Nondegradable, MBI Fastener, fixation, non-biodegradable, soft 888.3040 Depuy Mitek, A Johnson & Soft Tissue tissue. Johnson Company Fastener, Fixation, Nondegradable, MBI Fastener, fixation, nondegradable, soft 888.3040 Depuy Orthopaedics, Inc. Soft Tissue tissue (various types). Fastener, Fixation, Nondegradable, MBI Various types of nondegradable soft tissue 888.3040 Depuy-Raynham, A Div. Of Soft Tissue fixation fasteners. Depuy Orthopaedics Fastener, Fixation, Nondegradable, MBI 888.3040 Ethicon, Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI 888.3040 Innovasive Devices, Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Opti-Fiber; WedgeLoc; Morphix; WedgeLoc 888.3040 MedShape Solutions Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Sterile soft tissue fixation devices and 888.3040 Scandius Biomedical, Inc. Soft Tissue instrumentation. Fastener, Fixation, Nondegradable, MBI Suture applicator. 888.3040 Tornier Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Soft tissue attachment anchor. 888.3040 Zimmer Holdings, Inc. Soft Tissue Fastener, Fixation, Nondegradable, MBI Implex screw and washer. 888.3040 Zimmer Trabecular Metal Soft Tissue Technology

Source: MDRWeb.com 182 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Semi-constrained, MBL Various types of sterile hip components. 888.3358 Biomet, Inc. Uncemented, Metal/Polymer, Porous Prosthesis, Knee, Patello/ MBV Various types of knee prosthesis. 888.3560 Biomet, Inc. femorotibial, Semi-Constrained, UHMWPE, Pegged, Uncemented, Polymer/Metal/Polymer Clip, Hemostatic MCH Endoscopic clipping device. 878.4300 Cook Endoscopy Clip, Hemostatic MCH 878.4300 Covidien Lp, Formerly Registered As United States Surgical Clip, Hemostatic MCH Various models of clips hemostatic 878.4300 Dimeda Instrumente Gmbh Clip, Hemostatic MCH 878.4300 Elmed, Inc. Clip, Hemostatic MCH Sterile and nonsterile ligating clips. 878.4300 Ethicon Endo-Surgery, Inc. Clip, Hemostatic MCH 878.4300 Mattes Instrumente Gmbh Clip, Hemostatic MCH 878.4300 Medicon Eg Clip, Hemostatic MCH 878.4300 Ustomed Instrumente - Ulrich Storz Gmbh & Co. Kg Catheter, Peripheral, Atherectomy MCW Peripheral atherectomy catheter. 870.4875 Abbott Vascular, Cardiac Therapies Catheter, Peripheral, Atherectomy MCW Peripheral atherectomy catheter. 870.4875 Bacchus Vascular, Inc. Catheter, Peripheral, Atherectomy MCW Diamondback 360; Orbital atherectomy 870.4875 Cardiovascular Systems, Inc. controller,sterile orbital atherectomy device. Catheter, Peripheral, Atherectomy MCW Percutaneous mechanical thrombectomy 870.4875 Edwards Lifesciences (pmt). Technology Sarl Catheter, Peripheral, Atherectomy MCW 870.4875 Edwards Lifesciences, Llc. Catheter, Peripheral, Atherectomy MCW Thrombectomy catheter. 870.4875 Ev3 Inc. Catheter, Peripheral, Atherectomy MCW Thrombolytic brush catheter. 870.4875 Ev3 Neurovascular Catheter, Peripheral, Atherectomy MCW Eliminator. 870.4875 Idev Technologies, Inc. Catheter, Peripheral, Atherectomy MCW Diamondback 360 Orbital Atherectomy 870.4875 Minnetronix Inc. Catheter, Peripheral, Atherectomy MCW 870.4875 Smiths Medical Asd, Inc. Pump, Infusion, PCA MEA 880.5725 Abbott Laboratories Pump, Infusion, PCA MEA Specialized repair services for leading PCA 880.5725 Aiv, Inc. (Formerly American pumps. AC Adapters available for sale as Iv) well. Pump, Infusion, PCA MEA 880.5725 Ardus Medical, Inc. Pump, Infusion, PCA MEA Pca infusor, basal-bolus, pca infusor.; 880.5725 Baxter Healthcare MULTIPLE Corporation, Medication Delivery Pump, Infusion, PCA MEA Verifuse. 880.5725 Integra Lifesciences Corp. Pump, Infusion, PCA MEA 880.5725 Mps Acacia Pump, Infusion, PCA MEA 880.5725 Smiths Medical Asd, Inc. Pump, Infusion, PCA MEA Infusion pump. 880.5725 Stryker Instruments, Instruments Div. Pump, Infusion, PCA MEA Various models of PCA infusion pumps. 880.5725 Walkmed Infusion Llc Pump, Infusion, Elastomeric MEB Elastomeric infusion pump. 880.5725 Advanced Infusion, Inc. Pump, Infusion, Elastomeric MEB Solace Post-Operative Pain Relief Infusion 880.5725 Apex Medical Technologies, System Inc. Pump, Infusion, Elastomeric MEB Infusor, elastomeric infusion pump. 880.5725 Baxter Healthcare Corporation, Medication Delivery Pump, Infusion, Elastomeric MEB Various types of infusion pumps. 880.5725 Biomet, Inc. Pump, Infusion, Elastomeric MEB Various 880.5725 Block Medical De Mexico S.A. De C.V. Pump, Infusion, Elastomeric MEB Pain care 2000. 880.5725 Breg, Inc., An Orthofix Company Pump, Infusion, Elastomeric MEB Multiple 880.5725 I-Flow Corporation Pump, Infusion, Elastomeric MEB Various models of infusion pumps, and 880.5725 Stryker Instruments, accessories. Instruments Div.

Source: MDRWeb.com 183 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pump, Infusion, Elastomeric MEB Disposable infusion pump kit. 880.5725 Symbios Medical Products, Llc Pump, Infusion, Elastomeric MEB Innsion pump, various sterile disposables 880.5725 Tandem Medical, Inc. and non-sterile non-disposables. Pump, Infusion, Elastomeric MEB Disposable ambulatory infuser. 880.5725 Walkmed Infusion Llc Prosthesis, Hip, Semi-Constrained, MEH Bio-groove ha. 888.3353 Biomet, Inc. Uncemented, Metal/polymer, Non- Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH Precedent revision hip system with HA 888.3353 Centerpulse Orthopedics Inc. Uncemented, Metal/polymer, Non- coating. Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH Various 888.3353 Depuy France S.A. Uncemented, Metal/polymer, Non- Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH Various types of hip prostheses, (semi- 888.3353 Depuy Orthopaedics, Inc. Uncemented, Metal/polymer, Non- constrained, uncemented, metal/polymer. Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH Various types of hip prostheses, (semi- 888.3353 Depuy-Raynham, A Div. Of Uncemented, Metal/polymer, Non- constrained, uncemented, metal/polymer. Depuy Orthopaedics Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH EXACTECH BIPOLAR hip endoprosthesis. 888.3353 Exactech, Inc. Uncemented, Metal/polymer, Non- Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH 888.3353 Implex Corp. Uncemented, Metal/polymer, Non- Porous, Calcium-phophate Prosthesis, Hip, Semi-Constrained, MEH ALFA HA coated total hip system consists of 888.3353 Osteoimplant Technology, Uncemented, Metal/polymer, Non- ALFA modular femoral stems, ALFA modular Inc. Porous, Calcium-phophate acetabular components and an array of fixation screws. Prosthesis, Hip, Semi-Constrained, MEH Sterile ha coated femoral hip stems and 888.3353 Zimmer Trabecular Metal Uncemented, Metal/polymer, Non- cups. Technology Porous, Calcium-phophate Port, Intraosseous, Implanted MHC Automatic injection intraosseous access 880.5570 Waismed Ltd. needle/trocar Catheter, Urological (Antimicrobial) MJC 876.5130 C. R. Bard, Inc., Bard and Accessories Urological Div. Catheter, Urological (Antimicrobial) MJC Staged Guidewire extra stiff guidewire 876.5130 MAQUET and Accessories designed to facilitate sheathless IAB insertion. Sold with True Sheatless insertion kit or separately in boxes of 10 ea. Catheter, Urological (Antimicrobial) MJC FLEXILOG Urodynamic Catheters and 876.5130 Oakfield Instruments Ltd. and Accessories Accesories. A full range of catheters, transducers and pump tube sets. Catheter, Urological (Antimicrobial) MJC Antibacterial foley catheter. 876.5130 Rochester Medical Corp. and Accessories Check Valve, Retrograde Flow (In- MJF 880.5440 B. Braun Oem Division, B. Line) Braun Medical Inc. Check Valve, Retrograde Flow (In- MJF 880.5440 Halkey-Roberts Corp. Line) Check Valve, Retrograde Flow (In- MJF 880.5440 International Medical Line) Industries Check Valve, Retrograde Flow (In- MJF 880.5440 Np Medical, Inc. Line) Check Valve, Retrograde Flow (In- MJF 880.5440 Spirax Sarco, Inc. Line) Check Valve, Retrograde Flow (In- MJF 880.5440 Vernay Laboratories, Inc. Line) CPB Check Valve, Retrograde Flow, MJJ Vent valve. 870.4400 Alliant Healthcare Products In-Line CPB Check Valve, Retrograde Flow, MJJ Retrograde flow valve. 870.4400 Terumo Cardiovascular In-Line Systems (Tcvs) Catheter, Intravascular Occluding, MJN Occluding shunt. 870.4450 Boston Scientific Corp. Temporary

Source: MDRWeb.com 184 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Catheter, Intravascular Occluding, MJN Vessel occluder. 870.4450 Chase Medical, Lp Temporary Catheter, Intravascular Occluding, MJN Peripheral occlusion catheter. 870.4450 Coaxia, Inc. Temporary Catheter, Intravascular Occluding, MJN Occlusion catheter. 870.4450 Edwards Lifesciences Temporary Technology Sarl Catheter, Intravascular Occluding, MJN Occlusion balloon catheter. 870.4450 Ev3 Neurovascular Temporary Catheter, Intravascular Occluding, MJN Sizing catheter. 870.4450 Numed, Inc. Temporary Orthosis, Spondylolisthesis Spinal MNH Pedicle screw system. 888.3070 Abbott Spine, Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH Triplefix system. 888.3070 Advanced Spine Technology, Fixation Inc. Orthosis, Spondylolisthesis Spinal MNH Pedicle screw spinal system. 888.3070 Aesculap Implant Systems, Fixation Inc. Orthosis, Spondylolisthesis Spinal MNH Spinal fixation system. 888.3070 Allez Spine, Llc Fixation Orthosis, Spondylolisthesis Spinal MNH Pedicle screw spinal system. 888.3070 Alphatec Spine, Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH 888.3070 Applied Spine Technologies, Fixation Inc. Orthosis, Spondylolisthesis Spinal MNH Screw/plate system 888.3070 Co-Ligne Ag Fixation Orthosis, Spondylolisthesis Spinal MNH Med pedicle screw. 888.3070 Depuy Spine, Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH CITADEL ANTERIO; GATEWAY 888.3070 Globus Medical Inc. Fixation THORACOLUMBAR PLATE SYSTEM; PROTEX CT CERVICOTHORACIC SPINAL SY; REVERE STABILIZATION SYSTEM; TEM Orthosis, Spondylolisthesis Spinal MNH Multi-axial screw. 888.3070 Medtronic Sofamor Danek Fixation Usa, Inc. Orthosis, Spondylolisthesis Spinal MNH Spinal implants. 888.3070 Nuvasive, Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH Various. 888.3070 Orthotec, Llc Fixation Orthosis, Spondylolisthesis Spinal MNH Pedicle screw system. 888.3070 Spine Wave, Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH Spinal fixation system. 888.3070 Spinecraft Llc Fixation Orthosis, Spondylolisthesis Spinal MNH Various types and sizes of spondylolisthesis 888.3070 Synthes (Usa) Fixation spinal fixation orthoses. Orthosis, Spondylolisthesis Spinal MNH Pedicle screw fixation system. 888.3070 Synthes San Diego Fixation Orthosis, Spondylolisthesis Spinal MNH Spinal fixation device. 888.3070 Ultimate Spine, Llc. Fixation Orthosis, Spondylolisthesis Spinal MNH Pedicle screw fixation system. 888.3070 Us Spine Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH Pedicle screw system. 888.3070 Vertiflex (Tm), Incorporated Fixation Orthosis, Spondylolisthesis Spinal MNH Multi-axial screw. 888.3070 Warsaw Orthopedic, Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH Multiple 888.3070 Wenzel Spine Inc. Fixation Orthosis, Spondylolisthesis Spinal MNH Capless Pedicle Screw System; X90 Pedicle 888.3070 X-Spine Systems, Inc. Fixation Screw System ; Capless Li Pedicle System ; Fortex Pedicle Screw System; Orthosis, Spondylolisthesis Spinal MNH Spondyloisthesis spinal fixation system. 888.3070 Zimmer Spine, Inc. Fixation Orthosis, Spinal Pedicle Fixation MNI Pedicle screw system. 888.3070 Abbott Spine, Inc. Orthosis, Spinal Pedicle Fixation MNI Trifix system. 888.3070 Advanced Spine Technology, Inc.

Source: MDRWeb.com 185 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Orthosis, Spinal Pedicle Fixation MNI Pedicle screw spinal system. 888.3070 Aesculap Implant Systems, Inc. Orthosis, Spinal Pedicle Fixation MNI Spinal fixation system. 888.3070 Allez Spine, Llc Orthosis, Spinal Pedicle Fixation MNI Pedicle screw system. 888.3070 Alphatec Spine, Inc. Orthosis, Spinal Pedicle Fixation MNI Valeo PS 888.3070 Amedica Corporation Orthosis, Spinal Pedicle Fixation MNI Pedicle screw. 888.3070 Depuy Spine, Inc. Orthosis, Spinal Pedicle Fixation MNI PROTEX CT CERVICOTHORACIC SPINAL SY; 888.3070 Globus Medical Inc. REVERE STABILIZATION SYSTEM; TEM Orthosis, Spinal Pedicle Fixation MNI Rod and screw spinal instrumentation. 888.3070 Innovasis, Inc. Orthosis, Spinal Pedicle Fixation MNI Pedicle screw spinal system. 888.3070 Jemo Spine, Llc Orthosis, Spinal Pedicle Fixation MNI Spine fixation system. 888.3070 K2m, Inc. Orthosis, Spinal Pedicle Fixation MNI 888.3070 Lanx Inc. Orthosis, Spinal Pedicle Fixation MNI Pedicle screw fixation. 888.3070 Micron Precision Engineering, Inc. Orthosis, Spinal Pedicle Fixation MNI Custom spinal orthoses. 888.3070 Nick’s Fabrication Incorporatedâ€ž Orthosis, Spinal Pedicle Fixation MNI Spinal implants. 888.3070 Nuvasive, Inc. Orthosis, Spinal Pedicle Fixation MNI Various. 888.3070 Orthotec, Llc Orthosis, Spinal Pedicle Fixation MNI Spine pedicle screw system. 888.3070 Paramount Surgicals, Inc. Orthosis, Spinal Pedicle Fixation MNI Spine pedicle screw system. 888.3070 Pisharodi Surgicals, Inc. Orthosis, Spinal Pedicle Fixation MNI Multiple. 888.3070 Scient’X Usa, Inc. Orthosis, Spinal Pedicle Fixation MNI Pedicle screw spine system. 888.3070 Seaspine Orthosis, Spinal Pedicle Fixation MNI Pedicle screw system. 888.3070 Spine Wave, Inc. Orthosis, Spinal Pedicle Fixation MNI Spinal fixation system. 888.3070 Spinecraft Llc Orthosis, Spinal Pedicle Fixation MNI Various types and sizes of pedicle fixation 888.3070 Synthes (Usa) orthoses. Orthosis, Spinal Pedicle Fixation MNI 888.3070 Theken Spine Llc Orthosis, Spinal Pedicle Fixation MNI 888.3070 Theken Spine, Llc Orthosis, Spinal Pedicle Fixation MNI Pedicle screw system. 888.3070 Us Spine Inc. Orthosis, Spinal Pedicle Fixation MNI Pedicle screw system. 888.3070 Vertebron, Inc. Orthosis, Spinal Pedicle Fixation MNI Pedicle screw system. 888.3070 Vertiflex (Tm), Incorporated Orthosis, Spinal Pedicle Fixation MNI 888.3070 V--Operations Management Consulting, Orthosis, Spinal Pedicle Fixation MNI Capless Pedicle Screw System; X90 Pedicle 888.3070 X-Spine Systems, Inc. Screw System; Capless Li Pedicle System; Fortex Pedicle Screw System; Orthosis, Spinal Pedicle Fixation MNI Spinal pedicle fixation systems. 888.3070 Zimmer Spine, Inc. Staple, Absorbable MNU Staple. 888.3030 Arthrex, Inc. Staple, Absorbable MNU BioScrew 888.3030 ConMed Linvatec Staple, Absorbable MNU 888.3030 Covidien Lp, Formerly Registered As United States Surgical Catheter, Assisted Reproduction MQF 884.6110 Conceptus, Inc. Catheter, Assisted Reproduction MQF 884.6110 Cook Ob/Gyn Catheter, Assisted Reproduction MQF 884.6110 Genx International Catheter, Assisted Reproduction MQF Embryo transfer catheter. 884.6110 Inntec, Inc. Catheter, Assisted Reproduction MQF Embryo transfer catheter 884.6110 Labotect Labor-Technik Gottingen Catheter, Assisted Reproduction MQF 884.6110 Rocket Medical Plc. Spinal Vertebral Body Replacement MQP Vertebral body replacement. 888.3060 Abbott Spine, Inc. Device Spinal Vertebral Body Replacement MQP Vetebral body replacement device. 888.3060 Alphatec Spine, Inc. Device Spinal Vertebral Body Replacement MQP Valeo Spacer System 888.3060 Amedica Corporation Device

Source: MDRWeb.com 186 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Spinal Vertebral Body Replacement MQP Vertebral body replacement. 888.3060 Atlas Spine Inc. Device Spinal Vertebral Body Replacement MQP Stackable cage. 888.3060 Depuy Spine, Inc. Device Spinal Vertebral Body Replacement MQP RETAIN RADIOLUCENT SPACER; XPAND 888.3060 Globus Medical Inc. Device CORPECTOMY SPACER; XPAND RADIOLUCENT CORPECTOMY Spinal Vertebral Body Replacement MQP 888.3060 Implex Corp. Device Spinal Vertebral Body Replacement MQP Vertebral body replacement device. 888.3060 K2m, Inc. Device Spinal Vertebral Body Replacement MQP Vbr system. 888.3060 Lanx Inc. Device Spinal Vertebral Body Replacement MQP Vertebral body replacement device. 888.3060 Nuvasive, Inc. Device Spinal Vertebral Body Replacement MQP Various sizes of vertebral body replacement, 888.3060 Orthovita, Inc. Device vbr devices. Spinal Vertebral Body Replacement MQP Vertebral body replacement. 888.3060 Rkl Technologies, Inc. Device Spinal Vertebral Body Replacement MQP Interplate vbr system. 888.3060 Rsb Spine Llc. Device Spinal Vertebral Body Replacement MQP Vertebral body replacement. 888.3060 Spinal Elements, Inc. Device Spinal Vertebral Body Replacement MQP Vertebral body replacement device. 888.3060 Spine Wave, Inc. Device Spinal Vertebral Body Replacement MQP 888.3060 Spineworks Medical Inc. Device Spinal Vertebral Body Replacement MQP Vertebral body replacement device. 888.3060 Theken Spine Llc Device Spinal Vertebral Body Replacement MQP 888.3060 Theken Spine, Llc Device Spinal Vertebral Body Replacement MQP ENDOSKELETON TA VERTE 888.3060 Titan Spine Llc. Device Spinal Vertebral Body Replacement MQP Titanium mesh. 888.3060 Us Spine Inc. Device Spinal Vertebral Body Replacement MQP Octane 888.3060 Vertiflex (Tm), Incorporated Device Spinal Vertebral Body Replacement MQP Interbody fixator. 888.3060 Warsaw Orthopedic, Inc. Device Spinal Vertebral Body Replacement MQP Calix Spinal Implant System 888.3060 X-Spine Systems, Inc. Device Spinal Vertebral Body Replacement MQP Hedrocel vertebral body replacement. 888.3060 Zimmer Trabecular Metal Device Technology Stent, Colonic, Metalic, Expandable MQR Colorectal stent 878.3610 Angiomed Gmbh & Co. Medizintechnik Kg Stent, Colonic, Metalic, Expandable MQR Colon stent. 878.3610 Cook Endoscopy Filler, Bone Void, Calcium MQV Bone substitute. 888.3045 Arthrex, Inc. Compound Filler, Bone Void, Calcium MQV Various types of bone graft substitute. 888.3045 Biomet, Inc. Compound Filler, Bone Void, Calcium MQV Filler,bone void, calcium compound.; 888.3045 Biostructures, Llc Compound Osteomatrix; Osteomatrix Collagen Scaffold; Interface Bone Void Filler Filler, Bone Void, Calcium MQV Filer,bone void, calciun compound. 888.3045 Collagen Matrix, Inc. Compound Filler, Bone Void, Calcium MQV Bone graft substiture. 888.3045 Depuy Spine, Inc. Compound Filler, Bone Void, Calcium MQV B-tricalcium phosphate. 888.3045 Depuy Spine, Inc. Compound Filler, Bone Void, Calcium MQV Bone void fillers. 888.3045 Integra Spine Compound

Source: MDRWeb.com 187 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Filler, Bone Void, Calcium MQV Bone, void filler. 888.3045 Medtronic Sofamor Danek Compound Usa, Inc. Filler, Bone Void, Calcium MQV Bone void filler containing human 888.3045 Musculoskeletal Transplant Compound demineralized bone matrix. Foundation Filler, Bone Void, Calcium MQV Bone void filler, bone graft substitute. 888.3045 Nanotherapeutics, Inc. Compound Filler, Bone Void, Calcium MQV NovaBone - Synthetic Bone Void Filler; 888.3045 Novabone Products, Llc Compound NovaBone Putty - Bioactive Synthetic Graft Filler, Bone Void, Calcium MQV Bone void filler. 888.3045 Nuvasive, Inc. Compound Filler, Bone Void, Calcium MQV Various sizes and shapes of sterile bone 888.3045 Orthovita, Inc. Compound graft material. Filler, Bone Void, Calcium MQV Filler, bone void, calcium compound. 888.3045 RTI Biologics Inc. Compound Filler, Bone Void, Calcium MQV Bone void filler. 888.3045 Skeletal Kinetics, Llc Compound Filler, Bone Void, Calcium MQV 888.3045 Smith & Nephew Inc.- Compound Orthopaedics Division Filler, Bone Void, Calcium MQV Bone void filler. 888.3045 Spinecraft Llc Compound Filler, Bone Void, Calcium MQV Bone void filler. 888.3045 Synthes (Usa) - Development Compound Center Filler, Bone Void, Calcium MQV 888.3045 Wright Medical Group, Inc. Compound Accessories, Pump, Infusion MRZ AC Adapters for leading syringe and 880.5725 Aiv, Inc. (Formerly American ambulatory pumps. Iv) Accessories, Pump, Infusion MRZ Infusion pump accessories. 880.5725 Cardinal Health 303,Inc. Accessories, Pump, Infusion MRZ Endoscopy pump. 880.5725 Clarus Medical, Llc. Accessories, Pump, Infusion MRZ Dosing calcutor, for glucose, insulin, and 880.5725 Glucotec, Inc. saline. Accessories, Pump, Infusion MRZ Accessories. 880.5725 Integra Lifesciences Corp. Accessories, Pump, Infusion MRZ CareLink USB; ComLink MMT-7304 880.5725 Medtronic Minimed Accessories, Pump, Infusion MRZ Power Infuser 880.5725 Zoll Medical Corp. Rod, Fixation, Intramedullary And NDE Intramedullary femoral nail. 888.3020 Advanced Orthopaedic Accessories, Metallic And Non- Solutions, Inc. collapsible Rod, Fixation, Intramedullary And NDE VERTEX SELECT CHROMALOY Plus Rod 888.3020 Medtronic, Inc. Accessories, Metallic And Non- collapsible Rod, Fixation, Intramedullary And NDE Various types and sizes of intramedullary 888.3020 Zimmer Manufacturing B.V. Accessories, Metallic And Non- nails, pins, and sets containing varis. collapsible Plate, Fixation, Bone, Non-Spinal, NDF Axis, timesh, atlas. 888.3030 Warsaw Orthopedic, Inc. Metallic Plate, Fixation, Bone, Non-Spinal, NDF Various types and sizes of bone plates. 888.3030 Zimmer Manufacturing B.V. Metallic Screw, Fixation, Bone, Non-Spinal, NDJ Bone screw. 888.3040 Advanced Orthopaedic Metallic Solutions, Inc. Screw, Fixation, Bone, Non-Spinal, NDJ Various sizes of cortical screws. 888.3040 Surgical Implant Generation Metallic Network (Sign) Screw, Fixation, Bone, Non-Spinal, NDJ Ucss, atlas. 888.3040 Warsaw Orthopedic, Inc. Metallic Screw, Fixation, Bone, Non-Spinal, NDJ Various types and sizes of bone screws. 888.3040 Zimmer Manufacturing B.V. Metallic Cement, Bone, Vertebroplasty NDN Pmma. 888.3027 Advanced Biomaterial Systems, Inc. Cement, Bone, Vertebroplasty NDN Cement, bone, vertebroplasty. 888.3027 Medtronic Sofamor Danek Usa, Inc. Cement, Bone, Vertebroplasty NDN Sterile polymethylmethacrylate, pmma, 888.3027 Medtronic Spine Llc bone cement.

Source: MDRWeb.com 188 Implant Class II Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Cement, Bone, Vertebroplasty NDN Pmma bone cement. 888.3027 Stryker Instruments, Instruments Div. Cement, Bone, Vertebroplasty NDN Pmma bone cement. 888.3027 Stryker Puerto Rico, Ltd. Anchor, Suture, Bone Fixation, NOV Various types of bone anchors, various 888.3030 C-Axis P.R., Inc. Metallic types of bone fixation. Prosthesis, Knee Patellofemorotibial, NPJ Bicompartmental knee prosthesis. 888.3560 Conformis, Inc. Partial, Semi-constrained, Cemented, Polymer/metal/polymer Posterior Metal/polymer Spinal NQP Pedicle screw system. 888.3070 Synthes San Diego System, Fusion Orthosis, Spine, Plate, Laminoplasty, NQW Orthosis, spine, plate, laminoplasty, metal. 888.3050 Medtronic Puerto Rico Metal Operations Co.,Med Rel Orthosis, Spine, Plate, Laminoplasty, NQW Orthosis, spine, plate, laminoplasty, metal. 888.3050 Medtronic Sofamor Danek Metal Usa, Inc. Orthosis, Spine, Plate, Laminoplasty, NQW Orthosis, spine, plate, laminoplasty, metal. 888.3050 Warsaw Orthopedic, Inc. Metal Cement, Bone, Pre-formed, Modular, OBL Kiva VCF Treatment System 888.3027 Benvenue Medical, Inc. Polymeric, Vertebroplasty Cement, Bone, Vertebroplasty, Pre- OBM SPACE 360 Delivery System; StabiliT Vertebral 888.3027 DFine Inc. formed, Modular Augmentation Sys Cement, Bone, Vertebroplasty, Pre- OBM OsseoPerm 1.0 Bone Cement 888.3027 Osseon Therapeutics, Inc. formed, Modular Intervertebral Fusion Device With ODP Valeo Spacer 888.3080 Amedica Corporation Bone Graft, Cervical Intervertebral Fusion Device With ODP Benvenue IBF Implant System 888.3080 Benvenue Medical, Inc. Bone Graft, Cervical Intervertebral Fusion Device With ODP Newton 888.3080 Binder Biomedical Inc. Bone Graft, Cervical Intervertebral Fusion Device With ODP STALIF C 888.3080 Centinel Spine Inc. Bone Graft, Cervical Intervertebral Fusion Device With ODP 888.3080 Theken Spine, Llc Bone Graft, Cervical Intervertebral Fusion Device With ODP Calix Spinal Implant System 888.3080 X-Spine Systems, Inc. Bone Graft, Cervical

Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Device, Counterpulsating, External DRN External Counterpulsation Device 870.5225 Cardiomedics, Inc. Device, Counterpulsating, External DRN External counter-pulsation device. 870.5225 Ecp Health, Inc. Device, Counterpulsating, External DRN Counterpulastion device. 870.5225 Nicore Equipment & Leasing, Inc. Device, Counterpulsating, External DRN 870.5225 Vasomedical Inc. Ventricular (Assisst) Bypass DSQ Ab-180 css. Cardiac Assist, Inc. Ventricular (Assisst) Bypass DSQ Various G.U. Medical Ltd. Ventricular (Assisst) Bypass DSQ Various sizes of apical left ventricle Medtronic Cardiovascular connectors. Surgery, The Heart Valve Div. Ventricular (Assisst) Bypass DSQ Various sizes. Medtronic Heart Valves Ventricular (Assisst) Bypass DSQ Left ventricular assist device. Micromed Technology, Inc. Ventricular (Assisst) Bypass DSQ Various sizes of mechanical ventricular assist Peter Schiff Enterprise cups. Ventricular (Assisst) Bypass DSQ Total artificial heart. Syncardia Systems, Inc. Ventricular (Assisst) Bypass DSQ The EPAD is a valveless, pneumatically Whalen Biomedical driven cardiac assist device for providing Incorporated short term right or left ventricular support. Ventricular (Assisst) Bypass DSQ World Heart Inc. Ventricular (Assisst) Bypass DSQ Novacor N100 left ventricular assist system. World Heart Inc.

Source: MDRWeb.com 189 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Permanent Pacemaker Electrode DTB 870.3680 Accellent Inc. Permanent Pacemaker Electrode DTB Electrode, pacemaker, permanent. 870.3680 Edwards Lifesciences Technology Sarl Permanent Pacemaker Electrode DTB 870.3680 Ela Medical, Inc. Permanent Pacemaker Electrode DTB Temporary pacing wire/6 product codes. 870.3680 Ethicon, Inc. Permanent Pacemaker Electrode DTB Various implantable grades, properties, 870.3680 Fort Wayne Metals Research and coatings of precision wire for leads, Prod. Corp. including DFT(R) wire and cable. Permanent Pacemaker Electrode DTB 870.3680 Greatbach Medical Permanent Pacemaker Electrode DTB Electrode pacemaker - permanent and 870.3680 Lake Region Manufacturing, temporary. Inc. Permanent Pacemaker Electrode DTB Various models of implantable leads. 870.3680 Maquet Puerto Rico Inc. Permanent Pacemaker Electrode DTB Temporary & permanent cardiac pacing 870.3680 Medtronic Puerto Rico leads. Operations Co., Villalba Permanent Pacemaker Electrode DTB Permanent pacing lead. 870.3680 Oscor, Inc. Permanent Pacemaker Electrode DTB Heart wires. 870.3680 Pace Medical, Inc. Permanent Pacemaker Electrode DTB Permanent pacing lead 870.3680 Somedics Permanent Pacemaker Electrode DTB Unipolar, silicone with sutureless screw-in 870.3680 St. Jude Medical Cardiac electrode. Rhythm Management Div. Permanent Pacemaker Electrode DTB Various models of cardiac pacing leads 870.3680 St. Jude Medical Sweden Ab Permanent Pacemaker Electrode DTB Permanent pacing lead 870.3680 Vascomed Institut Fur Kathetertechnologie Gmbh Pulse-generator, Pacemaker, DTE 870.3600 Apc Medical Ltd. External Pulse-generator, Pacemaker, DTE M30 (SSI temporary pacemaker) 870.3600 Cardiac Impulse S.R.L. External Pulse-generator, Pacemaker, DTE Transesophageal atrial pacing and 870.3600 Cardio Command, Inc. External recording catheter (TAP) and P-wave amplification using TAPSCOPE, esophageal stethoscope; TAPCATH Five-French catheter. Pulse-generator, Pacemaker, DTE 870.3600 Galix Biomedical External Instrumentation, Inc. Pulse-generator, Pacemaker, DTE P203 EXTERNAL PACEMAKER - external 870.3600 Lohmeier Medizin Elektronik External (transthoracic) pacemaker as separate Gmbh & Co. device with Fixed Mode, Demand Mode, and Overdrive setting; including Operation Manual. External pacemaker P203, fixed mode, demand mode, overdrive setting, current supply through Pulse-generator, Pacemaker, DTE No common name listed. 870.3600 Mcpherson Enterprises, Inc. External Pulse-generator, Pacemaker, DTE External, pulse-generator pacemaker. 870.3600 Oscor, Inc. External Pulse-generator, Pacemaker, DTE Temporary cardiac pacemaker. 870.3600 Osypka Medical, Inc. External Pulse-generator, Pacemaker, DTE 5 models: single chamber and dual 870.3600 Pace Medical, Inc. External chamber temporary cardiac pacemakers. Pacing modes cover: AAI, AOO, AAT, VOO, VVI, VVT, DOO, DVI, DDI and DDD, depending on model selected. (Certain models with 450 or 800ppm high rate capability.). Pulse-generator, Pacemaker, DTE STAT-PACE II: Transesophageal cardiac 870.3600 Seecor, Inc. External pacer. STAT-PACE IIA: transesophageal cardiac pacer, OEM. Model 2A, transesophageal cardiac pacer, OEM. Pulse-generator, Pacemaker, DTE Dual-chamber, multi-mode including 870.3600 St. Jude Medical Cardiac External DDD, DVI and DDI, multiprogrammable Rhythm Management Div. parameters with rapid atrial pacing to 800 ppm. Implantable Pacemaker Pulse- DXY Implantable pulse generator. 870.3610 Arizona Device generator Manufacturing Implantable Pacemaker Pulse- DXY Pulse generator, SSS. 870.3610 Boston Scientific Corp. generator

Source: MDRWeb.com 190 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Implantable Pacemaker Pulse- DXY Varsal 12 (SSI-C); Varsal 22 (DDD-C); Varsal 870.3610 Cardiac Impulse S.R.L. generator 32 (VDD-C); Aura S (SSI-C); Aura SI (SSI-C); Aura D (DDD-C); Aura VD (VDD-C) Implantable Pacemaker Pulse- DXY 870.3610 Ela Medical, Inc. generator Implantable Pacemaker Pulse- DXY Pulse generator, sss 870.3610 Guidant Ireland generator Implantable Pacemaker Pulse- DXY Implantable pulse generator. 870.3610 Medtronic Puerto Rico generator Operations Co., Juncos Implantable Pacemaker Pulse- DXY Implantable pulse generator. 870.3610 Medtronic Puerto Rico generator Operations Co.,Med Rel Implantable Pacemaker Pulse- DXY 870.3610 St. Jude Medical Cardiac generator Rhythm Management Div. Implantable Pacemaker Pulse- DXY Various models of pulse generators 870.3610 St. Jude Medical Sweden Ab generator Replacement Heart-valve DYE Storage and preservation (liquid nitrogen) 870.3925 Cryolife, Inc. of human tissue heart valves (pulmonary & aortic). Shipment of valves for implant within 24 hours. Replacement Heart-valve DYE 870.3925 Edwards Lifesciences, Llc. Replacement Heart-valve DYE Various models & sizes of sterile mechanical 870.3925 Medtronic Cardiovascular & porcine bioprostheses & conduits. Surgery, The Heart Valve Div. Replacement Heart-valve DYE Various models. 870.3925 Medtronic Heart Valves Replacement Heart-valve DYE Porcine bioprosthetic heart valve. 870.3925 St. Jude Medical, Inc. Stimulator, Electrical, Implantable, EZW 876.5270 Athena Feminine For Incontinence Technologies, Inc Stimulator, Electrical, Implantable, EZW MINNOVA pelvic floor stimulator for 876.5270 Dedicated Distribution For Incontinence incontinence. Stimulator, Electrical, Implantable, EZW INNOVA home therapy system for 876.5270 Empi, Inc. For Incontinence incontinence. Intervaginal electric stimulation strengthens lax pelvic floor muscles and controls uninhibited detrusor contractions. Stimulator, Electrical, Implantable, EZW Sacral nerve stimulator for voiding 876.5270 Medtronic Puerto Rico For Incontinence dysfunction. Operations Co., Juncos Prosthesis, Testicular FAF Same 876.3750 Combined Instruments (Pvt.), Ltd. Prosthesis, Urethral Sphincter FAG AMS SPHINCTER 800 Urinary Prosthesis. American Medical Systems, Inc. Prosthesis, Urethral Sphincter FAG Sphicterotome. Wilson-Cook Medical, Inc. Cannula, AV Shunt FIQ Full range of shunts and vessel tips including 876.5540 Angiodynamics, Inc. S-300 Series, Allen-Brown, pediatric, and ST- Series with integral tips. Cannula, AV Shunt FIQ Various. 876.5540 Icu Medical (Ut), Inc Prosthesis, Breast, Non-Inflatable, FTR B.I.P. breast-implant protector assists 878.3540 Adept-Med International, Internal, Silicone Gel-filled in preventing implants from nicks and Inc. punctures. Prosthesis, Breast, Non-Inflatable, FTR 878.3540 Mc Ghan Medical S.A. Internal, Silicone Gel-filled Prosthesis, Breast, Non-Inflatable, FTR 878.3540 Mc Ghen Medical S.R.L. Internal, Silicone Gel-filled Prosthesis, Breast, Non-Inflatable, FTR Various types of sterile silicone gel-filled 878.3540 Mentor Texas, Inc. Internal, Silicone Gel-filled breast prostheses. Prosthesis, Breast, Non-Inflatable, FTR Airway Division Post-Mastectomy products. 878.3540 Truform Orthotics & Internal, Silicone Gel-filled Prosthetics Prosthesis, Breast, Inflatable, FWM Saline filled. Silicone gel filled breast 878.3530 Allergan Internal, Saline implants. Prosthesis, Breast, Inflatable, FWM Saline-filled breast implants 878.3530 Mcghan Medico, S.A. Internal, Saline Prosthesis, Breast, Inflatable, FWM Inflatable mammary prostheses. 878.3530 Mentor Texas, Inc. Internal, Saline

Source: MDRWeb.com 191 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Breast, Inflatable, FWM Various 878.3530 Poly Implants Protheses Internal, Saline Prosthesis, Breast, Inflatable, FWM Airway Division Post-Mastectomy products. 878.3530 Truform Orthotics & Internal, Saline Prosthetics Prosthesis, Breast, Inflatable, FWM An all silicone rubber, saline-filled prosthesis 878.3530 Whalen Biomedical Internal, Saline with microporous exterior surfaces to Incorporated minimize fibrous tissue encapsulation. Prosthesis, Arterial Graft, Bovine FZC ARTEGRAFT collagen vascular grafts Artegraft, Inc. Carotid Artery with natural advantages over synthetic. Indications for use include A-V access and peripheral bypass. Outside diameters from 6 to 8mm and lengths up to 52 cm. Stimulator, Intracerebral/ GYZ Electrical brain stimulator (e.b.s.) sterotatic. 882.5840 Avery Biomedical Devices, Subcortical, Implanted Inc. Implanted Cerebellar Stimulator GZA Cerebellar stimulator. 882.5820 Avery Biomedical Devices, Inc. Stimulator, Spinal Cord, Implantable, GZD Micturition stimulator. 882.5850 Avery Biomedical Devices, For Bladder Evacuator Inc. Implanted Diaphragmatic/Phrenic GZE Breathing pacemaker system. 882.5830 Avery Biomedical Devices, Nerve Stimulator Inc. Implanted Diaphragmatic/Phrenic GZE NeuRx Diaphragm Pacing 882.5830 Synapse Biomedical Inc. Nerve Stimulator System(TM); NeuRx DPS(TM Catheter, Intravascular Occluding HBZ Introducers. 882.5150 Clinical Instruments Intl., Inc. Catheter, Intravascular Occluding HBZ Custom micro-catheter design and 882.5150 Diablo Sales & Marketing, manufacturing. Platinum coils or machined Inc. components and drug delivery systems. Catheter, Intravascular Occluding HBZ Occlusion catheter. 882.5150 Edwards Lifesciences Technology Sarl Catheter, Intravascular Occluding HBZ 882.5150 Edwards Lifesciences, Llc. Catheter, Intravascular Occluding HBZ VASCU-FLO silicone balloon carotid shunt. 882.5150 Uresil, Llc Device, Intrauterine, Contraceptive HDT 884.5360 Ortho-Mcneil-Janssen And Introducer Pharmaceuticals, Inc. Device, Intrauterine, Contraceptive HDT 884.5360 Pragoexport And Introducer Prosthesis, Suture, Cerclage HHY Available prethreaded on braided Ethicon, Inc. polyester suture material, 5mm tape. Prosthesis, Suture, Cerclage HHY Polyester fiber stripes. Ethicon, Llc. Intraocular Lens HQL Intraocular lenses. 886.3600 A.M.O. Puerto Rico Manufacturing, Inc Intraocular Lens HQL Intraocular lenses. 886.3600 Abbott Medical Optics Inc. Intraocular Lens HQL 886.3600 Alcon Manufacturing, Ltd. Intraocular Lens HQL From $305 to $405 per unit, available with 886.3600 Allergan ultraviolet blocker. Intraocular Lens HQL 886.3600 Bausch & Lomb Intraocular Lens HQL 886.3600 Bausch & Lomb Surgical Intraocular Lens HQL 886.3600 Bausch & Lomb, Inc. Intraocular Lens HQL Non-sterile intraocular lens for export only. 886.3600 Benz Research And Development Corp. Intraocular Lens HQL Posterior chamber intraocular lens. 886.3600 Ciba Vision Puerto Rico, Inc. Intraocular Lens HQL Aphakic intraocular lens. 886.3600 Cima Technology, Inc. Intraocular Lens HQL Introcular lens. 886.3600 Ellis Ophthalmic Technologies, Inc. Intraocular Lens HQL Single piece, multipiece, hydrophilic acrylic. 886.3600 Eyekon Medical, Inc Intraocular Lens HQL Intraocular lens.; crystalens 886.3600 Eyeonics, Inc. accommodating iol Intraocular Lens HQL 886.3600 Howard Instruments, Inc. Intraocular Lens HQL Lenstec 886.3600 Lenstec Barbados, Inc. Intraocular Lens HQL Intraoculal lens. 886.3600 Medennium, Inc. Intraocular Lens HQL 886.3600 Ocularvision, Inc.

Source: MDRWeb.com 192 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Intraocular Lens HQL 886.3600 Ophtec B.V. Intraocular Lens HQL ARTISAN Myopia lens and ARTISAN 886.3600 Ophtec Usa, Inc. Hyperopia lens. Phakic implants for the correction of high myopia and hyperopia. Intraocular Lens HQL Intraocular lens. 886.3600 Ophthalmic Innovations Intl., Inc. Intraocular Lens HQL $70.00 to $95.00 for full range of A/C & P/C 886.3600 Rayner Intraocular Lenses lenses (single and two piece). Ltd. Intraocular Lens HQL 886.3600 Schwind Eye-Tech-Solutions Intraocular Lens HQL PHAKIC, Implantable Collamer Lens 886.3600 Staar Surgical Co. Intraocular Lens HQL kelman duet implant; teklens ; teklens II 886.3600 Tekia, Inc. Intraocular Lens HQL Posterior chamber intraocular lens. 886.3600 Thinoptx, Inc. Intraocular Lens HQL 886.3600 U.S. Iol, Inc. Intraocular Lens HQL 886.3600 Universal Medical Products Intraocular Lens HQL 886.3600 Vista Optics Prosthesis, Knee, Hinged (Metal- HRZ 888.3480 Bolt Bethel, Llc Metal) Prosthesis, Knee, Hinged (Metal- HRZ 888.3480 Foster Manufacturing Corp. Metal) Prosthesis, Knee, Hinged (Metal- HRZ 888.3480 Stryker Spine Metal) Prosthesis, Knee, Hemi-, Femoral HSA 888.3570 Stryker Spine Prosthesis, Knee, Hemi-, Femoral HSA Medical devices - implants - various types. 888.3570 Usaeroteam Prosthesis, Knee, Hemi-, Femoral HSA 888.3570 Wright Medical Group, Inc. Stimulator, Osteogenesis, Electric, HTM Ebi, Llc Battery-operated, Invasive Prosthesis, Ligament HWF Storage and preservation (liquid nitrogen) Cryolife, Inc. of human tissue ligaments. Shipment of tissue for implant within 24 hrs. Prosthesis, Ligament HWF Lightweight, modular, artificial lower limb Vessa Ltd. system. Prosthesis, Penis, Inflatable JCW 700 ULTREX and 700 ULTREX PLUS Penile 876.3350 American Medical Systems, Prostheses; AMS 700CX, AMS AMBICOR and Inc. AMS 700CXM Inflatable Penile Prostheses. Prosthesis, Penis, Inflatable JCW Various types of vacuum erection devices. 876.3350 V.T.S.,Inc. Prosthesis, Hip, Semi-Constrained JDL Various types of sterile hip components. 888.3320 Biomet, Inc. (Metal Cemented Acetabular Component) Prosthesis, Hip, Semi-Constrained JDL Various types. 888.3320 Depuy Orthopaedics, Inc. (Metal Cemented Acetabular Component) Prosthesis, Hip, Semi-Constrained JDL Various types. 888.3320 Depuy-Raynham, A Div. Of (Metal Cemented Acetabular Depuy Orthopaedics Component) Prosthesis, Hip, Semi-Constrained JDL 888.3320 Implex Corp. (Metal Cemented Acetabular Component) Prosthesis, Hip, Semi-Constrained JDL Various types of polyethyhere cups 888.3320 J.R.I. Mfg., Ltd. (Metal Cemented Acetabular Component) Prosthesis, Hip, Semi-Constrained JDL Total hip bm prothesis 888.3320 Medicalex (Metal Cemented Acetabular Component) Prosthesis, Hip, Semi-Constrained JDL 888.3320 Stryker Spine (Metal Cemented Acetabular Component) Prosthesis, Hip, Semi-Constrained JDL Acetabular cup system. 888.3320 Zimmer Trabecular Metal (Metal Cemented Acetabular Technology Component) Generator, Pulsatile Flow, JOR 870.4320 Jayza Corp. Cardiopulmonary Bypass

Source: MDRWeb.com 193 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Generator, Pulsatile Flow, JOR 870.4320 Medtronic, Inc. Cardiopulmonary Bypass Generator, Pulsatile Flow, JOR 870.4320 Terumo Cardiovascular Cardiopulmonary Bypass Systems, Corp Materials, Repair or Replacement, KFJ Various pacemaker accessories. 870.3710 Maquet Puerto Rico Inc. Pacemaker Materials, Repair or Replacement, KFJ 870.3710 St. Jude Medical Cardiac Pacemaker Rhythm Management Div. Pump, Blood, Cardiopulmonary KFM Impella 2.5; MPC and Power Supply; Quick 870.4360 Abiomed, Inc. Bypass, Non-Roller Type Set-up Kit Pump, Blood, Cardiopulmonary KFM Centrifugal pump 870.4360 Ashitaka Factory Of Terumo Bypass, Non-Roller Type Corporation Pump, Blood, Cardiopulmonary KFM Centrifugal blood pump. 870.4360 Cardiac Assist, Inc. Bypass, Non-Roller Type Pump, Blood, Cardiopulmonary KFM Nonroller-type blood pump. 870.4360 Cardiovention, Inc. Bypass, Non-Roller Type Pump, Blood, Cardiopulmonary KFM Centrifugal blood pump. 870.4360 International Biophysics Corp. Bypass, Non-Roller Type Pump, Blood, Cardiopulmonary KFM Centrifugal pump. 870.4360 Terumo Cardiovascular Bypass, Non-Roller Type Systems (Tcvs) Pump, Blood, Cardiopulmonary KFM Centrifugal pump system: disposable pump 870.4360 Terumo Cardiovascular Bypass, Non-Roller Type head, drive, monitor & mount accessories Systems, Corp with ultrasonic flow meter. Programmer, Pacemaker KRG Orchestra Dedicated Programmer 870.3700 Ela Medical, Inc. Programmer, Pacemaker KRG Various models of pacemaker programmers 870.3700 St. Jude Medical Sweden Ab Programmer, Pacemaker KRG Various types of non-sterile pulse generator 870.3700 Trivirix International Inc. controllers. Metal Cemented Constrained KRN 888.3480 Implex Corp. Femorotibial Knee Prosthesis Prosthesis, Knee, Patello/ KRP Prous Coated Fined Tibial Tray Comp 888.3550 Exactech, Inc. femorotibial, Constrained, Cemented, Polymer/Metal/Metal Prosthesis, Knee, Patello/ KRP 888.3550 Wright Medical Group, Inc. femorotibial, Constrained, Cemented, Polymer/Metal/Metal Prosthesis, Knee, Patello/ KRP $3,750.00 for cemented APS-type. 888.3550 Sulzer Ortopadie Ltd femorotibial, Constrained, Cemented, Polymer/Metal/Metal Prosthesis, Hip, Semi-Constrained KWA Baumer femoral head 888.3330 Baumer S.A. (Metal Uncemented Acetabular Component) Prosthesis, Hip, Semi-Constrained KWA Various types of hip prosthesis for sterile & 888.3330 Biomet, Inc. (Metal Uncemented Acetabular non-sterile. Component) Prosthesis, Hip, Semi-Constrained KWA Bio-technology porous coated acetabular 888.3330 Bio-Technology Usa, Inc. (Metal Uncemented Acetabular cup hip. Component) Prosthesis, Hip, Semi-Constrained KWA Metasul Acetabular system (metal-metal). 888.3330 Centerpulse Orthopedics Inc. (Metal Uncemented Acetabular Component) Prosthesis, Hip, Semi-Constrained KWA Freeman Cup, Freeman Metal Rack Cup, 888.3330 Corin Group Limited (Metal Uncemented Acetabular SLF Cup, Rotolok Cup, C-Fit Cup, DC - FIT Component) Cup Prosthesis, Hip, Semi-Constrained KWA Uncemented acetabular cup 888.3330 Depuy Bioland (Metal Uncemented Acetabular Component) Prosthesis, Hip, Semi-Constrained KWA Acetabular cup components 888.3330 Depuy France S.A. (Metal Uncemented Acetabular Component) Prosthesis, Hip, Semi-Constrained KWA Various types of uncemented semi- 888.3330 Depuy Orthopaedics, Inc. (Metal Uncemented Acetabular constrained metal acetabular hip prosthesis Component) com.

Source: MDRWeb.com 194 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Semi-Constrained KWA Various types of uncemented semi- 888.3330 Depuy-Raynham, A Div. Of (Metal Uncemented Acetabular constrained metal acetabular hip prosthesis Depuy Orthopaedics Component) com. Prosthesis, Hip, Semi-Constrained KWA CONSENSUS HIP SYSTEM, CoCR, titanium, 888.3330 Hayes Medical, Inc. (Metal Uncemented Acetabular porous, non-porous, collared, non-collared Component) or HA coated stems. Prosthesis, Hip, Semi-Constrained KWA Various styles of acetabuler coated aps 888.3330 J.R.I. Mfg., Ltd. (Metal Uncemented Acetabular Component) Prosthesis, Hip, Semi-Constrained KWA Artificial hip replacement system. 888.3330 Stelkast Company (Metal Uncemented Acetabular Component) Prosthesis, Hip, Hemi-, Acetabular, KWB Cemented acetabular cups 888.3370 Depuy France S.A. Cemented, Metal Prosthesis, Hip, Hemi-, Acetabular, KWB Buechel-pappas acetabular bearing insert. 888.3370 Endotec, Inc. Cemented, Metal Prosthesis, Hip, Hemi-, Acetabular, KWB 888.3370 Zimmer Holdings, Inc. Cemented, Metal Prosthesis, Finger, Constrained, KWG Various 888.3220 Depuy France S.A. Metal/Polymer Prosthesis, Finger, Constrained, KWG Finger joint metal/polymer constrained 888.3220 Small Bone Innovations, Inc. Metal/Polymer cemented prosthesis. Prosthesis, Shoulder, Constrained, KWR Various types of sterile and non-sterile total 888.3640 Biomet, Inc. Metal/Metal or Metal/Polymer shoulders. Cemented Prosthesis, Shoulder, Constrained, KWR 888.3640 Smith & Nephew Inc.- Metal/Metal or Metal/Polymer Orthopaedics Division Cemented Prosthesis, Ankle, Cemented, Non- KXC Buechel-pappas custom total ankle, 888.3120 Endotec, Inc. Constrained bearing & talar component. Prosthesis, Hip, Constrained, Metal KXD EXACTECH AcuMatch C-Series Cemented 888.3300 Exactech, Inc. Total Hip System and EXACTECH AcuMatch A-Series Total Hip System. Prosthesis, Hip, Constrained, Metal KXD OSTEONICS hip prosthesis. 888.3300 Stryker Australia Metallic Cemented Glenoid Hemi- KYM 888.3680 DJO Surgical Shoulder Prosthesis Metallic Cemented Glenoid Hemi- KYM Buechel-pappas glenoid fixation cup. 888.3680 Endotec, Inc. Shoulder Prosthesis Catheter, Subclavian LFJ Dual and single lumen acute care, and 876.5540 Angiodynamics, Inc. dual lumen chronic silicone catheters in varying styles and lengths. Catheter, Subclavian LFJ 876.5540 Arrow International, Inc. Catheter, Subclavian LFJ Dual lumen dialysis/homofiltration catheter. 876.5540 Cardiomed Supplies Inc. Catheter, Subclavian LFJ 876.5540 Hospira, Inc. Stimulator, Spinal-cord, Totally LGW Spinal cord stimulator. Boston Scientific Implanted for Pain Relief Neuromodulation Corporation Stimulator, Cerebellar, Full Implant LGW Various types of sterile and non-sterile spinal Medtronic Puerto Rico (Pain Relief) cord stimulation systems. Operations Co., Juncos Stimulator, Cerebellar, Full Implant LGW Various types of sterile and non-sterile spinal Medtronic Puerto Rico (Pain Relief) cord stimulation systems. Operations Co., Villalba Monitor, Intracranial Pressure, LII Hummingbird Parenchyma - ICP monitor Innerspace, Inc. Implanted Pump, Infusion, Implanted, LKK Arrow International, Inc. Programmable Pump, Infusion, Implanted, LKK Dma Med-Chem Programmable Corporation Pump, Infusion, Implanted, LKK Implantable infusion system. Medtronic Neuromodulation Programmable Pump, Infusion, Implanted, LKK Implantable drug pump. Medtronic Puerto Rico Programmable Operations Co., Juncos Pump, Infusion, Implanted, LKK SYNCHROMED. Medtronic, Inc. Programmable

Source: MDRWeb.com 195 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Pump, Infusion, Implanted, LKK Implantable programmable infusion pump. Proven Process Medical Programmable Devices, Inc. Pump, Infusion, Implanted, LKK Implantable infusion system. Trivirix International Inc. Programmable Catheter, Sampling, Chorionic Villus LLX Rocket Medical Plc. Implant, Dermal, For Aesthetic Use LMH C. R. Bard, Inc., Bard Urological Div. Implant, Dermal, For Aesthetic Use LMH Laresse Fziomed, Inc. Implant, Dermal, For Aesthetic Use LMH Implant, dermal for aesthetic use. Genzyme Corporation Implant, Dermal, For Aesthetic Use LMH ArteFill; Bellafill Suneva Medical, Inc. Implant, Dermal, For Aesthetic Use LMH Uroplasty, Inc. Implant, Collagen For Non-Aesthetic LMI C. R. Bard, Inc., Bard Use Urological Div. Implant, Collagen For Non-Aesthetic LMI Dissolvable lacrimal plug. Lacrimedics, Inc. Use Implant, Collagen For Non-Aesthetic LMI Tipp Machine & Tool, Inc. Use Ceramics, Calcium Triphosphate/ LMN Various types and sizes of hydroxypatite Gyrus Ent L.L.C., Sub. Of Hydroxyapatite, Non-Load Bearing blocks. Gyrus Acmi, Inc. Uses Stimulator, Bone Growth, Non- LOF ORTHOLOGIC 1000 Capstone Therapeutics Invasive Stimulator, Bone Growth, Non- LOF Smith & Nephew Inc.- Invasive Orthopaedics Division Catheter, Balloon For Retinal LOG Howard Instruments, Inc. Reattachment Artificial Heart LOZ Implantable. Abiomed, Inc. Prosthesis, Hip, Semi-Constrained, LPF Ceramic head component. Biomet, Inc. Metal/Ceramic/Ceramic, Cemented Prosthesis, Hip, Semi-Constrained, LPF Bio-technology femoral head, hip, ceramic- Bio-Technology Usa, Inc. Metal/Ceramic/Ceramic, zirconium. Cemented Prosthesis, Hip, Semi-Constrained, LPF Signal Medical Corp. Metal/Ceramic/Ceramic, Cemented Prosthesis, Hip, Semi-Constrained, LPF Ceramic hip ball Societe Des Ceramiques Metal/Ceramic/Ceramic, Techniques Cemented Implant, Corneal, Refractive LQE Addition Technology, Inc. Implant, Corneal, Refractive LQE Vue+ Revision Optics Implant, Corneal, Refractive LQE Vista Optics Spacer, Cement LTO Various types of cement spacers. 888.3320 Depuy Orthopaedics, Inc. Spacer, Cement LTO Various types of cement spacers. 888.3320 Depuy-Raynham, A Div. Of Depuy Orthopaedics Stimulator, Functional LWB Clincial and home rehabilitional DJO Surgical Neuromuscular, Scoliosis electrotheraphy devices, including electrical stimulation, NMES, TENS, clinical ultrasound, laser technologies Stimulator, Functional LWB Copes scopliosis brace. Stars Neuromuscular, Scoliosis Pulse-Generator, Single Chamber, LWO Pulse generator, DR, SR. Boston Scientific Corp. Sensor Driven, Implantable Pulse-Generator, Single Chamber, LWO Pulse generator, dr, sr Guidant Ireland Sensor Driven, Implantable Implantable Pulse Generator, LWP Pulse generator, DDD. Boston Scientific Corp. Pacemaker (Non-crt) Implantable Pulse Generator, LWP Pulse generator, ddd Guidant Ireland Pacemaker (Non-crt) Implantable Pulse Generator, LWP Pulse generator,dual chamber. Medtronic Puerto Rico Pacemaker (Non-crt) Operations Co., Juncos

Source: MDRWeb.com 196 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Heart-Valve, Mechanical LWQ ATS Open Pivot Mechanical Heart Valve ATS Medical, Inc. Heart-Valve, Mechanical LWQ Cryolife-Ross stentless porcine heart valve. Cryolife, Inc. Heart-Valve, Mechanical LWQ Edwards Lifesciences, Llc. Heart-Valve, Mechanical LWQ Medtronic, Inc. Heart-Valve, Mechanical LWQ On-X Ascending Aortic Prosthesis (AAP) with On-X Life Technologies, Inc. the Vascutek Gelweave Valsalva Graft Heart-Valve, Mechanical LWQ Plastic And Metal Center, Inc. Heart-Valve, Mechanical LWQ St. Jude Medical, Inc. Heart-Valve, Non-allograft Tissue LWR Heart valve, tissue. Alabama Tissue Center, Inc. Heart-Valve, Non-allograft Tissue LWR Ats Medical, Inc. Heart-Valve, Non-allograft Tissue LWR Bio Breeders, Inc. Heart-Valve, Non-allograft Tissue LWR Cryolife, Inc. Heart-Valve, Non-allograft Tissue LWR Edwards Lifesciences, Llc. Heart-Valve, Non-allograft Tissue LWR Various models and sizes of porcine Medtronic Cardiovascular bioprostheses and conduits. Surgery, The Heart Valve Div. Heart-Valve, Non-allograft Tissue LWR Overseas Medical Supplies (Uk) Ltd Heart-Valve, Non-allograft Tissue LWR Aortic valve; pulmonic valve. RTI Biologics Inc. Heart-Valve, Non-allograft Tissue LWR Trifecta aortic stented tissue valve St. Jude Medical, Inc. Implantable Cardioverter LWS Implantable cardioverter defibrillator. Arizona Device Defibrillator (Non-crt) Manufacturing Implantable Cardioverter LWS VARIOUS MODELS OF CRT-DS Biotronik, Inc. Defibrillator (Non-crt) Implantable Cardioverter LWS Alto 2 is a dual-chamber rate responsive Ela Medical, Inc. Defibrillator (Non-crt) ICD with a unique PARAD/PARAD+ al;gorithm allowing pacing in the slow VT zone Implantable Cardioverter LWS Various models of aicds. Maquet Puerto Rico Inc. Defibrillator (Non-crt) Implantable Cardioverter LWS Implantable cardioverter defibrillator. Medtronic Puerto Rico Defibrillator (Non-crt) Operations Co., Juncos Implantable Cardioverter LWS Implantable cardioverter defibrillator. Medtronic Puerto Rico Defibrillator (Non-crt) Operations Co.,Med Rel Implantable Cardioverter LWS JEWEL, JEWEL CD, JEWEL PCD, PCD. Medtronic, Inc. Defibrillator (Non-crt) Joint, Temporomandibular, Implant LZD Joint, temporomandibular, implant, dental. 872.3940 Biomet Microfixation Inc. Joint, Temporomandibular, Implant LZD Fossa Eminence Prosthesis. 872.3940 Tmj Implants, Inc. Joint, Temporomandibular, Implant LZD Tmj implant. 872.3940 Tmj Solution, Inc Catheter, Percutaneous MAD Boston Scientific - Maple (Valvuloplasty) Grove Catheter, Percutaneous MAD Cardio-Nef, S.A. De C.V. (Valvuloplasty) Catheter, Percutaneous MAD Numed, Inc. (Valvuloplasty) Catheter, Percutaneous MAD INOUE-BALLOON percutaneous mitral Toray International America (Valvuloplasty) valvuloplasty catheter (PTMC). Inc. Stent, Coronary MAF Sterile single use coronary stent. Abbott Vascular, Cardiac Therapies Stent, Coronary MAF Sterile single use coronary stent. Abbott Vascular, Cardiac Therapies Stent, Coronary MAF Sesame covered stent system. Advanced Bio Prosthetic Surfaces, Ltd Stent, Coronary MAF Various models of sterile coronary stent & Advanced Stent delivery systems. Technologies Stent, Coronary MAF Atrium Flyer Coronary Stent. Atrium Medical Corp. Stent, Coronary MAF Coronary stent. Avantec Vascular Corp.

Source: MDRWeb.com 197 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Stent, Coronary MAF Matrix Drug-Eluting Stent featuring Biosensors International - Usa Biolimus A-9 anti-restenotic compound (investigational device, not for sale); S-Stent Coronary Stent Delivery System (not available for sale in US). Stent, Coronary MAF Stents-various types. Bolton Medical, Inc. Stent, Coronary MAF Coronary stent. Boston Scientific - Marina Bay Customer Fulfillment Center Stent, Coronary MAF WALLSTENT for peripheral use. Boston Scientific Corp. Stent, Coronary MAF Coronary stent Boston Scientific Ireland, Ltd. Stent, Coronary MAF Cardio-Nef, S.A. De C.V. Stent, Coronary MAF Micro-abrasive blasting equipment for Comco, Inc. deburring, cleaning, and material removal on stents, pacemakers, cannula, IV components, and other medical devices. Stent, Coronary MAF Cook Inc. Stent, Coronary MAF Drug eluting stent. Cordis Corporation Stent, Coronary MAF Sterile stents. Cordis Llc Stent, Coronary MAF Various modles of axxess stent system. Devax, Inc. Stent, Coronary MAF Drg International, Inc. Stent, Coronary MAF Coronary stent. Insitu Technologies, Inc. Stent, Coronary MAF M & I Medical Sales, Inc. Stent, Coronary MAF Maxcor Inc Stent, Coronary MAF Medtronic, Inc. Stent, Coronary MAF Stent, stent delivery system. Orbusneich Medical, Inc. Stent, Coronary MAF Svelte Medical Systems Inc. Stent, Coronary MAF Intravascular stent with delivery system. Thermopeutix Inc. Stent, Coronary MAF Tryton Side Branch Stent System Tryton Medical, Inc. Stent, Coronary MAF Coronary stent. Xtent, Incorporated Prosthesis, Knee, Patello/ MBD Patellar knee. Bio-Technology Usa, Inc. Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Fastener, Fixation, Biodegradable, MBJ Various types of biodegradable hard tissue Depuy Orthopaedics, Inc. Hard Tissue fixation fasteners. Fastener, Fixation, Biodegradable, MBJ Various types of biodegradable hard tissue Depuy-Raynham, A Div. Of Hard Tissue fixation fasteners. Depuy Orthopaedics Pump, Vacuum, Electric, Suction- MCJ Facial treatment and cleansing skin, S.O.R. Internacional, S.A. Type Electrode stimulation, muscle toning Pump, Vacuum, Electric, Suction- MCJ Varian Vacuum Products Type Electrode Implant, Cochlear MCM Cochlear implant. Advanced Bionics Corp. Implant, Cochlear MCM Nucleus Freedom cochlear implant system Cochlear Americas consisting of the Nucleus Freedom Contour Advance implant, Freedom ear level and bodyworn speech processors. Implant, Cochlear MCM Jedmed Instruments Co. Spinal Pedicle Screw, Fixation, MCV Screw pedicular system, fixation. Bio-Technology Usa, Inc. Appliance System Spinal Pedicle Screw, Fixation, MCV Merlyn Pharmaceuticals, Inc. Appliance System Spinal Pedicle Screw, Fixation, MCV Multiple and various. Millstone Medical Appliance System Outsourcing Spinal Pedicle Screw, Fixation, MCV CONTOUR Spine System; Pedicle Screw Ortho Development Corp. Appliance System fixation for lumbar spinal fusion. ENVISION Anterior Cervical Plate; one-step locking mechanism, self-drilling screws, large graft window. IBS Allograft; Interbody spacer with C-TLIF procedure, one-piece femoral cortica

Source: MDRWeb.com 198 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Spinal Pedicle Screw, Fixation, MCV Pedicle screw fixation system. Orthopedic Sciences, Inc Appliance System Catheter, Coronary, Atherectomy MCX Coronary atherectomy catheter. Abbott Vascular, Cardiac Therapies Catheter, Coronary, Atherectomy MCX Rotational angioplasty system guide wires. Boston Scientific - Marina Bay Customer Fulfillment Center Catheter, Coronary, Atherectomy MCX Rotablator console. Boston Scientific- Neurovascular Catheter, Coronary, Atherectomy MCX Angiojet Ultra Thrombectomy Console Minnetronix Inc. Device, Removal, Pacemaker MFA LIBERATOR Locking Stylet - Universal Cook Vascular, Incorporated Electrode, Percutaneous locking stylet used during the removal of transvenous cardiac leads. Packaged individually. Device, Removal, Pacemaker MFA Laser-assisted pacemaker lead removal Spectranetics Corp. Electrode, Percutaneous device. Laser sheath designed to thread over an implanted pacing lead and ablate through scar tissue, thereby aiding in the extraction of the pacing lead. Stimulator, Electrical, Implanted For MHY Deep brain stimulator for tremor Medtronic Neuromodulation Parkinsonian Tremor suppression. Stimulator, Electrical, Implanted For MHY Deep brain stimulator for tremor supression. Medtronic Puerto Rico Parkinsonian Tremor Operations Co., Villalba Stimulator, Electrical, Implanted For MHY Deep brain stimulator for tremor supression. Medtronic Puerto Rico Parkinsonian Tremor Operations Co.,Med Rel Stimulator, Electrical, Implanted For MHY Deep brain stimulator for tremor Trivirix International Inc. Parkinsonian Tremor suppression. Heart-Valve, Allograft MIE Aortic human allograft heart valve/ Alabama Tissue Center, Inc. pulmonary human allograft heart valve. Heart-Valve, Allograft MIE Heart valve. American Red Cross National Tissue Services Heart-Valve, Allograft MIE CRYOVALVE cryopreserved allograft human Cryolife, Inc. heart valve. Implanted Fecal Incontinence MIP Uroplasty, Inc. Device Shunt, Portosystemic, Endoprosthesis MIR Tips endoprosthesis. W.L. Gore & Associates,Inc Prosthesis, Intervertebral Disc MJO Intervertebral disc prosthesis with related Depuy Spine, Inc. instrumentation. Prosthesis, Intervertebral Disc MJO Implex Corp. Prosthesis, Intervertebral Disc MJO Intervertebral disc prosthesis. Medtronic Sofamor Danek Usa, Inc. Prosthesis, Intervertebral Disc MJO Total artificial disc. Spinal Kinetics, Inc. Prosthesis, Intervertebral Disc MJO Trimedyne, Inc. Prosthesis, Intervertebral Disc MJO Intervertebral disc prosthesis. Warsaw Orthopedic, Inc. Prosthesis, Shoulder, Humeral MJT Various types of shoulder prostheses. Biomet, Inc. (Bipolar Hemi-shoulder) Metal/ polymer, Cemented or Uncemented Catheter, Balloon, Transcervical MKN Conceptus, Inc. Interarticular Disc Prosthesis MPJ Freedom Lumbar Disc 872.3970 AxioMed Spine Corporation (Interpositional Implant) Mandibular Condyle Prosthesis MPL Condyle implant. 872.3960 Biomet Microfixation Inc. Prosthetic Disc Nucleus Device MQO Same. Raymedica, Llc Prosthesis, Hip, Semi-constrained, MRA Fermoral heads materials, Metals, Alumina, Alceram Tech Inc Metal/Ceramic/Ceramic/Metal, & Zirconia. Heads made for special Cemented Or Uncemented requirements. Prosthesis, Hip, Semi-constrained, MRA Hip prosthesis. Biomet, Inc. Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Prosthesis, Hip, Semi-constrained, MRA Various types of semi-constrained,metal Depuy Orthopaedics, Inc. Metal/Ceramic/Ceramic/Metal, ceramic,ceramic metal,cemented or Cemented Or Uncemented unceme.

Source: MDRWeb.com 199 Implant Class III Devices — General Controls — 510(k)

Product name Product code Product description Regulation number Company name Prosthesis, Hip, Semi-constrained, MRA Truncal orthosis. Tytex, Inc. Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented Catheter, Hemodialysis, Implanted MSD Ash Advance Hemodialysis Catheter a; 876.5540 Ash Access Technology Inc. Centros Catheter, Hemodialysis, Implanted MSD Dialysis catheters and dialysis catheter kits.; 876.5540 Navilyst Medical MULTIPLE Filler, Recombinant Human Bone NEK Collagen sponge. Medtronic Sofamor Danek Morphogenetic Protein, Collagen Usa, Inc. Scaffold With Metal Prosthesis, Osteoinduction Prosthesis, Knee, NJL Various types of knee prosthesis. Biomet, Inc. Patellofemorotibial, Semi- constrained, Metal/polymer, Mobile Bearing Prosthesis, Knee, NJL Various types of patellofemorotibial, semi- Depuy Orthopaedics, Inc. Patellofemorotibial, Semi- constrained, metal/polymer mobile bea. constrained, Metal/polymer, Mobile Bearing Prosthesis, Knee, NJL Various types of patellofemorotibial, semi- Depuy-Raynham, A Div. Of Patellofemorotibial, Semi- constrained, metal/polymer mobile bea. Depuy Orthopaedics constrained, Metal/polymer, Mobile Bearing Orthosis, Spinal Pedicle Fixation, For NKB Pedicle screw system. 888.3070 Abbott Spine, Inc. Degenerative Disc Disease Orthosis, Spinal Pedicle Fixation, For NKB Spinal fixation system. 888.3070 Allez Spine, Llc Degenerative Disc Disease Orthosis, Spinal Pedicle Fixation, For NKB Valeo PS 888.3070 Amedica Corporation Degenerative Disc Disease Orthosis, Spinal Pedicle Fixation, For NKB STABILIMAX BAR SPINAL FUSION SYSTEM 888.3070 Applied Spine Technologies, Degenerative Disc Disease Inc. Orthosis, Spinal Pedicle Fixation, For NKB Metallic bone fixation device. 888.3070 Medtronic Sofamor Danek Degenerative Disc Disease Usa, Inc. Orthosis, Spinal Pedicle Fixation, For NKB Pedicle screw system. 888.3070 Vertiflex (Tm), Incorporated Degenerative Disc Disease Orthosis, Spinal Pedicle Fixation, For NKB Metallic bone fixation device. 888.3070 Warsaw Orthopedic, Inc. Degenerative Disc Disease Orthosis, Spinal Pedicle Fixation, For NKB Pedicle screw system. 888.3070 Zimmer Spine, Inc. Degenerative Disc Disease

Implant Device Companies

(Ems Sa) Electro Medical Systems 3m Company A.M. Surgical, Inc. Ch. De La Vuarpillière 31 601 22nd Ave. South 290 East Main Street, Suite 200 Nyon, 1260, Switzerland Brookings, SD 57006, United States Smithtown, NY 11787, United States Phone: 214-690-8382 Phone: 651-733-4365 Phone: 800-437-9653 Fax: 631-980-4369 3d Medical Concepts, Llc A Plus Dental Lab Email: [email protected] 1061 Morgan Park Rd. 1700 Horizon Drive, --suite 104 Website: www.amsurgical.com Pelham, AL 35124, United States Chalfont, PA 18914, United States Year established: 1995 Phone: 205-987-0935 Phone: 215-996-4177 A.M.G. Medical, Inc. 3m Co. A&A Orthopedics, Incorporated 8505 Dalton Rd. 3M Center 12250 Sw 129th Court, Bldg. 01 Montreal, QUE H4T-IV5, Canada St. Paul, MN 55144-1000, United States Miami, FL 33186, United States Phone: 514-737-5251 Phone: 612-733-1110 Phone: 757-224-0177 Fax: 514-737-6572 Fax: 888-364-3577 Email: [email protected] Email: [email protected] A. Hussain Surgical Corp. Website: www.amgmedical.com Website: www.3m.com Daska Rd. , Haji Pura Year established: 1902 Sialkot, 22161, Pakistan A.M.O. Puerto Rico Manufacturing, Inc Phone: 432-554-4362 Rd. 402, Km. 4.2 3M Company Anasco, PR 00610, United States 5801 Mariemont Ave. Phone: 714-247-8656 Cincinnati, OH 45227-, United States Phone: 513-272-5000 A.T. Medical Gmbh Fax: 513-272-5072 Seidlerstr. 2 Email: [email protected] Rottenburg, 72108, Germany Year established: 1930 Phone: 49-746-11474 Source: MDRWeb.com 200 Abbott Diabetes Care Inc. Able Brothers Acme-Monaco Corp. 1360 South Loop Rd. Roras Rd. East, New Mainapura 75 Winchell Drive Alameda, CA 94502, United States Sialkot-4, Pakistan New Britain, CT 06052-1017, United States Phone: 510-749-5400 Phone: 92-432-55426 Phone: 860-224-1349 Website: www.abbott.com Email: [email protected] Year established: 1888 Ac Healthcare Supply, Inc. Website: www.acmemonaco.com 116-51 230th St. Year established: 1947 Abbott Diagnostics Intl, Biotechnology Ltd Cambria Heights, NY 11411, United States Road #2 KM. 58.0 , PO Box 278, Cruce Davila Phone: 905-448-4706 Acor Orthopaedic, Inc. Barceloneta, PR 00617, United States 18530 South Miles Pkwy. Phone: 787-846-3500 Accelerated Care Plus Corp. Cleveland, OH 44128-4238, United States Email: [email protected] 4850 Joule Street, Suite A-1 Phone: 216-662-4500 Website: www.abbott.com Reno, NV 89502, United States Website: www.acor.com Phone: 775-685-4000 Abbott Laboratories Fax: 775-685-4013 Acorn Equipment Co. Ltd. 100 Abbott Park Rd. Email: [email protected] 53 Old Church Lane Abbott Park, IL 60064-3500, United States Website: www.acplus.com Stanmore, HA7 2RG, United Kingdom Phone: 847-937-6100 Phone: 020 8385 7501 Fax: 800-223-2064 Accellent El Paso Email: [email protected] Email: [email protected] 31C Butterfield Trail Website: www.acorn-equipment.com Website: www.abbott.com El Paso, TX 79906, United States Year established: 1888 Phone: 915-771-9112 Acumar Technology Fax: 915-771-9107 1314 Sw 57th Ave, Portland, OR 97221, United States Abbott Laboratories Email: [email protected] Phone: 503-292-7137 1033 Kingsmill Pkwy. Website: www.accellent.com Columbus, OH 43229, United States Acumed Llc Phone: 614-624-7677 Accellent Inc. 5885 Nw Cornelius Pass Rd. Fax: 800-624-7677 100 Fordham Road Hillsboro, OR 97124, United States Website: www.ross.com Wilmington, MA 01887, United States Phone: 503-627-9957 Phone: 978-570-6900 Abbott Medical Optics Inc. Fax: 978-657-0878 Acumen Medical, Inc. 1700 East St. Andrew Pl. Email: [email protected] 275 Santa Ana Court Santa Ana, CA 92705, United States Website: www.accellent.com Sunnyvale, CA 94085, United States Phone: 714-247-8200 Phone: 408-530-1810 Fax: 866-427-8477 Accellent Inc. Website: www.amo-inc.com 5000 Independence St. Acute Innovations Llc Arvada, CO 80002, United States 21421 Nw Jacobson Rd., Suite 700 Abbott Spine, Inc. Phone: 303-424-7300 Hillsboro, OR 97124, United States 12708 Riata Vista Circle, Suite B-100 Email: [email protected] Phone: 503-627-9957 Austin, TX 78727, United States Website: www.accellent.com Phone: 847-937-6100 Addition Technology, Inc. Email: [email protected] Access Llc 950 Lee St., Ste. 210 Website: us.abbottspine.com 11 West End Rd. Des Plaines, IL 60016, United States Totowa, NJ 07512, United States Phone: 847-297-8419 Abbott Vascular Inc. Phone: 800-973-0355 Email: [email protected] 400 Saginaw Drive Website: www.IntacsFor Keratoconus.com Redwood City, CA 94063-4749, United States Access Scientific Inc. Year established: 2001 Phone: 650-474-3000 12526 High Bluff Drive, Suite 360 Fax: 800-227-9902 San Diego, CA 92130, United States Addto, Inc. Email: [email protected] Phone: 858-259-8333 816 N. Kostner Ave. Website: www.abbottvascular.com Fax: 866-608-8333 Chicago, IL 60651-3423, United States Year established: 1888 Email: [email protected] Phone: 773-278-0294 Website: www.the-wand.com Email: [email protected] Abbott Vascular, Cardiac Therapies Year established: 1972 3200 Lakeside Dr. Accu-Measure, Llc Santa Clara, CA 95054-2807, United States P.O. Box 4411 Adept-Med International, Inc. Phone: 408-845-3000 Englewood, CO 80155-4411, United States 665 Pleasant Valley Rd. Fax: 800-227-9902 Phone: 303-799-4721 Diamond Springs, CA 95619, United States Email: [email protected] Fax: 303-799-4778 Phone: 530-621-1220 Website: www.abbottvascular.com Email: [email protected] Fax: 800-222-8445 Year established: 1888 Website: www.accumeasurefitness.com Email: [email protected] Website: www.adeptmed.com Abbott Vascular, Cardiac Therapies Accuray Surgicals, Ltd. Year established: 1973 26531 Ynez Rd., Mailing P.O. Box 9018 Sarwar Shaheed Rd.,, Lakson Square Bldg. #2 Temecula, CA 92589-9018, United States Karachi, Pakistan Advanced Aesthetic Solutions Phone: 847-937-7988 Phone: 92-212-56864 631 B/c Keeaumoku St. Fax: 800-227-9902 Honolulu, HI 96814, United States Email: [email protected] Accutome, Inc. Phone: 757-224-0177 Website: www.abbottvascular.com 3222 Phoenixville Pike Year established: 1888 Malvern, PA 19355, United States Advanced Bio Prosthetic Surfaces, Ltd Phone: 610-889-0200 4778 Research Dr. Abbott Vascular, Vascular Solutions San Antonio, TX 78240, United States 26531 Ynez Rd., Temecula, CA 92589, United States Aci Medical, Inc. Phone: 210-696-5300 Phone: 847-937-6100 1857 Diamond St. Fax: 800-227-9902 San Marcos, CA 92078-5129, United States Advanced Biomaterial Systems, Inc. Email: [email protected] Phone: 760-744-4400 100 Passaic Ave. Website: www.abbottvascular.com Fax: 760-744-4401 Chatham, NJ 07928, United States Email: [email protected] Phone: 973-635-9040 Abiomed, Inc. Website: www.acimedical.com 22 Cherry Hill Dr. Year established: 1984 Advanced Biomedical Devices, Inc. (Abd, Inc.) Danvers, MA 01923-2579, United States Dundee Park, Bldg. 17 Phone: 978-777-5410 Acist Medical Systems, Inc. Andover, MA 01810, United States Fax: 800-422-8666 7905 Fuller Road Phone: 978-470-1177 Email: [email protected] Eden Prairie, MN 55344, United States Email: [email protected] Website: www.abiomed.com Phone: 952-995-9300 Website: www.abd-inc.com Year established: 1981 Fax: 888-667-6648 Year established: 1987 Source: MDRWeb.com 201 Advanced Bionics Corp. Aesthetic And Alcon Manufacturing, Ltd. 28515 Westinghouse Place Reconstructive Technologies, Inc. 6065 Kyle Lane Valencia, CA 91355, United States 3545 Airway Dr., Suite 106 Huntington, WV 25702-9795, United States Phone: 661-362-1400 Reno, NV 89511, United States Phone: 304-736-5230 Fax: 800-678-2575 Phone: 775-853-6800 Website: www.alcon.com Email: [email protected] Website: www.advancedbionics.com Af Instrumente Alcon Manufacturing, Ltd. Year established: 1993 Karlstr. 7-9 714 Columbia Ave. Tuttlingen, 78532, Germany Sinking Spring, PA 19608, United States Advanced Bio-Surfaces, Inc. Phone: 074-61-4320 Phone: 817-551-6813 5909 Baker Road, Suite 550 Minnetonka, MN 55345, United States Affinity Medical Technology, Llc. Alcon Research, Ltd. Phone: 952-912-5400 3025 Harbor Lane N., Suite 105 6201 South Fwy. Plymouth, MN 55447, United States Fort Worth, TX 76134-2001, United States Advanced Endoscopy Devices, Inc. Phone: 763-744-0412 Phone: 817-293-0450 22134 Sherman Way Fax: 800-862-5266 Canoga Park, CA 91303, United States Afton Medical Llc Email: [email protected] Phone: 818-227-2720 3137 Swetzer Rd. Suite C Website: www.alconlabs.com Fax: 818-227-2724 Loomis, CA 95650, United States Year established: 1945 Email: [email protected] Phone: 707-577-0685 Website: www.aed.md Alexandria Research Technologies, Llc Year established: 1985 Aircast Llc 13755 First Avenue North, Suite 100 1430 Decision St. Plymouth, MN 55441, United States Advanced Infusion, Inc. Vista, CA 92081, United States Phone: 952-949-2235 466 West Arrow Hwy., Unit H Phone: 760-727-1280 San Dimas, CA 91773, United States Fax: 760-734-3595 Alfred Ueda Phone: 909-305-9857 Email: [email protected] 145 Uplands Cir. Website: www.aircast.com Corte Madera, CA 94925, United States Advanced Materials, Inc. Year established: 2001 Phone: 307-789-2088 20211 South Susana Rd. Rancho Dominguez, CA 90221, United States Airgas-Southwest, Inc. Alimed, Inc. Phone: 310-537-5444 9950 Chemical Rd. 297 High St. Pasadena, TX 77507, United States Dedham, MA 02026-2844, United States Advanced Motion Measurement, Llc Phone: 361-288-0587 Phone: 781-329-2900 1202 East Maryland Ave., Suite 1j Website: www.airgas.com Fax: 781-329-8392 Phoenix, AZ 85014, United States Year established: 1982 Email: [email protected] Phone: 602-263-8657 Website: www.alimed.com Airway Division Of Surgical Appliance Year established: 1970 Advanced Ocular Prosthetics Inc. Industries, Inc. 1111 Oakdale Rd., Suite 5 3960 Rosslyn Dr. All Star Orthodontics, Llc Oakdale, PA 15071, United States Cincinnati, OH 45209-1110, United States 4570 Progress Dr. Phone: 412-787-7277 Phone: 513-271-4594 Columbus, IN 47201, United States Fax: 800-888-0458 Phone: 812-314-0804 Advanced Orthogonal Equipment, Incorporated Email: [email protected] 2201 62nd Avenue North Website: www.airwaymast.com Allegiance Healthcare Corp. Saint Petersburg, FL 33702, United States Zona Franca Las Americas, Autlas Americas Km Phone: 757-224-0177 Aisling Industries 22 1-2 Sur 621 East Heil Ave. Santo Domingo, Dominican Republic Advanced Orthopaedic Solutions, Inc. El Centro, CA 92243, United States Phone: 847-473-1500 386 Beech Ave., Unit B6 Phone: 760-353-4000 Torrance, CA 90501, United States Email: [email protected] Allen Medical Systems, Inc. Phone: 310-533-9966 Website: www.aislinginc.com 1 Post Office Square Acton, MA 01720, United States Advanced Spine Technology, Inc. Aiv, Inc. (Formerly American Iv) Phone: 978-263-5401 457 Mariposa St. 7485 Shipley Avenue Fax: 800-433-5774 San Francisco, CA 94107, United States Harmans, MD 21077, United States Email: [email protected] Phone: 415-241-2400 Phone: 410-787-1300 Website: www.allenmedical.com Fax: 800-990-2911 Advanced Stent Technologies Email: [email protected] Allergan 6900 Koll Center Pkwy., #415 Website: www.aiv-inc.com 2525 Dupont Dr. Pleasanton, CA 94566, United States Irvine, CA 92623, United States Phone: 508-650-8798 Al.Noor Corp. Phone: 949-752-4500 Website: www.bostonscientific.com P.o. Box 2154, Kotli Behram Fax: 800-366-6554 Sialkot, Punjab, Pakistan Website: www.Allergan.com Aerodyne Controls, Inc., A Circor International Phone: 043-2-264821 Company Allergan 30 Haynes Ct. Alabama Tissue Center, Inc. 71 S. Los Carneros Rd. Ronkonkoma, NY 11779-7220, United States 1900 University Blvd., 855 Tinsley Harrison Tower Goleta, CA 93117, United States Phone: 631-737-1900 Birmingham, AL 35294, United States Phone: 805-683-6761 Email: [email protected] Phone: 205-934-4314 Fax: 800-624-4261 Website: www.aerodyne-contols.com Website: www.inamedcorp.com Albuquerque Eye Prosthetics, Inc. Aesculap Implant Systems Inc. 4117 Montgomery N.e. Allesee Orthodontic Appliances 3773 Corporate Pky. Albuquerque, NM 87109, United States 13931 Spring St. Center Valley, PA 18034, United States Phone: 505-884-2927 Sturtevant, WI 53177, United States Phone: 610-984-9081 Phone: 714-516-7484 Fax: 1-800-234-9179 Alceram Tech Inc Email: [email protected] 57 2ND ST Allez Medical Applications, Inc. Website: www.aesculapusa.com Ronkonkoma, NY 11779-5352, United States 2141 S. Standard Avenue Year established: 1977 Phone: 516-849-3666 Santa Ana, CA 92707, United States Email: [email protected] Phone: 714-641-2098 Aesculap Implant Systems, Inc. Website: www.alceram.com 9999 Hamilton Blvd., Bldg 8 Allez Spine, Llc Breiningsville, PA 18031, United States 2301 Dupont Drive, Suite 510 Phone: 610-984-9074 Irvine, CA 92612, United States Phone: 949-752-7885 Source: MDRWeb.com 202 Allgaier Instrumente Gmbh Amann Medizintechnik American Medical Systems, Inc. Teuchelgrube 6-10, Frittlingen, 78665, Germany Neuhauser Str. 43 10700 Bren Road W. Phone: 7426/9615-0 Emmingen-Liptingen, 78576, Germany Minnetonka, MN 55343, United States Fax: 7426/9615-30 Phone: 49-746-59267 Phone: 952-930-6000 Email: [email protected] Fax: 800-328-3881 Website: www.allgaier-instrumente.de Ambu A/S Website: www.visitams.com 6740 Baymeadow Dr. Year established: 1972 Alliant Healthcare Products Glen Burnie, MD 21060, United States 8850 M89 Phone: 457-225-2210 American Orthopedic Supply Co., Inc. Richland, MI 49083, United States 37017 State Hwy. 79 Phone: 269-629-0300 Ambu Intl. A/S Cleveland, AL 35049, United States Sondre Ringvej 49 Phone: 205-274-7137 Allied Biomedical Brondby, Denmark PO Box 392 Phone: 45-432-40101 American Red Cross National Tissue Services Ventura, CA 93003, United States 3535 Hyland Ave. Phone: 805-289-1665 Ambu, Inc. Costa Mesa, CA 92626, United States Fax: 800-276-1322 6740 Baymeadow Drive Phone: 202-303-4280 Email: [email protected] Glen Burnie, MD 21060, United States Website: www.alliedbiomedical.com Phone: 410-768-6464 American Surgical Instrument Corp. Fax: 800-262-8462 26 Plaza Drive Allied Healthcare Products, Inc. Email: [email protected] Westmont, IL 60559-1124, United States 1720 Sublette Ave. Website: www.ambu.com Phone: 630-986-8032 St. Louis, MO 63110-1927, United States Fax: 630-986-0065 Phone: 314-771-2400 Amedica Corporation Email: [email protected] Fax: 800-444-3954 1885 West 2100 South Website: www.asico.com Salt Lake City, UT 84119, United States Year established: 1983 Alpha Medical Instruments Llc Phone: 801-839-3500 23455 Madero, Suite B Fax: 801-839-3605 American Tooth Industries Mission Viejo, CA 92691, United States Email: [email protected] 1200 Stellar Dr. Phone: 949-460-0944 Website: www.amedicacorp.com Oxnard, CA 93033-2404, United States Email: [email protected] Phone: 805-487-9868 Website: www.alphamedicalinstruments.com America Hears, Inc. Fax: 800-235-4639 806 Beaver St. Email: [email protected] Alphatec Spine, Inc. Bristol, PA 19007, United States Website: www.americantooth.com 5818 El Camino Real Phone: 215-788-0330 Carlsbad, CA 92008, United States Amerivac Usa Inc. Phone: 760-494-6769 American Catheter Corp. 1207 Pennsylvania Ave. 13047 S. Hwy 475 Linden, NJ 07036, United States Alpine Dental Laboratory, Inc. Ocala, FL 34480, United States Phone: 908-486-5200 1220 North 500 West Phone: 352-245-4816 Lehi, UT 84043-1117, United States Fax: 800-345-6714 Ametek Phone: 801-766-2200 Email: [email protected] 8600 Somerset Dr. Fax: 800-884-5047 Website: www.internationalmedical.com Largo, FL 33773, United States Email: [email protected] Year established: 1986 Phone: 727-536-7831 Website: www.alpinedental.com American Dental Center Of Provo Amoena Alsius Corp. 777 North 500 West, Ste. 201b 1701 Barret Lakes Blvd., Suite 410 15770 Laguna Canyon, Suite 150 Provo, UT 84601, United States Kennesaw, GA 30144, United States Irvine, CA 92618, United States Phone: 801-375-8200 Phone: 770-281-8300 Phone: 949-453-0150 Fax: 800-726-6362 Email: [email protected] American Dental Designs Inc. Email: [email protected] Website: www.alsius.com 1116 Horsham Rd. Website: www.us.amoena.com North Wales, PA 19454, United States Year established: 1977 Altiva Corp. Phone: 215-643-3232 9800-i Southern Pine Blvd. Amplicord Di G. Salvatore Charlotte, NC 28273, United States American Hand Prosthetics, Inc. Via Sicilia 137 Phone: 704-409-1750 73 Skillman Ave. Roma, 187, Italy Fax: 866-425-8482 Brooklyn, NY 11211, United States Phone: 06-487-2134 Email: [email protected] Phone: 212-213-3700 Website: www.altivacorp.com Amsino International, Inc. Year established: 1996 American Hearing Systems Inc. 855 Towne Center Drive 8001 East Bloomington Freeway Pomona, CA 91767, United States Alto Development Corp. Bloomington, MN 55420, United States Phone: 909-626-5888 5206 Asbury Road Phone: 763-404-1122 Fax: 800-MD-AMSINO Farmingdale, NJ 07727-3516, United States Email: [email protected] Phone: 732-938-2266 American Medical Products, Inc. Website: www.amsino.com Email: [email protected] 713 South Darrow Drive Year established: 1993 Website: www.aemedical.com Tempe, AZ 85281-3313, United States Year established: 1968 Phone: 480-967-0384 Amsino Medical Usa Fax: 800-279-1999 5209 Linbar Dr., Suite 640 Altron, Inc. Email: [email protected] Nashville, TN 37211, United States 6700 Bunker Lake Blvd. N.W. Website: www.oxyears.com Phone: 615-332-9959 Minneapolis, MN 55303-5852, United States Year established: 1985 Phone: 763-427-7735 Andersen Products, Inc., Email: [email protected] American Medical Specialties, Inc. Health Science Park, 3202 Caroline Drive Website: www.altronmfg.com 10650 77th St., Suite 405 Haw River, NC 27258-9564, United States Year established: 1974 Largo, FL 33777, United States Phone: 336-376-3000 Phone: 727-561-9400 Fax: 800-523-1276 A-M Systems, Inc. Fax: 800-808-2877 Email: [email protected] 131 Business Park Loop Email: [email protected] Website: www.anpro.com Sequim, WA 98382, United States Website: www.ammeds.com Year established: 1958 Phone: 360-683-8300 Year established: 1992 Fax: 800-426-1306 Anderson Eye Prosthetics Email: [email protected] 164 East 5900 South, #101-b Website: www.a-msystems.com Murray, UT 84107, United States Year established: 1976 Phone: 801-262-6711 Source: MDRWeb.com 203 Andronic Devices Anspach Effort, Inc. Applied Medical Technology, Inc. 2335 Bayswater St. 4500 Riverside Dr. 8000 Katherine Boulevard Vancouver, BC V6K-4B2, Canada Palm Beach Gardens, FL 33410, United States Brecksville, OH 44141, United States Phone: 604-732-9181 Phone: 561-627-1080 Phone: 440-717-4000 Fax: 604-732-9182 Fax: 561-625-9110 Fax: 800-869-7382 Year established: 1984 Email: [email protected] Email: [email protected] Website: www.anspach.com Website: www.appliedmedical.net Anesthesia Associates, Inc. 460 Enterprise St. Antonio Ribeiro-Belodente Applied Spine Technologies, Inc. San Marcos, CA 92078-4363, United States Produtos Dentarios, Ltda 300 George Street, Suite 511 Phone: 760-744-6561 2 Dto, Rua Antero De Quental, 14 New Haven, CT 06511, United States Email: [email protected] Lisboa, 1100, Portugal Phone: 203-503-0280 Website: www.AincA.com Phone: 1/885-2389 Fax: 203-503-0282 Year established: 1958 Email: [email protected] Email: [email protected] Website: www.appliedspine.com Angiodynamics, Inc. Anulex Technologies, Inc 14 Plaza Drive 5600 Rowland Road, Suite 280 Aptis Medical, Llc. Latham, NY 12110, United States Minnetonka, MN 55343, United States 3602 Glenview Ave Phone: 518-795-1400 Phone: 952-224-4000 Glenview, KY 40025, United States Email: [email protected] Fax: 877-326-8539 Phone: 502-899-9700 Website: www.angiodynamics.com Email: [email protected] Year established: 1988 Website: www.anulex.com Arc Surgical Llc. 21300 Nw Jacobson Rd. Angiodynamics, Inc. Apc Medical Ltd. Hillsboro, OR 97124, United States One Horizon Way 68 Tewin Road Phone: 503-627-9957 Manchester, GA 31816, United States Welwyn Garden City, AL7 1BD, United Kingdom Phone: 706-846-3126 Phone: 1707/327-641 Ardus Medical, Inc. Fax: 800-472-5221 Email: [email protected] 11297 Grooms Rd. Email: [email protected] Website: www.apcmedical.com Cincinnati, OH 45242, United States Website: www.angiodynamics.com Phone: 513-469-7867 Year established: 1990 Apex Medical Technologies, Inc. Fax: 800-878-1388 10064 Mesa Ridge Ct., Suite 202 Email: [email protected] Angiodynamics, Inc. San Diego, CA 92121-2948, United States Website: www.ardusmedical.com 46421 Landing Parkway Phone: 858-535-0012 Year established: 1994 Fremont, CA 94538, United States Fax: 800-345-3208 Phone: 510-771-0400 Email: [email protected] Argon Medical Devices Inc. Website: www.angiodynamics.com Website: www.apexmedtech.com 1445 Flat Creek Rd. Year established: 1994 Year established: 1985 Athens, TX 75751, United States Phone: 903-675-9321 Angiomed Gmbh & Co. Medizintechnik Kg Apheresis Technologies, Inc. Website: www.argonmedical.com Wachhausstr. 6 PO Box 2081 Karlsruhe, 76227, Germany Palm Harbor, FL 34682-2081, United States Arise Diffusion Sa Phone: 908-277-8000 Phone: 727-787-5616 Postfach 658 Fax: 800-749-9284 Moutier, 2740, Switzerland Angioscore, Inc. 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BridgePoint Medical 117 Flanders Road 1285 Corporate Center Dr., Suite 150 2800 Campus Drive, #50 Westborough, MA 01581-1042, United States Eagan, MN 55121, United States Plymouth, MN 55441, United States Phone: 508-898-9300 Phone: 651-286-8620 Phone: 763-225-8500 Fax: 800-433-2674 Fax: 800-328-2719 Website: www.bridgepointmedical.com Email: [email protected] Email: [email protected] Year established: 2006 Website: www.bosmed.com Website: www.braemarinc.com Year established: 1980 Year established: 1998 Bridger Biomed, Inc. 2430 North 7th Ave. Boston Scientific - Maple Grove Brailsford & Co., Inc. Bozeman, MT 59715, United States One Scimed Place 15 Elm Avenue Phone: 908-277-8000 Maple Grove, MN 55311-1566, United States Antrim, NH 03440, United States Phone: 763-494-1700 Phone: 603-588-2880 Bruce Cook, Prosthetics Fax: 800-553-5878 Email: [email protected] 2821 North Ballas, #215 Website: www.bostonscientific.com Website: www.brailsfordco.com Crystal Lake Park, MO 63131, United States Year established: 1944 Phone: 314-567-7585 Boston Scientific - Marina Bay Customer Fulfillment Center Brandel Bruno & Andreas Kohler Medizintechnik Gbr. 500 Commander Shea Blvd 8561 Atlas Dr. Hauptstrasse 5-A Quincy, MA 02171, United States Gaithersburg, MD 20877-4135, United States Neuhausen Ob Eck-Schwandorf, Germany Phone: 617-689-6000 Phone: 301-948-6506 Phone: 49-77-77-931 Website: www.bostonscientific.com Fax: 800-948-6506 Email: [email protected] Bryton Corp. Boston Scientific Cork Ltd. Website: www.brandel.com 4310 Guion Rd. Model Farm Rd. Indianapolis, IN 46254-3111, United States Cork, N/A, Ireland Brasseler Usa - Komet Medical Phone: 317-334-8700 Phone: 508-650-8000 One Brassler Blvd. Fax: 317-334-8787 Website: www.bostonscientific.com Savannah, GA 31419-9565, United States Email: [email protected] Phone: 912-925-8525 Website: www.brytoncorp.com Boston Scientific Corp. Fax: 800-535-6638 Year established: 1981 6645 185th Ave. N.E. Email: [email protected] Redmond, WA 98052, United States Website: www.kometmedical.com Bsn Medical, Inc. Phone: 612-582-7448 100 Beiersdorf Drive Website: www.bostonscientific.com Brasseler Usa - Medical Rutherford College, NC 28671, United States 4837 McGrath Street, Suite J Phone: 800-552-1157 Boston Scientific Corp. Ventura, CA 93003, United States 5905 Nathan Lane Phone: 805-650-5209 Busse Hospital Disposables, Inc. 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Boston Scientific Corp. Brava, Llc Byron Medical 150 Baytech Dr. 2601 South Bayshore Dr., Suite 725 602 W. Rillito San Jose, CA 95134, United States Coconut Grove, FL 33133, United States Tucson, AZ 85705, United States Phone: 408-935-3400 Phone: 305-856-4242 Phone: 520-573-0857 Fax: 800-777-3434 Boston Scientific Corporation Bray Corporation Email: [email protected] One Boston Scientific Place 14149 Calle Contesa Website: www.byronmedical.com Natick, MA 01760-1537, United States Victorville, CA 92392, United States Year established: 2002 Phone: 508-650-8000 Phone: 760-345-6689 Fax: 800-225-2732 C. R. Bard, Inc., Bard Medical Div. Website: www.bostonscientific.com Breg, Inc., An OrthofixC ompany 8195 Industrial Blvd. Year established: 1979 2611 Commerce Way Covington, GA 30209, United States Vista, CA 92081, United States Phone: 770-784-6100 Boston Scientific Corporation Phone: 760-599-3000 Fax: 800-526-4455 8600 N.w. 41st Street Fax: 800-897-BREG Email: [email protected] Miami, FL 33166, United States Email: [email protected] Website: www.bardmedical.com Phone: 508-652-5578 Website: www.breg.com Year established: 1989 C. R. Bard, Inc., Bard Urological Div. Boston Scientific Corporation 13183 Harland Dr. 780 Brookside Drive Brennen Medical, Llc Covington, GA 30014, United States Spencer, IN 47460, United States 1290 Hammond Rd. Phone: 678-342-4800 Phone: 508-652-5578 St. Paul, MN 55110, United States Fax: 888-367-2273 Phone: 651-429-7413 Email: [email protected] Boston Scientific Ireland, Ltd. Website: www.bardurological.com Ballybrit Business Park, Ballybrit Brenner Metal Products Year established: 1904 Galway, Ireland 16 Main Ave. Phone: 508-650-8000 Wallington, NJ 07057, United States C.O.R.E. Tech, Inc. Website: www.bostonscientific.com Phone: 973-778-2466 542 E. 200 N. Warsaw, IN 46582, United States Boston Scientific Neuromodulation Corporation Brentwood Industries, Inc. Phone: 574-267-5744 25155 Rye Canyon Loop 610 Morgantown Rd. Email: [email protected] Valencia, CA 91355, United States Reading, PA 19611, United States Website: www.coretech-inc.com Phone: 508-652-5578 Phone: 610-374-5109 Year established: 1985 Website: www.bostonscientific.com Website: www.brentwoodindustries.com Year established: 1965 C.P. Bourg Sa Boston Scientific-Neurovascular Rue Des Technologies 22 47900 Bayside Pkwy. Brevet, Inc. Ottignies, 1340, Belgium Fremont, CA 94538-6515, United States 16661 Jamboree Blvd. Phone: 10/613-838 Phone: 510-440-7700 Irvine, CA 92606, United States Fax: 10/613-638 Website: www.bostonscientific.com Phone: 949-474-7000 Email: [email protected] Website: www.brevet.com Year established: 1978

Source: MDRWeb.com 209 Cadence Science Inc. Cardeon Corp. Cardiovascular Systems, Inc. 1979 Marcus Ave, Suite 215 10600 North Tantau Ave. 651 Campus Drive Lake Success, NY 11042, United States Cupertino, CA 95014, United States St. Paul, MN 55112, United States Phone: 516-248-0300 Phone: 408-253-3319 Phone: 651-259-1600 Fax: 888-717-7677 Fax: 877-CSI-0360 Email: [email protected] Cardiac Assist, Inc. Email: [email protected] Website: www.cadencescience.com 240 Alpha Dr. Website: www.csi360.com Year established: 1922 Pittsburgh, PA 15238, United States Phone: 412-963-7770 Cardiovention, Inc. Caguas Orthopedic Center, Inc. Website: www.cardiacassist.com 19200 Stevens Creek Blvd., #200 Ff4, Calle 11, 4th Secc., Villa Del Rey Year established: 1996 Cupertino, CA 95014, United States Caguas, PR 00625, United States Phone: 408-873-3400 Phone: 787-744-2325 Cardiac Impulse S.R.L. Via del Cornocchio, 1 Care Rehab And Orthopaedic Products, Inc. Caldera Medical Inc. Barberino Di Mugello, FI 50031, Italy 3930 Horseshoe Bend Road 5171 Clareton Drive Phone: +39 0558420130 Keysville, VA 23947, United States Agoura Hills, CA 91301, United States Email: [email protected] Phone: 703-448-9644 Phone: 818-879-6555 Website: www.cardiacimpulse.com Fax: 866-422-5337 Year established: 1970 Caremed Medical Products Ag Website: www.calderamedical.com Grenzstr. 28 Year established: 2002 Cardial, S.A. Dresden, 1109, Germany 28 Rue De La Telematique Phone: 357/88491-10 Calibra Medical Inc. St Etienne, 42000, France Email: [email protected] 220 saginaw drive Phone: 908-277-8000 Redwood City, CA 94063, United States Caridianbct Inc. Phone: 650-298-4710 Cardica, Inc. 10810 W. Collins Ave. Email: [email protected] 900 Saginaw Dr. Lakewood, CO 80215, United States Website: www.myfinesse.com Redwood City, CA 94063, United States Phone: 303-232-6800 Phone: 650-364-9975 Fax: 800-525-2623 California Medical Innovations Fax: 888-544-7194 Email: [email protected] 873 E. Arrow Highway Website: www.cardica.com Website: www.caridianbct.com Pomona, CA 91767, United States Year established: 1997 Year established: 1964 Phone: 909-621-5871 Fax: 800-229-5871 Cardima, Inc. Carl Heyer, Inc. Email: [email protected] 47266 Benicia St. 1872 Bellmore Avenue Website: www.cal-med-innovations.com Fremont, CA 94538-1372, United States North Bellmore, NY 11710, United States Year established: 1986 Phone: 510-354-0166 Phone: 516-783-7800 Fax: 888-354-0300 Email: [email protected] California Medical Laboratories, Inc. Website: www.cardima.com Website: www.dexiter.com 1570 Sunland Lane Year established: 1976 Costa Mesa, CA 92646, United States Cardinal Health 303,Inc. Phone: 714-556-7365 1515 Ivac Way Carole Lewis Stolpe’ B.C.O. Email: [email protected] Creedmoor, NC 27522, United States 435 N. Bedford Drive, Suite 411 Website: www.calmedlab.com Phone: 858-458-7830 Beverly Hills, CA 90210, United States Year established: 1993 Website: www.cardinal.com Phone: 310-271-8801

Candela Corp. Cardinal Health, Snowden Pencer Products Carolina Eye Prosthetics, Inc. 530 Boston Post Rd. 5175 South Royal Atlanta Dr. 420 Maple Ave. Wayland, MA 01778-1833, United States Tucker, GA 30084-3053, United States Burlington, NC 27215, United States Phone: 508-358-7637 Phone: 847-689-8410 Phone: 336-228-7877 Fax: 800-733-8550 Website: www.cardinal.com Website: www.candelalaser.com Carpal Doctors Llc Year established: 1970 Cardio Command, Inc. 701 Brickell Avenue, Suite 1550 4920 W. Cypress St., Suite 110 Miami, FL 33131, United States Candulor Dental Gmbh Tampa, FL 33607, United States Phone: 866-401-1213 Am Riederngraben 6 Phone: 813-289-5555 Email: [email protected] Rielasingen-Worblingen, 78239, Germany Fax: 800-231-6370 Website: www.carpaldoctors.com Phone: 7731/52075 Email: [email protected] Website: www.cardiocommand.com Carr Corporation Caplugs West Year established: 1988 1547 11th St. 18704 S. Ferris Place Santa Monica, CA 90401, United States Rancho Dominguez, CA 90220, United States Cardiomed Supplies Inc. Phone: 310-587-1113 Phone: 310-537-2300 5 Gormley Industrial Ave., P.O. Box 575 Fax: 310-395-9751 Gormley, ON L0H 1G0, Canada Email: [email protected] Capro Solutions, Llc Phone: 905-888-1965 Website: www.carrcorporation.com 8 Corporate Cir., Karner Park Fax: 800-387-9757 Year established: 1946 Albany, NY 12203, United States Email: [email protected] Phone: 518-456-1145 Website: www.cardiomed.com Cascade Life Solutions, Llc Year established: 1979 3710 Sysco Court Se Capstone Therapeutics Grand Rapids, MI 49512, United States 1275 W. Washington St. Cardiomedics, Inc. Phone: 616-977-2505 Tempe, AZ 85281, United States 18872 Bardeen Ave. Phone: 602-286-5520 Irvine, CA 92612, United States Case Medical, Inc. 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Medical Instrument Co., Ltd. 72 Pennsylvania Avenue Roseville, CA 95678, United States 12 Pu Dong Rd. Malvern, PA 19355, United States Phone: 916-677-1790 Changchun, China Phone: 610-240-9980 Phone: 431-463-3327 Fax: 610-240-9982 Catheter Connections Inc. Email: [email protected] 615 Arapeen Dr, Suite 302a Changchun Kangda Medical Supply Co., Ltd. Website: www.circulatorboot.com Salt Lake City, UT 84108, United States 4 Huo Ju Rd. Phone: 1-888-706-8883 Changchun, China Circulatory Technology, Inc. Email: [email protected] Phone: 86-431-51797 21 Singworth St. Website: www.catheterconnections.com Oyster Bay, NY 11771, United States Changshu Taining High Polymer Medical Phone: 516-624-2424 Catheter Innovations, Inc. Products Co. 3598 West 1820 South Yangyuan Cirugia Peruana S.A. Salt Lake City, UT 84104-4859, United States Changshu, 215500, China Avenida Colonial 1255 Phone: 801-954-8444 Phone: 86-520-24712 Lima 1, Peru Fax: 800-418-2828 Phone: 511-431-8589 Website: www.bostonscientific.com Chase Medical, Lp 1876 Firman Dr. Citow Cervical Visualizer Company Catheter Research, Inc. (Cri) Richardson, TX 75081, United States 712 South Milwaukee Avenue 5610 W. 82nd St.,Indianapolis, IN 46278, United States Phone: 972-783-0644 Green Oaks, IL 60048, United States Phone: 317-872-0074 Phone: 646-460-2984 Email: [email protected] Chattanooga Group Website: www.catheterresearch.com 1430 Decision Street Civco Medical Instruments Co., Inc. Year established: 1987 Vista, CA 37343-0489, United States 102 First St. South Phone: 760-727-1280 Kalona, IA 52247, United States C-Axis P.R., Inc. Fax: 800-242-8329 Phone: 319-656-4447 Parque Industrial Valle Polima, Edif Multifabril 14- Website: www.chattgroup.com a-2 Year established: 1947 Clarus Medical, Llc. Caguas, PR 00727, United States 1000 Boone Ave. North, Suite 300 Phone: 787-286-0590 Chifa Minneapolis, MN 55427, United States Ul. Tysiaclecia Phone: 763-525-8400 Center For Ocular Prosthetics, Llc. Nowy Tomysl, Poland 2525 N.w. Lovejoy, Suite 306 Phone: 708-582-1010 Clinical Innovations, Inc. Portland, OR 97210, United States 747 West 4170 South Phone: 503-229-8490 Choices Technologies Murray, UT 84123, United States 21730-176th Ave. South East Phone: 801-268-8200 Center For Ocular Reconstruction Kent, WA 98042-7210, United States Fax: 888-268-6222 4833 Rugby Ave., 4th Flr. Phone: 425-765-9400 Email: [email protected] Bethesda, MD 20814, United States Website: www.clinicalinnovations.com Phone: 301-652-9282 Christian Diener Gmbh. & Co. K.G. Year established: 1993 Rudolf-Diesel-Str. 18 Centerpulse Orthopedics Inc. Tuttlingen, 78532, Germany Clinical Instruments Intl., Inc. 9900 Spectrum Drive Phone: 746-1 7-1067 278 Worcester St. Austin, TX 78717, United States Southbridge, MA 01550, United States Phone: 512-432-9900 Christy Manufacturing Corp. Phone: 508-764-2200 Fax: 877-768-7349 1228-f Quarry Ln. Email: [email protected] Pleasanton, CA 94566, United States Cloward Instrument Corporation Website: www.sulzerorthopedics.com Phone: 925-462-7982 3787 Diamond Head Road Honolulu, HI 96816, United States Centinel Spine Inc. Churchill Medical Systems, Inc. Phone: 808-734-3511 505 Park Ave., 14th Floor 103a Park Drive Fax: 808-734-3511 New York, NY 10022, United States Montgomeryville, PA 19044, United States Email: [email protected] Phone: 952-885-0500 Phone: 215-956-0585 Website: www.cloward.com Email: [email protected] Fax: 800-468-0585 Year established: 1991 Website: www.centinelspine.com Email: [email protected] Website: www.ChurchillMedicalSystems.com Cm-Instrumente Vertriebsgesellschaftmbh Central New York Medical Products Year established: 1987 Gänsäcker 58 749 W. Genesee St,Syracuse, NY 13204, United States Tuttlingen, 78532, Germany Phone: 315-428-9945 Cianna Medical, Inc. Phone: 074-629-2438 Email: [email protected] 6 Journey, Suite 125 Website: www.cnymedpro.com Aliso Viejo, CA 92656, United States Cml Consortium De Materiel Pour Lab. Year established: 1981 Phone: 949-360-0059 7 Rve Des Palis Fax: 866-920-9444 Nemours Cedex, 77792, France Centurion Medical Products Corp. Email: [email protected] Phone: 1/64-45-42-42 3310 South Main St. Website: www.ciannamedical.com Fax: 1/64-78-14-69 Salisbury, NC 28147, United States Phone: 517-545-1135 Ciba Vision Puerto Rico, Inc. Cmt, Inc. Website: www.tristate.com El Jibaro Industrial Park Post Office Box 297 Cidra, PR 00739, United States Hamilton, MA 01936-0297, United States Cft, Inc./Life Mask Phone: 678-415-3638 Phone: 978-768-2555 14602 N. Cave Creek Road, Suite B Fax: 800-659-9140 Phoenix, AZ 85022, United States Cima Technology, Inc. Email: [email protected] Phone: 602-992-1220 3253-c Old Frankstown Road Website: www.habitatmonitor.com Fax: 800-331-8844 Pittsburgh, PA 15239, United States Year established: 1984 Email: [email protected] Phone: 724-733-2627 Website: www.cprlifemask.com Coapt Systems, Inc. Year established: 1989 Cimex Medical Innovations, Llc 1820 Embarcadero Rd. 72385 Industry Park Palo Alto, CA 94303, United States Chandjee Manufacturing Co. Covington, LA 70435, United States Phone: 650-461-7600 P.o. Box 1255, Jinnah Islamia College Rd. Phone: 985-871-0802 Sialkot, Pakistan Coastal Biocare Phone: 432/580-589 2737 South Croddy Way, Unit D Fax: 432/269-044 Santa Ana, CA 92704, United States Email: [email protected] Phone: 714-751-0121 Website: www.chandjee.com.pk Source: MDRWeb.com 211 Coastal Life Systems, Inc. Composiflex, Inc. Cook Endoscopy 1803 Grandstand Drive 8100 Hawthorne Circle, Erie, PA 16509, United States 4900 Bethania Station Rd. &, 5951 Grassy Creek San Antonio, TX 78238, United States Phone: 814-866-8616 Blvd., North, NC 27105, United States Phone: 210-684-7553 Fax: 814-866-0563 Phone: 336-744-0157 Fax: 800-727-6814 Email: [email protected] Email: [email protected] Website: www.composiflex.com Cook Inc. Website: www.coastallifesystems.com Year established: 1985 PO Box 489 Year established: 1989 Bloomington, IN 47402-0489, United States Concentric Medical, Inc. 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Cochlear Americas Conceptus, Inc. Cook Ob/Gyn 400 Inverness Parkway, Suite 400 331 East Evelyn Ave. 1100 W. Morgan St. Englewood, CO 80112-5128, United States Mountain View, CA 94041, United States Spencer, IN 47460, United States Phone: 303-790-9010 Phone: 650-962-4000 Phone: 812-829-6500 Email: [email protected] Email: [email protected] Fax: 800-541-5591 Website: www.cochlearamericas.com Website: www.conceptus.com Email: [email protected] Year established: 1985 Year established: 1992 Website: www.cookgroup.com

Codan Medical Aps Conformis, Inc. Cook Urological, Inc. Faergevej 4 11 North Ave., Burlington, MA 01803, United States 1100 West Morgan St., P.O. Box 227 Rødby, 4970, Denmark Phone: 781-345-9001 Spencer, IN 47460, United States Phone: 45-48-167000 Website: www.conformis.com Phone: 812-829-4891 Year established: 2004 Fax: 800-457-4500 Codan Portugal - Instrumentos Medicos, Ltda. Email: [email protected] Rua Monte Lavouro ConMed Corporation Website: www.cookmedical.com Odivelas, 2675, Portugal 310 Broad Street Year established: 1977 Phone: 21/933-7237 Utica, NY 13501, United States Phone: 800-448-6506 Cook Vascular, Incorporated Codman & Shurtleff, Inc Email: [email protected] 1186 Montgomery Lane 325 Paramount Dr. Website: www.conmed.com Vandergrift, PA 15690, United States Raynham, MA 02767, United States Year established: 1970 Phone: 724-845-8621 Phone: 508-880-8100 Fax: 800-457-4500 Fax: 800-225-0460 ConMed Endoscopic Technologies Email: [email protected] Email: [email protected] One Executive Drive, Suite 101 Website: www.cookmedical.com Website: www.codmanjnj.comwww.depuy.com/ Chelmsford, MA 01824, United States Year established: 1981 corporate-information Phone: 800-448-6506 Year established: 1857 Email: [email protected] Cordis Corporation Website: www.conmed.com 430 Route 22 East Col-Bar Ltd. Bridgewater, NJ 08807, United States 10 Hashomron St. ConMed Linvatec Phone: 908-541-4100 Ramat-Hasharon, Israel 11311 Concept Blvd. Fax: 800-447-7585 Phone: 972-354-7080 Largo, FL 33773-4908, United States Website: www.cordis.com Phone: 800-448-6506 Year established: 1959 Co-Ligne Ag Email: [email protected] Utoquai 43 Website: www.conmed.com Cordis Llc Zurich, Switzerland Year established: 1963 Road 362 Km 0.5 Phone: 41-1-2614888 San German, PR 00683, United States ConMed Linvatec Endoscopy Phone: 786-313-2000 Collagen Matrix, Inc. 7416 Hollister Avenue Fax: 877-338-4235 509 Commerce St. Goleta, CA 93117, United States Website: www.cordis.com Franklin Lakes, NJ 07417, United States Phone: 800-448-6506 Year established: 1959 Phone: 201-405-1477 Fax: 800-438-3051 Email: [email protected] Cordis Neurovascular, Inc. Coloplast Manufacturing Us, Llc Website: www.conmed.com 14201 NW 60 Avenue 1840 West Oak Parkway Miami Lakes, FL 33014, United States Marietta, GA 30062, United States Conquerer Surgical Phone: 786-313-6550 Phone: 507-345-6200 C-46 Nishter Rd. , S. I. E., Sialkot, 22161, Pakistan Fax: 800-327-7714 Fax: 800-533-0464 Phone: 92-432-55467 Website: www.cordis.com Email: [email protected] Year established: 1959 Website: www.us.coloplast.com Consumaquip Corporation Year established: 1957 7240 NW 12th Street Core Essence Orthopaedics Inc. Miami, FL 33126-1909, United States 575A Virginia Drive Combined Instruments (Pvt.), Ltd. Phone: 305-592-4510 Fort Washington, PA 19034, United States 13-A Model Town, Ugoki Email: [email protected] Phone: 215-310-9534 Sailkot, Pakistan Email: [email protected] Phone: 04-32-510243 Contemporary Products, Inc. Website: www.ceortho.com 2055 South Main St. Comco, Inc. Middletown, CT 04103-1446, United States Core Products International, Inc. 2151 N. 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Covidien Lp, Formerly Registered As Kendall Crystal Tone Hearing Instruments 235 Constitution Drive 444 Mcdonnell Blvd. 4217 University Ave. Menlo Park, CA 94025, United States Hazelwood, MO 63042, United States Des Moines, IA 50311, United States Phone: 616-656-4563 Phone: 800-962-9888 Phone: 515-255-4144 Email: [email protected] CorMatrix Cardiovascular Inc. Website: www.covidien.com Csi Holdings 155-a moffett park drive, Suite 240 170 Commerce Way Sunnyvale, CA 94089, United States Covidien Lp, Formerly Registered As Tyco Gallatin, TN 37066, United States Phone: 408-734-2628 Healthcare Phone: 615-452-9633 Fax: 877-651-2628 15 Hampshire Street Fax: 615-452-9451 Email: [email protected] Mansfield, MA 02048, United States Email: [email protected] Website: www.cormatrix.com Phone: 508-261-8000 Website: www.csimed.com Year established: 2001 Fax: 800-962-9888 Email: [email protected] Cw Medical, Inc. Corpak Medsystems, Inc. Website: www.covidien.com 5595 Daniels St, Suite E 100 Chaddick Dr. Chino, CA 91710, United States Wheeling, IL 60090, United States Covidien Lp, Formerly Registered As United Phone: 909-591-5220 Phone: 847-403-3400 States Surgical Email: [email protected] Fax: 800-323-6305 195 Mcdermott Road Website: www.cwmedical.us Email: [email protected] North Haven, CT 06473, United States Year established: 1994 Website: www.corpakmedsystems.com Phone: 203-492-5000 Year established: 1979 Fax: 800-962-9888 Cyberbiomed, Llc Website: www.covidien.com 3605 S. Ocean Blvd. #a-335 Cortek Endoscopy, Inc. Palm Beach, FL 33480, United States 260 Jamie Lane, Unit D Covidien Lp, Formerly Registered As United Phone: 561-582-1955 Wauconda, IL 60084, United States States Surgical Phone: 847-526-2266 150 Glover Ave. Cybernetic Research Laboratories, Inc. Norwalk, CT 06856-5080, United States 3562 E. 42nd Stravenue Corvita Corp. Phone: 203-845-1000 Tucson, AZ 85713, United States 8210 N.W. 27th St. Fax: 800-962-9888 Phone: 520-571-8065 Miami, FL 33122-1900, United States Email: [email protected] Phone: 305-599-3100 Website: www.ussurg.com Cyberonics, Inc. Website: www.bostonscientific.com The Cyberonics Building, 100 Cyberonics Boulevard Cp Medical Corporation Houston, TX 77058, United States Covidien 803 NE 25th Avenue Phone: 281-228-7262 5870 Stoneridge Drive, Suite 6 Portland, OR 97232, United States Fax: 800-332-1375 Pleasanton, CA 94588, United States Phone: 503-232-1555 Email: [email protected] Phone: 303-305-2382 Fax: 800-950-2763 Website: www.cyberonics.com Website: www.covidien.com Email: [email protected] Year established: 1987 Website: www.cpmedical.com Covidien (Formerly Nellcor Puritan Bennett / Year established: 1989 Cytori Therapeutics, Inc. Tyco Healthcare) 3020 Callan Road 6135 Gunbarrel Ave Create Medic Co., Ltd. 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Phone: 305-573-2920 Commerce, TX 75428, United States Pelham, AL 35124, United States Phone: 903-886-3153 Phone: 205-733-0901 Daniel T Acosta Fax: 800-962-9888 Email: [email protected] 635 C Street, Suite 502 Email: [email protected] Website: www.crystalmedicaltech.com San Diego, CA 92101, United States Website: www.covidien.com Year established: 1994 Phone: 619-235-8950 Source: MDRWeb.com 213 Danlin Products, Inc. Dean B. Scott, Ocularist Denovo Dental, Inc. 3321 Columbia, N.E. 5225 Old Orchard Rd., Suite 27-b 5130 Commerce Drive Albuquerque, NM 87107-2001, United States Skokie, IL 60077, United States Baldwin Park, CA 91706, United States Phone: 505-884-1922 Phone: 847-965-4455 Phone: 626-939-5000 Email: [email protected] Fax: 626-939-5020 Year established: 1986 Dean B. Scott, Ocularist Email: [email protected] 1319 Butterfield Rd., Suite 524 Website: www.denovodental.com Dannoritzer Medical Instruments Downers Grove, IL 60515, United States Year established: 1988 Brenntenstr. 14 Phone: 847-965-4455 Tuttlingen, 78532, Germany Dental Procedures, Inc. L.L.C. Phone: 49-746-17221 Debiotech Sa 9 Baer Court Le Portique, Avenue de Sévelin 28 Morristown, NJ 07960, United States Danz Inc. Lausanne, CH 1004, Switzerland Phone: 973-267-6195 460 Bloomfield Ave. Room 302 Phone: +41 21 623-6000 Montclair, NJ 07042, United States Email: [email protected] Dental Usa, Inc. Phone: 973-783-2955 Website: www.debiotech.com 5005 Mccullom Lake Rd. Year established: 1990 Mchenry, IL 60050, United States Dar Expo Phone: 815-363-8003 146-C Fatima Jinnah Rd. S.i.e. Debusk Orthopedic Casting (Doc) Sialkot, Punjab, Pakistan 420 Straight Creek Road, Suite 1 Dentsply Canada, Ltd. Phone: 92-432-55070 New Tazewell, TN 37825, United States 161 Vinyl Ct. Phone: 865-362-2334 Woodbridge, ON L4L 4A3, Canada Datascope Cardiac Assist Div. Phone: 905-851-6060 15 Law Drive Dedicated Distribution Fax: 800-263-1437 Fairfield, NJ 07004, United States 640 Miami Avenue Email: [email protected] Phone: 973-244-6100 Kansas City, KS 66105-2140, United States Website: www.dentsply.ca Fax: 800-777-4222 Phone: 913-371-2200 Year established: 1899 Website: www.datascope.com Fax: 800-325-8367 Email: [email protected] Dentsply Friadent Ceramed Datascope Corp., Cardiac Assist Division Website: www.dedicateddistribution.com 12860 West Cedar Dr.,suite 110 1300 Macarthur Blvd. Year established: 1989 Lakewood, CO 80228, United States Mahwah, NJ 07430, United States Phone: 717-849-4229 Phone: 201-307-5400 Defoe Intl. P.o. Box 559, Defence Rd. Dentsply International, Inc. David Scott Company Sialkot, Pakistan Susquehanna Commerce Center, 221 W. 59 Fountain St. Phone: 92-43-41 415 Philadelphia Street Framingham, MA 01702, United States York, PA 17405-0872, United States Phone: 508-875-3333 Degania Silicone, Inc. Phone: 717-845-7511 Fax: 800-804-0333 14 Thurber Boulevard, Suite A Fax: 800-877-0020 Email: [email protected] Smithfield, RI 02917, United States Email: [email protected] Website: www.davidscottco.com Phone: 401-349-5373 Website: www.dentsply.com Year established: 1972 Email: [email protected] Year established: 1899 Website: www.deganiasilicone.com Davis And Geck Caribe, Ltd. Year established: 1984 Dentsply Maillefer Zona Franca De San Isidro, Carretara San Isidro Ch Du Verger 3 Km 17 Deknatel Snowden-Pencer Ballaigues, 1338, Switzerland Santo Domingo, Dominican Republic 5175 S. 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Fax: 770-934-4922 Website: www.maillefer.ch 100 Crossings Blvd. Warwick, RI 02886, United States Dekumed Gmbh Dentsply Prosthetics Phone: 401-463-7000 Am Anger 27 Six Terri Lane Fax: 800-556-6275 Bernau, 83233, Germany Burlington, NJ 08016, United States Website: www.davol.com Phone: 011-495-5278 Phone: 609-386-8900 Year established: 1874 Fax: 800-877-0020 Delta Systems De Mexico Email: [email protected] DAW Industries Prolongacion Las Lomas No. 16 Website: www.dentsply.com 5737 Pacific Center Blvd. Tijuana, B.c., Mexico Year established: 1899 San Diego, CA 92121, United States Phone: 702-331-1890 Phone: 858-550-6848 Dentsply Prosthetics Fax: 800-252-2828 Deltai Medical & Health 570 West College Avenue Email: [email protected] Articles (Suzhou) Co., Ltd York, PA 17404, United States Website: www.daw-usa.com 60 Feihu Rd., Ludu Phone: 800-621-0381 Taicang, Suzhou, Jiangsu, China Website: austenal.dentsply.com Dcv Instrumente Gmbh Phone: 86-520-34584 Year established: 1928 Obere Hauptstr. 18 Tuttlingen, 78532, Germany Demetech Corp. Dentsply Specialty Materials Phone: 49-746-42200 3530 N.w. 115th Ave. 1311 Smile Way Miami, FL 33178, United States York, PA 17404, United States De Good Dimensional Concepts, Inc. Phone: 305-597-5277 Phone: 717-849-4229 7815 Sr 13 N Fax: 888-324-2447 Fax: 800-877-0020 North Webster, IN 46555, United States Email: [email protected] Email: [email protected] Phone: 574-834-5437 Website: www.demetech.us Website: www.dentsply.com Year established: 1899 Dean B. Scott, Ocularist Den Tag S.R.L. 4101 Evans Ave. Via Maniago, 99 Z I Denver Biomedical, Inc. Ft. Myers, FL 33901, United States Maniago, PN 33085, Italy 14998 W. 6th Ave., Bldg. E700 Phone: 847-965-4455 Phone: 0427/715-61 Golden, CO 80401, United States Fax: 0427/700-666 Phone: 303-279-7500 Dean B. Scott, Ocularist Email: [email protected] Fax: 800-653-6827 1901 S. Osprey Ave. Website: www.dentag.com Email: [email protected] Sarasota, FL 34239, United States Website: www.denverbio.com Phone: 847-965-4455

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Depuy France S.A. 100 Rose Hill Industrial Park Via Statale 12 Nord 86 Z I La Vendue Bp88 Rose Hill, VA 24281, United States Mirandola, 41037, Italy Chaumont, France Phone: 865-362-6022 Phone: 39-053-5 298 Phone: 219-267-8143 Fax: 800-251-9864 Email: [email protected] Dimeda Instrumente Gmbh Depuy Mitek, A Johnson & Johnson Company Website: www.deroyal.com Gänsäcker 58 50 Scotland Blvd. Year established: 1973 Tuttlingen, 78532, Germany Bridgewater, MA 02324, United States Phone: 49-74-62-946 Phone: 508-880-8100 Deroyal Wound Care Fax: 800-451-2006 Hwy 58, P.O. Box 309, Rose Hill, VA 24281, United States Dio Usa Email: [email protected] Phone: 865-362-6022 3435 Wilshire Blvd, Suite 2210 Website: www.depuy.com Fax: 800-251-9864 Los Angeles, CA 90010, United States Year established: 1895 Email: [email protected] Phone: 213-300-7979 Website: www.deroyal.com Depuy Mitek, Inc. Year established: 1973 Directmed, Inc. 325 Paramount Dr. 150 Pratt Oval Raynham, MA 02767, United States Derron Surgical Instruments, Inc. Glen Cove, NY 11542, United States Phone: 508-880-8100 1055 Scherer Way Phone: 516-656-3377 Fax: 508-880-8122 Osprey, FL 34229, United States Email: [email protected] Email: [email protected] Phone: 941-918-8852 Website: www.directmed.com Website: www.depuyspine.com Fax: 941-918-8862 Year established: 1997 Year established: 1895 Email: [email protected] Year established: 1999 Disc-O-Tech Medical Technologies, Ltd. Depuy Orthopaedics, Inc. 3 Hasadnaot 700 Orthopaedic Dr. Design Standards Corp. Herzelia, Israel Warsaw, IN 46581, United States Ceda Industrial Park Phone: 972-9-951151 Phone: 574-267-8143 Charlestown, NH 03603, United States Fax: 800-473-3789 Phone: 603-826-7744 Disetronic Gmbh & Co. Kg Email: [email protected] Wittland 13 Website: www.depuyorthopaedics.com Devax, Inc. 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Förchenholzstr. 23 7030 Park Centre Dr. One Edwards Way Bad Tölz, 83646, Germany Salt Lake City, UT 84121, United States Irvine, CA 92614, United States Phone: 011-49-80418 Phone: 801-568-7000 Phone: 949-250-2500 Fax: 801-568-7711 Fax: 800-424-3278 Drb Technologies, Inc Email: [email protected] Website: www.edwards.com 3612 Chapel Rd., Suite B Website: www.dynatronics.com Year established: 1958 Newtown Square, PA 19073, United States Phone: 610-356-4258 Dynatronics Corp. Chattanooga Operations Efe Cons. & Imp. Ltda 6607 Mountain View Rd. Av. General Justo, 335-A sl., Centro Drg International, Inc. Ooltewah, TN 37363, United States Rio de Janeiro, RJ 20021-130, Brazil 1167 US Highway 22 E. Phone: 801-568-7000 Phone: 55-21-2240-5361 Mountainside, NJ 07092-2807, United States Fax: 55-21-2262-4866 Phone: 908-233-2079 E. Benson Hood Laboratories, Inc. 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E-Z-Em, Inc. 741 Peninsula Blvd. Sialkot, Pakistan 750 Summa Ave, Westbury, NY 11590, United States Hempstead, NY 11550, United States Phone: 92-432-56136 Phone: 516-333-8230 Phone: 516-292-7400 Website: www.ezem.com Fax: 516-292-7484 Exactech, Inc. Year established: 1962 Email: [email protected] 2320 N.W. 66 Court Website: www.finesurgical.com Gainesville, FL 32653, United States Fabrication Enterprises Inc. Year established: 1975 Phone: 352-377-1140 Post Office Box 1500 Fax: 800-392-2832 White Plains, NY 10602, United States Finebrand Co. Email: [email protected] Phone: 914-345-9300 3720 S. Santa Fe Ave. Website: www.exac.com Fax: 914-345-9800 Los Angeles, CA 90058, United States Year established: 1985 Email: [email protected] Phone: 323-588-3228 Website: www.FabricationEnterprises.com Email: [email protected] Year established: 1974 Website: www.finebrand.net Source: MDRWeb.com 218 Flexible Stenting Solutions Inc. Franz Maier Chir. 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Corp. 475 West 13th St, Ogden, UT 84404, United States Geen Healthcare Inc. 9609 Indianapolis Road Phone: 781-699-9068 931 Progress Ave. Ste.13 Fort Wayne, IN 46809, United States Website: www.fmcna.com Scarborough, ON M1G 3V5, Canada Phone: 260-747-4154 Phone: 416-439-2237 Email: [email protected] Friedrich Daniels Gmbh Fax: 416-439-6934 Website: www.fwmetals.com Neuenhofer Str. 7 Email: [email protected] Year established: 1970 Solingen, 42657, Germany Year established: 1994 Phone: 02-12-81 00 Fort Worth Eye Prosthetics, Inc. Genadyne Biotechnologies, Inc. 1350 South Main, #2450 Frimed Medizintechnik Gmbh 65 Watermill Lane Fort Worth, TX 76104, United States Wartenbergstr. 23 Great Neck, NY 11021, United States Phone: 817-429-8086 Tuttlingen, 78532, Germany Phone: 516-487-8787 Phone: 074-611-6178 Fortrad Eye Instruments Corp. General Hospital Supply Corp. 8 Franklin Road Fziomed, Inc. 2844 Gray Fox Rd. Mendham, NJ 07945, United States 231 Bonetti Drive Monroe, NC 28110, United States Phone: 973-543-2371 San Luis Obispo, CA 93401, United States Phone: 704-225-9500 Fax: 973-543-5446 Phone: 805-546-0610 Year established: 1979 Email: [email protected] Generic Medical Device, Inc. Website: www.fziomed.com 5727 Baker Way Nw, Suite 201 Foster Manufacturing Corp. Year established: 1996 Gig Harbor, WA 98332, United States 1652 Phillips Avenue Phone: 253-853-3594 Racine, WI 53403, United States G.U. Medical Ltd. Phone: 262-633-7073 841 Coronation Road Genesee Biomedical, Inc. Email: [email protected] London, NW10 7QJ, United Kingdom 1308 S. Jason St. Website: www.fostermfgcorp.com Phone: 004-418-1 96 Denver, CO 80223, United States Phone: 303-777-3000 Four Process, Ltd. Galix Biomedical Instrumentation, Inc. 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Phone: 508-586-8308 Gama, A.S. Route De Divonne 48 Fax: 508-588-6784 Prumyslova 2a Nyon, 1260, Switzerland Year established: 1936 Ceské Budejovice, 370 01, Czech Republic Phone: 41-223-62505 Phone: 212-601-1595 Frank Tanaka, Ocularist, Inc. Geneva Medical Inc. 3000 East Fletcher Ave., Suite 310 Gardner Denver Thomas Inc. 2571 Kaneville Court Tampa, FL 33613, United States 1419 Illinois Ave Geneva, IL 60134, United States Phone: 813-978-1142 Sheboygan, WI 53082, United States Phone: 630-232-2507 Phone: 920-457-4891 Frantz Medical Development Ltd. Email: [email protected] Genpore, A Division Of General Polymeric Corp. 7740 Metric Drive Website: www.gd-thomas.com 1136 Morgantown Road Mentor, OH 44060-4862, United States Year established: 1948 Reading, PA 19607, United States Phone: 440-255-1155 Phone: 610-374-5171 Email: [email protected] Gauthier Biomedical, Inc. 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Genx International Glenn Reams, Ocularist Grace Engineering Corp. 393 Soundview Road 610 South Floyd 34775 Potter St. Guilford, CT 06437, United States Louisville, KY 40202, United States Memphis, MI 48041-0202, United States Phone: 203-453-1700 Phone: 800-426-8995 Phone: 810-392-2181 Fax: 888-GEN-XNOW Email: [email protected] Glenn Reams, Ocularist Grace Manufacturing, Inc. Year established: 1996 2845 Farrell Crescent 614 SR 247 Owensboro, KY 42303, United States Russellville, AR 72802, United States Genzyme Corporation Phone: 800-426-8995 Phone: 479-968-5455 1125 Pleasantview Terrace Fax: 479-968-5460 Ridgefield, NJ 07657-2397, United States Glenn Reams, Ocularist Email: [email protected] Phone: 617-252-7500 221 N.w. Mcnary Court Website: www.gracemfg.com Lee’s Summit, MO 64086, United States Year established: 1966 Georg Leibinger Medizintechnischer Phone: 800-426-8995 Apparatebau Grace Medical, Inc. 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Highland Dr., #303 Camp Hill, PA 17011-1706, United States Salt Lake City, UT 84106, United States Greenwald Surgical Co., Inc. Phone: 717-761-1170 Phone: 801-746-0208 2688 Dekalb St. Fax: 800-451-5797 Gary, IN 46405, United States Email: [email protected] Global Services Group Phone: 219-962-1604 350 Mclaws Circle, Suite:2 Gilbert Surgical Instruments, Inc. Williamsburg, VA 23185, United States Greylor Co. 115 Harding Ave., Bellmar, NJ 08031-2413, United States Phone: 757-220-8282 2340 Andalusia Blvd. Phone: 856-933-2770 Cape Coral, FL 33909, United States Email: [email protected] Globalmed Inc. Phone: (239) 574-2011 Website: www.gilbertsurgical.com 155 N. Murray St., Trenton, ON K8V-5R5, Canada Email: [email protected] Phone: 613-394-9844 Website: www.greylor.com Gilliam Enterprises, Llc Email: [email protected] 5830 Briercliff Rd. Website: www.globalmedinc.com Greystone Of Lincoln, Inc. Knoxville, TN 37918, United States Year established: 1999 7 Wellington Rd. Phone: 866-655-0517 Lincoln, RI 02865, United States Globus Medical Inc. Phone: 401-333-0444 Gimmi Gmbh, Rudolf Valley Forge Business Center, 2560 General Junkers Str 1 Armistead Ave., Audobon, PA 19403, United States Gribi Ag Belp Tuttlingen, 78532, Germany Phone: 610-930-1800 Huhnerbubelstrasse 59 Phone: 7461/96590-0 Fax: 610-930-2042 Belp, 3123, Switzerland Fax: 7461/96590-33 Email: [email protected] Phone: 31/819-5757 Email: [email protected] Website: www.globusmedical.com Fax: 31/819-0282 Year established: 2003 Email: [email protected] Gip Medizin Technik Gmbh Website: www.gribi.ch Stockertweg 10 Glucotec, Inc. Rohrdorf, 83101, Germany 665 north academy street Griffin Laboratories Phone: 49-803-2973 Greenville, SC 29601, United States 43391 Business Park Dr., #c5 Phone: 864-370-3297 Rancho California, CA 92590, United States Glacier Cross, Inc. Phone: 800-330-5969 1694 Whalebone Dr. Gml, Inc. Kalispell, MT 59901, United States 500 Oak Grove Pkwy. 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Fritz-berne-str. 40 Broomfield, CO 80021, United States Indianapolis, IN 46256, United States Muenchen, 81241, Germany Phone: 303-443-7500 Phone: 317-840-3816 Phone: 89/839-4090 Fax: 303-443-7501 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.LifeMedicalLLC.com Website: www.lohmeier.com Website: www.lanx.com Year established: 2003 Year established: 2003 Lonza Walkersville, Inc. Lifecore Biomedical, Inc. 8830 Biggs Ford Rd. Larkotex Company 3515 Lyman Blvd. Walkersville, MD 21793, United States 1002 Olive St. Chaska, MN 55318, United States Phone: 201-316-9200 Texarkana, TX 75501-0449, United States Phone: 952-368-4300 Email: [email protected] Phone: 903-793-4647 Email: [email protected] Website: www.lonza.com Fax: 903-793-4650 Website: www.lifecore.com Year established: 1984 Year established: 1965 Ldb Medical, Inc. Lots Corp. 2909 Langford Road, Suite 500B Life-Like Laboratory 10977 E. 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Source: MDRWeb.com 228 M.E.E.I. Mfg. Manufacturing & Research, Inc.(Dba Mri Masel Co., Inc. Claes H Dohlman, Md Room 550l, Meei, 5th Floor Medical) 2701 Bartram Road Boston, MA 02114, United States 4700 S. Overland Drive Bristol, PA 19007-6810, United States Phone: 941-492-2560 Tucson, AZ 85714, United States Phone: 215-785-1600 Phone: 520-882-7794 Fax: 800-423-8227 M.F. Elahi & Co. (Ep) Pvt. Ltd. Email: [email protected] Email: [email protected] # 309.102.30 Wazirabad Road, Kotli Behram Website: www.mrimedical.com Website: www.maselortho.com Sialkot, 22161, Pakistan Year established: 1986 Year established: 1977 Phone: 92-432-55467 Mapa Gmbh Gummi- Und Plastikwerke Mast Biosurgery Usa Inc. M.J. Instruments Company (Pvt) Ltd. Industriestr. 21-25 6749 Top Gun St., Suite 108 Small Industries Estate Zeven, 27404, Germany San Diego, CA 92121, United States Sialkot, 22161, Pakistan Phone: 858-550-8050 Phone: 92-432-25662 MAQUET 15 Law Drive Master Craft Labs M/S. Perfectra Instruments Fairfield, NJ 07004, United States 102 Main St., P.o. Box 11 Bonken Rd., Pacca Garah, Sialkot Phone: 201-391-8100 Bethel, MN 55005, United States Sialkot Punjab, Pakistan Fax: 800-288-2121 Phone: 800-233-1413 Phone: 043-2-272125 Website: www.datascope.com Year established: 1964 Masterdent Ltda. Mabis Healthcare Inc. Carrera 42 , 39 Sur 90 1931 Norman Drive Maquet Cardiovascular LLC Envigado, Colombia Waukegan, IL 60085, United States 45 Barbour Pond Dr. Phone: 574-332-9345 Phone: 800-526-4753 Wayne, NJ 07470, United States Website: www.mabisdmi.com Phone: 888-880-2874 Mattes & Schwarz Year established: 1992 Email: [email protected] Kronenstrasse 7 Website: www.maquet.com Tuttlingen, 78532, Germany Macropore Biosurgery, Inc. Year established: 2003 Phone: 7461/969702-0 6740 Top Gun St. Fax: 7461/969702-9 San Diego, CA 92121-4148, United States Maquet Puerto Rico Inc. 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Source: MDRWeb.com 231 Medtronic Vascular Merit Medical Systems, Inc. Microline Pentax, Inc. 710 Medtronic Parkway, L100 1111 South Velasco 800 Cummings Center, Suite # 166t Minneapolis,, MN 55432-5604, United States Angleton, TX 77515, United States Beverly, MA 01915, United States Phone: (763) 514-4000 Phone: 801-253-1600 Phone: 978-922-9810 Fax: 1-800-633-8766 Email: [email protected] Website: www.medtronic.com Merlin’s Medical Supply Website: www.microlinepentax.com 699 Mobil Avenue, Camarillo, CA 93010, United States Year established: 1987 Medtronic Xomed, Inc. Phone: 805-388-7669 950 Flanders Rd. Fax: 800-639-9322 Microma Medizintechnik Mystic, CT 06355, United States Email: [email protected] Hardtstr. 19 Phone: 800-637-6235 Year established: 1985 Irndorf, 78597, Germany Website: www.merocel.com Phone: 074-66-3 88 Year established: 1974 Merlyn Pharmaceuticals, Inc. Medtronic Xomed, Inc. 8175 Kroger Farm Rd. Micromanipulator Co., Inc., The 6743 Southpoint Drive North Cincinnati, OH 45243-1639, United States 1555 Forrest Way Jacksonville, FL 32216-0980, United States Phone: 513-831-3005 Carson City, NV 89706-0448, United States Phone: 904-296-9600 Email: [email protected] Phone: 775-882-2400 Fax: 800-874-5797 Website: merlynp.homestead.com Fax: 775-882-7694 Email: [email protected] Email: [email protected] Website: www.xomed.com Metasys Medizintechnik Gmbh Website: www.micromanipulator.com Year established: 1999 A-6063 Rum, Florianistr 3 Year established: 1956 Oberhaching, 82041, Germany Medtronic, Inc. Phone: 20/54-20-0 Micromeccanica Di Bianchi Lucia 710 Medtronic Parkway Fax: 20/54-20-7 Via G Di Vittorio 10/12 Minneapolis, MN 55432-5604, United States Email: [email protected] Misinto, 20020, Italy Phone: 763-514-4000 Phone: -96683 Fax: 800-633-8766 Mettler Electronics Corp. Website: www.medtronic.com 1333 S. Claudina Street Micromed Technology, Inc. Year established: 1949 Anaheim, CA 92805-6235, United States 8965 Interchange Dr. Phone: 714-533-2221 Houston, TX 77054, United States Mekanika, Inc. Fax: 800-854-9305 Phone: 713-838-9210 3998 Fau Blvd., Suite 210 Email: [email protected] Website: www.micromedtech.com Boca Raton, FL 33431, United States Website: www.mettlerelectronics.com Year established: 1996 Phone: 561-417-7244 Year established: 1957 Micromedics Mentor Corp. Michael’s France 1270 Eagan Industrial Road 201 Mentor Drive 55 Avenue Sainte Foy St. Paul, MN 55121-1385, United States Santa Barbara, CA 93111, United States Neuilly Sur Seine, 92200, France Phone: 651-452-1977 Phone: 805-879-6000 Phone: 33-146-37666 Fax: 800-624-5662 Fax: 800-525-0245 Email: [email protected] Email: [email protected] Michele Cannova Chirurgische Instrumente Website: www.micromedics.com Website: www.mentorcorp.com Stockacher Str. 108 Year established: 1982 Year established: 1969 Tuttlingen, 78532, Germany Micron Precision Engineering, Inc.

Mentor Texas, Inc. Micor, Inc. 939 Evening Shade Dr 3041 Skyway Circle North 2855 Oxford Blvd. San Pedro, CA 90731, United States Irving, TX 75038, United States Allison Park, PA 15101-2455, United States Phone: 310-874-4963 Phone: 972-252-6060 Phone: 412-487-1113 Website: www.mentorcorp.com Email: [email protected] Microsurgical Laboratories Year established: 1969 Website: www.micorinc.com 11333 Chimney Rock Road, Suite 120 Year established: 1984 Houston, TX 77035, United States Mercator Medsystems, Inc. Phone: 713-723-6900 1670 Alvarado Street, Suite 4 Micrins Surgical Instruments, Inc. Fax: 713-723-6906 San Leandro, CA 94577, United States 28438 Ballard Drive Email: [email protected] Phone: 510-614-4550 Lake Forest, IL 60045, United States Website: www.wexlersurgical.com Email: [email protected] Phone: 847-549-1410 Year established: 1991 Website: www.mercatormed.com Fax: 847-549-1510 Email: [email protected] Microvention, Inc. 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Source: MDRWeb.com 236 Overseas Medical Supplies (Uk) Ltd Paradigm Biodevices, Inc. Pedia Pals, Llc 12 Cumberland Avenue 800 Hingham St. Suite 102n, Suite 207S 965 Highway 169 N. London, NW10 7QL, United Kingdom Rockland, MA 02370, United States Plymouth, MN 55441, United States Phone: 0208 965 9711 Phone: 781-982-9950 Phone: 763-546-4161 Email: [email protected] Fax: 781-982-9008 Fax: 888-733-4272 Website: www.overseasmedical.com Email: [email protected] Email: [email protected] Website: www.paradigmbiodevices.com Website: www.pedipals.com Oxy-View, Inc. Year established: 1997 Year established: 1998 109 Inverness Dr. East, Ste. C Englewood, CO 80112-5105, United States Paragon Medical, Inc. Pedinol Pharmacal, Inc. 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Quatro Composites Raymedica, Llc Renew Biocare Corp. 13250 Gregg St. Suite A-1 9401 James Ave. South, Suite 120 1001 Bayhill Dr., 2nd Fl Poway, CA 92064, United States Minneapolis, MN 55431, United States San Bruno, CA 94066, United States Phone: 858-513-4300 Phone: 952-885-0500 Phone: 415-367-3646 Fax: 858-513-3628 Email: [email protected] Email: [email protected] Year established: 1991 Website: www.quatrocomposites.com Year established: 2004 Source: MDRWeb.com 239 Renick Ent., Inc. Rickman Tool, Inc. Rocky Mountain Anaplastology, Inc. 1211 West 13th St. 1202 E. 4th Street 3405 South Yarrow St., Suite C Riviera Beach, FL 33404, United States Rochester, IN 46975-0547, United States Denver, CO 80227, United States Phone: 561-863-4183 Phone: 574-223-8198 Phone: 303-973-8482 Email: [email protected] Email: [email protected] Website: www.rei-usa.com Website: www.rickmantool.com Rogers Foam Corp. 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Select Medical Systems Shelhigh, Inc. Signus Medizintechnik Gmbh 30 Winter Sport Lane, PO Box 966 650 Liberty Ave., Union, NJ 07083, United States Rannenbergring 54 Williston, VT 05495, United States Phone: 908-206-8706 Alzenau, 63755, Germany Phone: 802-862-1017 Phone: 011-49-6023 Fax: 800-441-1973 Shoney Scientific, Inc. Email: [email protected] West 223 North 720 Saratoga Drive, Suite 120 Silver Plus Corp. Website: www.selectmedical.com Waukesha, WI 53186, United States Mohammad Pura Year established: 1986 Phone: 262-970-0170 Sialkot, 22161, Pakistan Website: www.shoney.com Phone: 432-593-360 Semadeni Ag Year established: 1986 Taegetlistr 35-39 Sim Medical Sales Ostermundigen, 3072, Switzerland Showa Ika Kogyo Co. Ltd. PO BOX 0895 Phone: 31/931-3531 9th Fl. 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Website: www.simpexmedical.com 970 Lake Carillon Dr., Suite 110 Societe Des Ceramiques Techniques Year established: 1991 Saint Petersburg, FL 33716, United States Route De Bordeaux Phone: 727-392-1261 Bazet, 65460, France Simplicity Orthopedic Solutions, Llc Fax: 800-876-1261 Phone: 33-62-379291 77 Main St., Second Floor Website: global.smith-nephew.com Andover, MA 01810, United States Sodipromm Sarl Phone: 866-623-0033 Smith & Nephew, Inc., Endoscopy Division Lotissement La Reybaude 150 Minuteman Road Saignon, 84400, France Skeletal Kinetics, Llc Andover, MA 01810-1031, United States Phone: 011-334-9004 10201 Bubb Rd. Phone: 978-749-1000 Cupertino, CA 95014, United States Fax: 800-343-8386 Sohniks Endoscopy, Inc. Phone: 408-366-5000 Email: [email protected] 930 Blue Gentian Rd., Suite 1400 Website: www.endo.smith-nephew.com Eagan, MN 55121, United States Skil-Care Corp. Phone: 651-452-4059 29 Wells Avenue Smith & Nephew, Inc., Endoscopy Division Yonkers, NY 10701-6605, United States 130 Forbes Blvd. Solaris, Inc. Phone: 914-963-2040 Mansfield, MA 02048, United States 6737 West Washington St., Suite 3260 Fax: 800-431-2972 Phone: 978-749-1000 West Allis, WI 53214, United States Email: [email protected] Fax: 800-343-8386 Phone: 414-918-9180 Website: www.skil-care.com Website: www.endo.smith-nephew.com Year established: 1978 Solatch International Smith & Nephew, Mexico Inc. P.o. Box 2317, Wazirabad Rd. Small Bone Innovations, Inc. San Francisco Cuautlalpan #101 Sialkot, Pakistan 1380 S. Pennsylvania Avenue Naucalpan, Edo. De Mexico, Mexico Phone: 030-374-8352 Morrisville, PA 19067, United States Phone: 901-396-2121 Phone: (215) 428-1791 Solatch Sons Fax: (866) SBi-TIPS Smith And Nephew Medical Ltd. P.o. Box 1193, Christian Town Email: [email protected] 101 Hessle Rd. 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Smith & Nephew, Inc. 330 Corporate Woods Dr. Soper Brothers & Associates 970 lake carillon dr., suite 110 Vernon Hills, IL 60061, United States 1213 Hermann Dr., Suite 320 saint petersburg, FL 33716, United States Phone: 847-793-0135 Houston, TX 77004, United States Phone: 727-392-1261 Phone: 713-521-1263 Fax: 800-876-1261 Smiths Medical OEM Website: www.smith-nephew.com 5200 Upper Metro Place, Suite 200 Sorin Group Usa Year established: 1856 Dublin, OH 43017, United States 14401 W. 65th Way Phone: 614-210-7300 Arvada, CO 80004-3599, United States Fax: 800-258-5361 Phone: 303-425-5508 Email: [email protected] Fax: 800-289-5759 Website: www.smiths-medical.com Email: [email protected] Website: www.soringroup-usa.com Year established: 1999 Source: MDRWeb.com 243 Southside Biotechnology Sphinx Tools Ltd. St. Jude Medical Atrial Fibrillation (Endocardial 8780 Tyler Blvd., Mentor, OH 44060, United States Industriestrasse 6 Solutions) Phone: 440-974-4074 Biberist, 4562, Switzerland 1350 Energy Ln, Suite 110 Email: [email protected] Phone: 41-32-671 21 St. Paul, MN 55108-5254, United States Year established: 1988 Phone: 651-523-6900 Spinal Designs Intl. Fax: 800-374-8038 Southwest Artificial Eyes, Inc. 708 Division Ave S. Email: [email protected] P.O. Box 100636 Cavalier, ND 58220, United States Website: www.sjm.com San Antonio, TX 78201, United States Phone: 701-265-4927 Phone: 210-737-3937 St. Jude Medical Cardiac Rhythm Management Spinal Elements, Inc. Div. Sparton Corporation 2744 Loker Ave. W. Suite 100 15900 Valley View Ct. 22740 Lunn Road Carlsbad, CA 92008, United States Sylmar, CA 91342-3577, United States Strongsville, OH 44149, United States Phone: 760-607-0121 Phone: 818-362-6822 Phone: 440-878-4630 Fax: 800-777-2237 Website: sparton.com Spinal Kinetics, Inc. Website: www.sjm.com 595 N Pastoria Avenue Specialized Health Products International, Inc. Sunnyvale, CA 94085, United States St. Jude Medical Neuromodulation Division 585 W. 500 S., Bountiful, UT 84010, United States Phone: 609-254-3999 6901 Preston Rd. Phone: 801-298-3360 Plano, TX 75024, United States Fax: 800-306-3360 Spinal Traction Products, Llc. Phone: 972-309-8000 Email: [email protected] 5 Lake Forest Ct. East Fax: 800-727-7846 Website: www.shpi.com St. Charles, MO 63301, United States Email: [email protected] Year established: 1993 Phone: 636-947-9086 Website: www.ans-medical.com Year established: 1981 Specialty Manufacturing Co., The Spine Smith Partners L.P. 5858 Centerville Rd. 8140 N. Mopac, Bldg Ii, Suite 120 St. Jude Medical Sweden Ab St. Paul, MN 55127-6804, United States Austin, TX 78759, United States veddestavagen 19 Phone: 651-653-0599 Phone: 512-206-0770 jarfalla, Stockholm 175 84, Sweden Email: [email protected] Phone: 08-474-40-00 Website: www.specialtymfg.com Spine Wave, Inc. Email: [email protected] Year established: 1901 Two Enterprise Dr., Suite 302 Website: www.sjm.se Shelton, CT 06484, United States Specialty Surgical Products, Inc. Phone: 203-944-9494 St. Jude Medical, Inc. 1131 North U.S. Hwy. 93 One St. Jude Medical Drive Victor, MT 59875, United States Spinecraft Llc St. Paul, MN 55117-9983, United States Phone: 406-961-0102 2215 Entreprise Dr. Phone: 651-483-2000 Email: [email protected] Westchester, IL 60154, United States Fax: 800-328-9634 Website: www.ssp-inc.com Phone: 708-531-9700 Website: www.sjm.com Year established: 1997 Year established: 1976 Spineworks Medical Inc. Spectranetics Corp. 1735 North First Street, Suite 245 Staar Surgical Co. 9965 Federal Drive San Jose, CA 95112, United States 1911 Walker Ave. Colorado Springs, CO 80921, United States Phone: 408-986-8950 Monrovia, CA 91016-4846, United States Phone: 719-447-2000 Phone: 626-303-7902 Fax: 800-633-0960 Spinus, Llc Fax: 800-292-7902 Email: [email protected] 8 Merrill Industrial Dr. Email: [email protected] Website: www.spectranetics.com Hampton, NH 03842, United States Website: www.staar.com Year established: 1984 Phone: 603-758-1444 Year established: 1982

Spectrascience, Inc. Spiracle Technology Standard Imaging, Inc. 11568-11 Sorrento Valley Rd. 16520 Harbor Blvd., Unit D 3120 Deming Way San Diego, CA 92121, United States Fountain Valley, CA 92708, United States Middleton, WI 53562, United States Phone: 858-847-0200 Phone: 714-418-1091 Phone: 608-831-0025 Email: [email protected] Email: [email protected] Website: www.spectrascience.com Website: www.spiracle.com Standard Instrumentation, Div. Preiser Scientific 94 Oliver St. Spectrum Designs Medical, Inc. Spirax Sarco, Inc. St. Albans, WV 25177, United States 6387-B Rose Lane 1150 Nortpoint Blvd. Phone: 304-727-2902 Carpinteria, CA 93013, United States Blythewood, SC 29016, United States Fax: 304-727-2932 Phone: 805-684-7678 Phone: 803-714-2000 Email: [email protected] Fax: 800-239-6399 Fax: 800-575-0394 Website: www.preiser.com Email: [email protected] Email: [email protected] Year established: 1924 Website: www.spectrumdesignsmedical.com Website: www.spiraxsarco.com/us Year established: 1987 Year established: 1983 Stars 6630 Exchequer Drive Spectrum Laboratories, Inc. Sport Tech, Inc. Baton Rouge, LA 70809, United States 18617 Broadwick St. 391 Ridge Lee Drive Phone: 225-752-4912 Rancho Dominguez, CA 90220, United States Charlottesville, VA 22903, United States Fax: 225-752-8523 Phone: 310-885-4600 Phone: 434-982-5752 Email: [email protected] Fax: 800-634-3300 Website: www.scoliosis.com Email: [email protected] St. Jude Medical Atrial Fibrillation Website: www.spectrumlabs.com 6500 Wedgwood Rd. Sta-Sof Breast Compressor-Clamp Year established: 1970 Maple Grove, MN 55311, United States 10571 Wyton Dr. Phone: 763-383-0900 Los Angeles, CA 90024, United States Speedent Dental Supplies Fax: 800.748.7335 Phone: 310-470-8798 9591 Central Ave. Email: [email protected] Montclair, CA 91763, United States Website: www.sjm.com State Trading Corporation Of India, Ltd. Phone: 800-706-0644 350 5th Ave., Ste. 1124, 11th Fl. St. Jude Medical Atrial Fibrillation New York, NY 10118, United States Spencer Italia S.R.L. 14901 DeVeau Pl. Phone: 212-244-3317 Strada Cavi, 7 Minnetonka, MN 55345-2126, United States Email: [email protected] Collecchio, PR 43034, Italy Phone: 612-933-4700 Phone: 0521/5411 Fax: 800-328-3873 Email: [email protected] Website: www.sjm.com Website: www.spencer.it Source: MDRWeb.com 244 Steeger Usa, Llc Storz Endoskop Gmbh Stryker Pacific 2353 Highway 292 Kreuzgutweg 22 20th Floor, One Pacific Place, 88 Queensway Inman, SC 29349, United States Schaffhausen, 8207, Switzerland Hong Kong Phone: 864-472-7000 Phone: 49-746-17080 Phone: 852-2840-4400 Fax: 864-472-7073 Fax: 852-2804-6303 Email: [email protected] Storz Gmbh & Co., Karl Website: www.pacific.stryker.com Website: www.steegerusa.com Mittelstr 8 Tuttlingen, 78532, Germany Stryker Puerto Rico, Ltd. Steiner Laboratories Phone: 7461/7080 Hwy. 3, Km. 131.2, Las Guasimas Ind. Park 590 Farrington Hwy., #1010 Suite 7 Fax: 7461/708-105 Arroyo, PR 00714, United States Kapolei, HI 96707, United States Email: [email protected] Phone: 939-307-2500 Phone: 808-371-2700 Website: www.karlstorz.com Stryker Spine Stelkast Company Straumann Manufacturing, Inc. 2 Pearl Ct, Allendale, NJ 07401, United States 200 Hidden Valley Rd. 60 Minuteman Rd. Phone: 201-760-8000 Mcmurray, PA 15317, United States Andover, MA 01810, United States Fax: 866-457-7463 Phone: 724-941-6368 Phone: 978-747-2575 Website: www.stryker.com

Stephen Tobias Hearing Center Strenumed, Inc. Stryker Trauma Ag (Sa) 382 Quincy Avenue 1833 Portola Road, Suite K Bohnackerweg 1 Quincy, MA 02169, United States Ventura, CA 93003, United States Selzach, 2545, Switzerland Phone: 617-770-3395 Phone: 805-477-1000 Phone: 041-32-641-6666 Fax: 805-477-1367 Email: [email protected] Stereotaxis, Inc. Email: [email protected] Website: www.strykertrauma.org 4320 Forest Park Ave., Suite 100 Website: www.strenumed.com Year established: 1941 St. Louis, MO 63108, United States Year established: 1995 Phone: 314-615-6940 Stryker Trauma Gmbh Fax: 866-646-2346 Striker Corp. Prof.-Kuentscher-Strasse 1-5 Email: [email protected] 2825 Airview Boulevard Schoenkirchen, 24232, Germany Website: www.stereotaxis.com Kalamazoo, MI 49002, United States Phone: 049-4348-702-0 Phone: 269-385-2600 Fax: 049-4348-702-17 Stericon, Inc. 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Year established: 1941 Tuttlingen, 78532, Germany Ham Lake, MN 55304, United States Phone: 074-61--1533 Phone: 763-755-9516 Stryker Endoscopy Fax: 800-328-7958 5900 Optical Ct Sufal Industries (Pvt) Ltd. Email: [email protected] San Jose, CA 95138, United States 25/c, S.i.e. Website: www.aspensurgical.com Phone: 408-754-2000 Sialkot, Punjab, Pakistan Year established: 1982 Fax: 800-754-2505 Phone: -55705 Website: www.strykerendo.com Stern Inc., Walter Sukol Scientific, Inc. 68 Sintsink Drive East, P.O. Box 571 Stryker Gmbh 8311 Nw 68th Street Port Washington, NY 11050-0105, United States Dr. Homer Stryker Platz 1 Miami, FL 33166, United States Phone: 516-883-9100 Duisburg, 47228, Germany Phone: 305-468-0085 Phone: 49 (0)2065 837 Sterngold Fax: 49 (0)2065 837 Sulzer Ortopadie Ltd 23 Frank Mossberg Drive, PO Box 2967 Email: [email protected] Grabenstrasse 25 Attleboro, MA 02703-0967, United States Website: www.stryker.de Baar, 6341, Switzerland Phone: 508-226-5660 Phone: 41/768-3232 Fax: 800-243-9942 Stryker Howmedica Osteonics Fax: 41/761-9200 Email: [email protected] 325 Corporate Drive Email: [email protected] Website: www.sterngold.com Mahwah, NJ 07430, United States Website: www.sulzerothoeu.com Year established: 1897 Phone: 201-831-5000 Website: www.stryker.com Summit Business Products, Inc. Steven R. Young Ocularist, Inc. 995 E. Business 30 411 30th Street, Suite 512 Stryker Instruments, Instruments Div. Columbia City, IN 46725, United States Oakland, CA 94609, United States 4100 East Milham Ave. Phone: 260-244-1820 Phone: 510-836-2123 Kalamazoo, MI 49001, United States Phone: 800-253-3210 Suneva Medical, Inc. Stille Surgical Ab Email: [email protected] 5870 Pacific Center Blvd. Industrigatan 2a Website: www.instrumedinc.com San Diego, CA 92121, United States Stockholm, 112 46, Sweden Phone: 858-550-9999 Phone: 46-858-8 580 Stryker Medical Email: [email protected] 3800 E. Centre Avenue Website: www.sunevamedical.com Stoehr Medizintechnik Portage, MI 49002, United States Year established: 2009 Bahnhofstr. 13 Phone: 269-329-2100 Frittlingen, 78665, Germany Fax: 269-329-2213 Sunlite Plastics, Inc. Phone: 074-26-70 72 Website: www.stryker.com W194 N11340 McCormick Dr. Year established: 1941 Germantown, WI 53022, United States Stone Instruments Co. Phone: 262-253-0600 Commissioner Rd. 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Largo, FL 33773, United States Sheffield, Sth Yorks S6 2BJ, United Kingdom St. Paul, MN 55114, United States Phone: 727-530-7099 Phone: 114/234-4231 Phone: 651-796-7300 Fax: 800-433-2797 Fax: 114/231-4966 Fax: 800-255-4018 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.sunmedusa.com Website: www.swann-morton.com Website: www.synovissurgical.com Year established: 1932 Year established: 1985 Sunmed Usa Llc. 841 Apollo Street, Suite 334 Symbios Medical Products, Llc Synthes (Usa) El Segundo, CA 90245, United States 7301 Georgetown Rd, Suite 150 35 Airport Road Phone: 310-531-8222 Indianapolis, IN 46268, United States Horseheads, NY 14845, United States Phone: 317-225-4447 Phone: 610-719-5000 Superior Products, Inc. Email: [email protected] 3786 Ridge Rd. Symmetry Medical Usa, Inc Website: us.synthes.com Cleveland, OH 44144, United States 111 N. 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State Rd. 15 West Chester, PA 19380, United States Warsaw, IN 46582, United States Phone: 719-481-5300 Surgica Corporation Phone: 574-268-2252 Website: www.synthes.com PO Box 723, #4 Website: www.symmetrymedical.com Pollock Pines, CA 95726, United States Year established: 1976 Synthes San Diego Phone: 916-933-5056 6244 Ferris Square, Suite B Fax: 800-979-5090 Symmetry Tnco San Diego, CA 92121-3239, United States Email: [email protected] 15 Colebrook Blvd. Phone: 858-452-1266 Website: www.surgica.com Whitman, MA 02382, United States Year established: 1997 Phone: 781-447-6661 T & L Sharpening, Inc. Fax: 781-447-2132 2663 S. Freeman Rd., P.o. Box 338 Surgical Implant Generation Network (Sign) Email: [email protected] Monticello, IN 47960, United States 451 Hills St. Website: www.tnco-inc.com Phone: 574-583-3868 Richland, WA 99354, United States Year established: 1964 Phone: 509-371-1107 Tacpro, Inc. 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Goregaon West, O’Fallon, MO 63368, United States 535 Encinitas Blvd, Suite 109 Mumbai, Maharashtra 400104, India Phone: 636-939-5100 Encinitas, CA 92024, United States Phone: 91-22-28760703 Fax: 800-600-0565 Phone: 760-943-0100 Email: [email protected] Website: www.synergeticsusa.com Email: [email protected] Website: www.surgimedik.com Year established: 1991 Website: www.autodose.com Year established: 1998 Year established: 1997 Synovis Life Technologies, Inc Sutura, Inc. 2575 University Ave. W Tapco Medical, Inc. 17080 Newhope St. St. Paul, MN 55114, United States 23981 Craftsman Road Fountain Valley, CA 92708, United States Phone: 651-796-7300 Calabasas, CA 91302, United States Phone: 714-437-9801 Fax: 800-255-4018 Phone: 818-225-5376 Website: www.synovislife.com Email: [email protected] Svelte Medical Systems Inc. Year established: 1994 675 Central Avenue, Suite 2 Synovis Micro Companies Alliance, Inc. New Providence, NJ 07974, United States 439 Industrial Ln. 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Source: MDRWeb.com 246 Taut, Inc. Tekia, Inc. Teufel Gmbh & Co., Carl 2571 Kaneville Ct. 17 Hammond Street, Suite 414 Tuttlinger St. 30 Geneva, IL 60134, United States Irvine, CA 92718, United States Liptingen, D-78576, Germany Phone: 630-232-2507 Phone: 949-699-1300 Phone: 7465/1022 Fax: 800-231-8288 Email: [email protected] Fax: 7465/1024 Email: [email protected] Website: www.tekia.com Email: [email protected] Website: www.taut.com Year established: 1995 Website: www.carl-teufel.de

Tava Surgical Instruments Teknimed Sa Texas Eye Prosthetics Llc 4837 McGrath St., Ste. J 8 Rue Du Corps Franc Pommies 4203 Montrose Blvd., Suite 380 Ventura, CA 93003, United States Vic En Bigorre, 65500, France Houston, TX 77006, United States Phone: 805-650-5209 Phone: 512-834-6235 Phone: 713-524-1001 Email: [email protected] Email: [email protected] Website: www.tavasurgical.com Teleflex Medical Website: www.texaseyeprosthetics.com Year established: 1977 2917 Weck Drive Research Triangle Park, NC 27709, United States Texas Medical Industries, Inc. Taylor Medical Products Phone: 919-544-8000 1409 Industrial Drive 200 Saint Francis Dr. #114 Fax: 800-334-9751 Royse City, TX 75189-9559, United States Bradford, PA 16701-2865, United States Website: www.teleflexmedical.com Phone: 972-636-9556 Phone: 814-362-2183 Fax: 972-635-9539 Telios Pharmaceuticals Email: [email protected] Tds U-Best Dental Technology 105 Morgan Lane Website: www.tmiunited.com 2941 E. Miraloma Ave. #6 & 7 Plainsboro, NJ 08536, United States Year established: 1968 Anaheim, CA 92806, United States Phone: 609-275-0500 Phone: 714-666-2288 Fax: 800-762-1574 Texas Orthopaedic Products & Services, L.L.C. 805 Riding Club Road, P.O. BOX 190 Team Technologies, Inc. Telos Medical Equipment (Austin & Assoc., Inc.) Rockwall, TX 75087-2193, United States 5949 Commerce Blvd. 1109 Sturbridge Road Phone: 972-772-8776 Morristown, TN 37814, United States Fallston, MD 21047-1905, United States Fax: 972-772-1930 Phone: 423-587-2199 Phone: 410-877-3029 Website: topsproducts.com Fax: 410-877-0544 Tecan Systems Email: [email protected] Tex-Care Medical 2450 Zanker Rd. Website: www.telosmedical.com 2908 Alamance Road San Jose, CA 95131, United States Burlington, NC 27215, United States Phone: 408-953-3100 Tennessee Medical Equipment, Inc. Phone: 336-570-5870 Fax: 800-231-0711 4637 Hwy 19 East Fax: 336-226-7220 Email: [email protected] Ripley, TN 38063, United States Email: [email protected] Website: www.tecan.com Phone: 731-635-2119 Website: www.texcaremedical.com

Technical Products, Inc. Terumo Cardiovascular Systems (Tcvs) Tfx Medical Oem 805 Marathon Parkway, Suite 150 125 Blue Ball Road 50 Plantation Drive Lawrenceville, GA 30045, United States Elkton, MD 21921, United States Jaffrey, NH 03452, United States Phone: 770-236-8452 Phone: 410-398-8500 Phone: 603-532-7706 Fax: 800-226-8434 Fax: 800-283-7866 Fax: 800-548-6600 Email: [email protected] Website: www.terumo-cvs.com Email: [email protected] Website: www.tpi-ga.com Year established: 1921 Website: www.tfx.com Year established: 1967 Year established: 1981 Terumo Cardiovascular Systems (Tcvs) Technodent Industries 28 Howe St. The Eye Concern, Inc. 62 Mozang Rd. Ashland, MA 01721, United States 1450 S. Dobson Rd., Suite #a-206 Lahore, Pakistan Phone: 508-881-4858 Mesa, AZ 85202, United States Phone: 042-637-1946 Fax: 800-283-7866 Phone: 480-962-5841 Website: www.terumo-cvs.com Tecno Instruments (Pvt) Ltd. Year established: 1921 The Fazex Co. 316-C Small Idustrial Estate Po Gohadpur Sialkot, Punjab 51340, Pakistan Terumo Cardiovascular Systems, Corp Sialkot, 22161, Pakistan Phone: 432/552-723 6200 Jackson Rd. Fax: 432/552-396 Ann Arbor, MI 48103-9300, United States The Olympus Optical Co. Email: [email protected] Phone: 734-663-4145 22-2 Nishi-Shinjuku, 1-Chome, Shinju-Ku Website: www.tecno.com.pk Fax: 800-521-2818 Tokyo, Japan Website: www.terumo-cvs.com Phone: 81--3-3340-2 Tegra Medical Inc. Year established: 1921 9 Forge Park The Pettibon System Franklin, MA 02038, United States Terumo Medical Corporation 3214 50th St CT, Suite 102C Phone: 508-541-4200 950 Elkton Blvd., P.O.Box 605 Gig Harbor, WA 98335, United States Email: [email protected] Elkton, MD 21921, United States Phone: (888) 774-6258 Website: www.tegramedical.com Phone: 410-392-8500 Fax: 800-738-4266 Year established: 2007 Fax: 800-283-7866 Website: www.pettibonsystem.com Website: www.terumomedical.com Year established: 1987 Tegrant Corporation, Thermosafe Brands Year established: 1921 3930 Ventura Drive Suite 450 The Saunders Group Arlington Heights, IL 60084, United States Tetra Medical Supply Corp. 4250 Norex Drive Phone: 847-398-0110 6364 W. 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Tmp Technologies, Inc. 640 South Rockford Dr. 101 Rose Hill Industrial Park 1200 Northland Avenue Tempe, AZ 85281, United States Rose Hill, VA 24281, United States Buffalo, NY 14215, United States Phone: 480-281-4400 Phone: 865-362-6022 Phone: 716-895-6100 Email: www.techgroup.com Email: [email protected] Email: [email protected] Website: www.techgroup.com Website: www.deroyal.com Website: www.tmptech.com Year established: 1973 Year established: 1945 Theken Spine Llc 1800 Triplett Blvd., Akron, OH 44306, United States Tianjin Hanaco Medical Co.,Ltd. Tnc Devices, Inc. Phone: 330-475-8600 7 Dong Ting Street, Econ. & Tech. Devel. Zone 50 Mcdonald Blvd. Email: [email protected] Tianjin, 300061, China Aston, PA 19013, United States Website: www.thekenspine.com Phone: 86-22-988729 Phone: 504-286-7794 Year established: 1998 Timm Medical Technologies, Inc. Togo Medikit Co., Ltd. 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United States Endoscopy Group 7060 Koll Center Parkway, Suite 300 Tyco Healthcare Uk Ltd. 5976 Heisley Road Pleasanton, CA 94566, United States Fareham Rd. Mentor, OH 44060, United States Phone: 925-931-1300 Gosport, Hants, United Kingdom Phone: 440-639-4494 Website: trirememedical.com Phone: 203-845-1000 Fax: 800-769-8226 Year established: 2005 Email: [email protected] TYRX, Inc. Website: www.usendoscopy.com Tri-State Hospital Supply Corp. 1 Deer Park Dr., Suite G Year established: 1991 3173 East 43rd St. Monmouth Junction, NJ 08852, United States Yuma, AZ 85365, United States Phone: 732-246-8676 Univac Dental Company Phone: 517-545-1135 Fax: 866-908-8979 113 Park Drive, PO Box 447 Website: www.tyrx.com Montgomeryville, PA 18936-0447, United States Trivirix International Inc. Year established: 1998 Phone: 215-540-0800 925 6th Avenue NE Fax: 800-523-2559 Milaca, MN 56353, United States Tytex, Inc. 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Usgi Medical Vascomed-Institut Vidacare Corp. 1140 Calle Cordillera Fur Kathetertechnologie Gmbh 4350 Lockhill Selma Rd, Suite 150 San Clemente, CA 92673, United States Hertzallee 1 Shavano Park, TX 78249, United States Phone: 949-369-3890 Binzen, 79589, Germany Phone: 866-479-8500 Email: [email protected] Phone: 49-7621-570900 Fax: 210-375-8537 Website: www.usgimedical.com Email: [email protected] Website: www.vidacare.com Website: www.vascomed.de Year established: 2001 Ussc Puerto Rico, Inc. Year established: 1989 Building 911-67, Sabanetas Industrial Park Vident Ponce, PR 00731, United States Vascular Insights LLC 3150 E. Birch St. Phone: 203-845-1000 395 Boston Post Rd. Brea, CA 92821, United States Website: www.covidien.com Madison, CT 06443, United States Phone: 714-961-6200 Phone: 203-376-3775 Fax: 800-828-3839 Ustomed Instrumente - Website: www.vascularinsights.com Email: [email protected] Ulrich Storz Gmbh & Co. 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Source: MDRWeb.com 251 Whitney Products, Inc. Wright Medical Group, Inc. Zest Anchors, Inc. 6153 Mulford Street, Unit. C 5677 Airline Road 2061 Wineridge Place #100 Niles, IL 60714-3427, United States Arlington, TN 38002, United States Escondido, CA 92029, United States Phone: 847-470-9300 Phone: 901-867-9971 Phone: 760-743-7744 Fax: 847-966-6168 Fax: 800-238-7117 Fax: 800-262-2310 Email: [email protected] Email: [email protected] Email: [email protected] Website: www.whitneyproducts.com Website: www.wmt.com Website: www.zestanchors.com Year established: 1984 Year established: 1950 Year established: 1943

Wilson-Cook Medical, Inc. Wv Iv Pro, Inc. Zevex Incorporated 4900 Bethania Station Rd. 2104 Locust St. 4314 ZEVEX Park Lane Winston Salem, NC 27105, United States Fairmont, WV 26554, United States Salt Lake City, UT 84123-4650, United States Phone: 336-744-0157 Phone: 304-366-6151 Phone: 801-264-1001 Website: www.cookmedical.com Fax: 800-970-2337 Year established: 1963 Wytech Industries, Inc. Email: [email protected] 960 E. Hazelwood Ave. Website: www.zevex.com Wisap America Rahway, NJ 07065-5503, United States Year established: 1986 8231 Melrose Drive Phone: 732-396-3900 Lenexa, KS 66214, United States Email: [email protected] Zimmer Dental, Inc. Phone: 913-492-5888 Website: www.wytech.com 1900 Aston Ave. Fax: 913-492-9142 Year established: 1975 Carlsbad, CA 92008, United States Email: [email protected] Phone: 760-929-4300 Website: www.blueendo.com Xavier Ent. Fax: 800-854-7019 Year established: 1984 Sheikh House , Nasir Rd. Website: www.zimmerdental.com Sialkot, 22161, Pakistan Year established: 1927 Wisap Gesellschaft Fur Phone: 009-243-2594 Wisseusch Apparatebau M.B.H. Zimmer Holdings, Inc. Rudolf Diesel Ring 20 Xiros Plc 1800 W. Center St., PO Box 708 Sauerlach, 82054, Germany 28-30 Blenheim Terrace Warsaw, IN 46581, United States Phone: 8104/890-823 Leeds, United Kingdom Phone: 574-267-6131 Email: [email protected] Phone: 011-324-4694 Fax: 800-613-6131 Website: www.wisap.com Website: www.zimmer.com X-Spine Systems, Inc. Year established: 1927 Witte Gmbh 452 Alexandersville Rd. Mankhauser Str. 1 Miamisburg, OH 45342, United States Zimmer Manufacturing B.V. Solingen, 42699, Germany Phone: 937-847-8400 Route 1, Km. 123.4, Bldg. 1, Turpeaux Industrial Park Phone: 212/331077-78 Fax: 937-847-8410 Mercedita, PR 00715, United States Email: [email protected] Email: [email protected] Phone: 800-613-6131 Website: www.witte-solingen.de Website: www.x-spine.com Website: www.zimmer.com

Wolfgang Atzrodt Xtent, Incorporated Zimmer Orthopaedic Surgical Products Liptinger Str. 32 125 Constitution Dr. P.O. Box 10, 200 West Ohio Ave. Tuttlingen, 78532, Germany Menlo Park, CA 94025, United States Dover, OH 44622, United States Phone: 074--6174911 Phone: 650-475-9400 Phone: 330-343-8801 Email: [email protected] Fax: 800-321-5533 Work ‘N Leisure Products, Inc. Website: www.xtentinc.com Website: www.zimmer.com 455 Fortune Blvd. Year established: 1951 Milford, MA 01757, United States Yama, Inc. Phone: 508-634-0939 650 Liberty Ave. Zimmer Spine Union, NJ 07083, United States 23 West Bacon St. World Heart Inc. Phone: 908-206-8706 North Attleboro, MA 02762, United States 4750 Wiley Post Way, Suite 120 Phone: 508-643-0983 Salt Lake City, UT 84116, United States Yellin Inc. Fax: 508-695-2501 Phone: 801-355-6255 1116 A South St. Website: www.zimmer.com Fax: 888-843-5827 Philadelphia, PA 19147, United States Email: [email protected] Phone: 215-928-8888 Zimmer Spine, Inc. Website: www.worldheart.com 7375 Bush Lake Road Year established: 1969 Yushin Medical Co., Ltd. Minneapolis, MN 55439-2027, United States 6-5, Wonmi-Dong, Wonmi-Gu, Phone: 952-832-5600 World Heart Inc. Bucheon City, Gyeonggi-Do 420-837, Fax: 952-832-5620 7799 Pardee Lane Republic of Korea Website: www.zimmer.com Oakland, CA 94621, United States Phone: 82-32-668-0323 Year established: 1991 Phone: 510-563-5000 Email: [email protected] Fax: 801-355-6255 Website: www.yushinmed.com Zimmer Trabecular Metal Technology Email: [email protected] 10 Pomeroy Road Website: www.worldheart.com Zassi Medical Evolutions, Inc. Parsippany, NJ 07054, United States Year established: 1996 1886 S. 14th St., Suite 6 Phone: 800-613-6131 Fernandina Beach, FL 32034, United States Website: www.zimmer.com World Medical Equipment, Inc. Phone: 904-261-2169 3915 152nd St. NE Email: [email protected] Zinetics Medical, Inc. Marysville, WA 98271, United States Website: www.zassimedical.com 1050 East South Temple Phone: 360-657-7900 Year established: 1997 Salt Lake City, UT 84102, United States Fax: 360-657-7901 Phone: 801-350-8131 Email: [email protected] Zefon International Fax: 801-284-8282 Website: www.worldmedicalequip.com 5350 S.W. First Lane Email: [email protected] Year established: 1992 Ocala, FL 34474, United States Website: www.medtronic.com Phone: 352-854-8080 Year established: 1976 World Precision Instruments (W.P.I.), Inc. Fax: 800-282-0073 175 Sarasota Center Blvd. Email: [email protected] Zoll Medical Corp. Sarasota, FL 34240-9258, United States Website: www.zefon.com 269 Mill Road Phone: 941-371-1003 Year established: 1988 Chelmsford, MA 01824, United States Fax: 866-606-1974 Phone: 978-421-9655 Email: [email protected] Fax: 800-348-9011 Website: www.wpiinc.com Email: [email protected] Year established: 1967 Website: www.zoll.com Year established: 1980 Source: MDRWeb.com 252