This publication features the world’s leading medical device and technology companies. This report provides an authoritative and complete overview of the largest manufacturers of medical devices and technologies around the globe in a convenient and concise format. Included are rankings of the largest device and technology companies based on 2009 revenue and a corporate profile of each entity.

Company data featured in this edition include:• Company overview• Financials for recent years• Rankings by revenue• Leadership personnel• Recent acquisitions• Significant subsidiaries• Medical specialties/sectors• Key products

SPECIAL REPORT JUNE 2010

TOP 100 MEdICAL dEvICE COMPANIES

What you Will find in this special report

2 • Top 100 Medical Device Companies

Table of ConTenTs

Notes and methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Top 100 Medical Device Companies by Revenue . . . . . . . . . . . . . . . . . . . .4

Top 100 Medical Device Companies by R&D Spend . . . . . . . . . . . . . . . . . .6

Top 100 Medical Device Companies by Net Income . . . . . . . . . . . . . . . . . .9

Top 100 Medical Device Companies by Earnings Per Share . . . . . . . . . . .11

Top 100 Medical Device Companies by Total Assets . . . . . . . . . . . . . . . . .13

Top 100 Medical Device Companies by Shareholders’ Equity . . . . . . . . .15

Top 100 Medical Device Companies by Employees . . . . . . . . . . . . . . . . . .17

Top 100 Medical Device Company Profiles . . . . . . . . . . . . . . . . . . . . . . . . . .20

oTher Canon proDuCTs

Review the most-recent special reports at: www .PharmaLive .com/SpecialReports see these and other topics: Drug Delivery Review and Outlook; Diabetes Review and Outlook; Account Rosters: Healthcare Communications Agencies; New Drug Review and Outlook; New Medical Device Review and Outlook; CNS/Neurology Review and Outlook; Weight Management Review and Outlook; Biotech/Biopharma/Biosimilar Review and Outlook; M&A, Partnerships and Collaborations Review and Outlook; Top 20 Company Pipelines; Top 15 Therapeutic Areas; Top 100 Medical Device Companies; Top 500 Prescription Medicines; Top 50 Pharma Companies; Top 50 Biotech Companies; Cardiovascular Review and Outlook; and Drugs in Development: Pipeline to Market

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Canon DaTa proDuCTs Group

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Roger BurgVP, OperationsPublications Division

eDITorIal aDvIsors for speCIal reporTs

Jay Carter, SVP Director of Client Services, AbelsonTaylor Inc .sander flaum, President, Flaum PartnersMark havenhand, MBA, Ph .D ., Novartis Pharma AG, Global Head,

Business Strategy & Planning Clinical Medical ServicesJoe Meadows, Vice President, Marketing & Creative Services, Catalina Health Resource boaz Mendzelevski, VP of Cardiology & Chief Medical Officer, Medifacts Internationalsteven Michaelson, Founder/CEO, WISHBONE/ITP Inc .Mike Myers, President, PalioDavid M. oakley, R .Ph ., Ph .D ., Director of Technical Development,

AAI Pharma Deborah schnell, President, Sales and Strategic Planning,

Healthy Advice Networks Marc Weiner, Managing Partner, CommonHealth

Top 100 Medical Device Companies • 3

noTes anD MeThoDoloGy

This second edition of the Top 100 Medical Device Companies report has been produced by the editors of PharmaLive .com

and eKnowledgeBase . The goal with this publication is to provide an authoritative, accurate, and complete overview of the larg-est manufacturers of medical devices and technologies around the world in a convenient and concise format . In this report you will find ranks of the largest 100 medical device and technology companies by revenue, followed by other financial charts and a one-page profile of each entity, in rank order . Each profile includes an overview of the company along with information on execu-tive leadership, recent acquisitions, significant subsidiaries, medical specialties, representative products, and the most recent full fiscal years of financial data .

basis for inclusion: The list of companies herein, as with any such compilation, reflects a number of judgments about the definition of the medical device and technology industry, as well as the availability of information . The companies listed here are primarily public companies, as information about them is readily available . Where possible, the editors have included private companies that provide sufficiently detailed financial data, such as B . Braun Mel-sungen and Biomet . To our knowledge, only one private medical device company that would have qualified for inclusion based on revenue was left out because of insufficient data: the Cook Group out of (Bloomington, Ind .

The editors have included only companies that make finished medical devices or diagnostics sold under their own brands (hence excluding contract manufacturers) . Related categories that were ruled out for the purposes of this ranking include medical services, pharmaceuticals, biotech, biomaterials, device components, medical gases, eye wear, personal care, consumer healthcare products, and nutritional products .

Methodology and sources: In assessing the revenue for the com-panies included in this ranking, the editors counted only revenue from the medical device and technology segments . In cases where a segment included other sources of revenue, we counted the revenue only if medical devices clearly constituted a majority of the revenue . With multi-industry conglomerates, we generally included net income for the entire company, but in some cases, we included operating revenue for the device segments instead .

For companies outside the United States, the revenue and in-come in the profiles are stated both in the original currency and in U .S . dollars . In the ranking, only the dollar figures are included . The currency conversion was performed using the exchange rate on the last day of the period involved, using historical rates obtained from FederalReserve .com .

In the company profiles and main revenue chart, the most re-cent revenue figures are from the latest complete fiscal year as announced by the companies before press time of this publica-tion . In certain instances, estimates were made .

The information used to compile these reports came from a va-riety of sources, including company Websites; annual and quarter-ly reports; public reporting from the SEC, FDA and other regulatory agencies; quarterly earnings calls; the archives of Canon Commu-nications medical device publications; and, in some cases, direct communications with the company itself .

CoMpany profIle ToC paGe

Johnson & Johnson . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Siemens AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21General Electric Co . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Medtronic Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Baxter International Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Koninklijke Philips Electronics NV . . . . . . . . . . . . . . . . . . . . . . . . . . .25Covidien Ltd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Roche Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Cardinal Health Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28Boston Scientific Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29Becton, Dickinson and Co . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Stryker Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 Abbott Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32B . Braun Melsungen AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33Olympus Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34St . Jude Medical Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35 3M Co . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Toshiba Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37Zimmer Holdings Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38Smith & Nephew Plc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Terumo Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Synthes Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41Bayer AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42Beckman Coulter Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43Danaher Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44Alcon Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45Getinge AB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46Fresenius Medical Care AG & Co . KGaA . . . . . . . . . .47 Carestream Health Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48C .R . Bard Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49Biomet Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50Varian Medical Systems Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51Paul Hartmann AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52Dentsply International Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53Kinetic Concepts Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54Inverness Medical Innovations Inc . . . . . . . . . . . . . . . . . . . . .55 Teleflex Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56Drägerwerk AG & Co . KGaA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57Coloplast A/S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58BioMérieux SA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59Invacare Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Agfa-Gevaert NV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61Hologic Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62Sonova Holding AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63 Hill-Rom Holdings Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64Kimberly-Clark Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65Smiths Group Plc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Edwards Lifesciences Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67Sysmex Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68Nipro Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Hitachi Medical Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70Nihon Kohden Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71Konica Minolta Holdings Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72Hospira Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73Cooper Companies Inc ., The . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74William Demant Holding A/S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75Intuitive Surgical Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76Fukuda Denshi Co . Ltd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77Sorin SpA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Carl Zeiss Meditec AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79Steris Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80ResMed Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Elekta AB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82Nobel Biocare Holding AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83Allergan Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84Sirona Dental Systems Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85Omron Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86Conmed Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87Integra LifeSciences Holdings Corp . . . . . . . . . . . . . . . . . . . .88Straumann Holding AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89Haemonetics Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90Mindray Medical International Ltd . . . . . . . . . . . . . . . . . . . 91Cochlear Ltd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92GN Store Nord A/S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Orthofix International NV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94Greatbatch Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95American Medical Systems Holdings Inc . . . . . . . . . .96Gen-Probe Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97Wright Medical Group Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98ev3 Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Nikkiso Co . Ltd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100Analogic Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101 Zoll Medical Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102Thoratec Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103NuVasive Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104Masimo Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105Topcon Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106Symmetry Medical Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107Ansell Ltd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108ArthroCare Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109Align Technology Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110Immucor Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Medical Action Industries Inc . . . . . . . . . . . . . . . . . . . . . . . . . . 112Cantel Medical Corp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113Merit Medical Systems Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .114Horiba Ltd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115Accuray Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .116ICU Medical Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117SonoSite Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118OSI Systems Inc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

10 • Top 100 Medical Device Companies

Top 100 Medical Device Companies — net Income

Company name fiscal year end 2009 net Income 2008 net Income

Immucor Inc . (NasdaqGS: BLUD) 2009 = May 2009; 2008 = May 2008 $76,183,000 $71,454,000

Integra LifeSciences Holdings Corp . (NasdaqGS: IART) December 50,955,000 27,727,000

Intuitive Surgical Inc . (NasdaqGS: ISRG) December 232,606,000 204,315,000

Invacare Corp . (NYSE: IVC) December 41,179,000 34,857,000

Inverness Medical Innovations Inc . (AMEX: IMA) December 10,744,000 (35,757,000)

Johnson & Johnson (NYSE: JNJ) December 12,266,000,000 12,949,000,000

Kimberly-Clark Corp . (NYSE: KMB) December 1,994,000,000 1,690,000,000

Kinetic Concepts Inc . (NYSE: KCI) December 228,702,000 166,444,000

Konica Minolta Holdings Inc . (TSE: 4902) 2009 = March 2010; 2008 = March 2009 186,637,212 167,324,213

Koninklijke Philips Electronics NV (ENXTAM: PHIA) (NYSE: PHG) December 590,844,000 (128,202,000)

Masimo Corp . (NasdaqGS: MASI) December 53,228,000 31,927,000

Medical Action Industries Inc . (NasdaqGS: MDCI) 2009 = March 2010; 2008 = March 2009 16,841,000 4,955,000

Medtronic Inc . (NYSE: MDT) 2009 = April 2010; 2008 = April 2009 3,099,000,000 2,070,000,000

Merit Medical Systems Inc . (NasdaqGS: MMSI) December 22,530,000 20,727,000

Mindray Medical International Ltd . (NYSE: MR) December 139,188,000 108,687,000

Nihon Kohden Corp . (TSE: 6849) 2009 = March 2010; 2008 = March 2009 65,225,467 50,817,881

Nikkiso Co . Ltd . (TSE: 6376) 2009 = March 2009; 2008 = March 2008 15,080,013 40,312,580

Nipro Corp . (TSE: 8086) 2009 = March 2010; 2008 = March 2009 79,941,708 49,936,009

Nobel Biocare Holding AG (VIRTX: NOBN) December 147,481,073 152,809,817

NuVasive Inc . (NasdaqGS: NUVA) December 5,808,000 (27,528,000)

Olympus Corp . (TSE: 7733) (OTCPK: OCPNY .PK) 2009 = March 2010; 2008 = March 2009 526,510,730 (1,265,596,735)

Omron Corp . (OSE: 6645) 2009 = March 2010; 2008 = March 2009 38,780,327 (321,574,671)

Orthofix International NV (NasdaqGS: OFIX) December 24,472,000 (228,554,000)

OSI Systems (NasdaqGM: OSIS) 2009 = June 2009; 2008 = June 2008 11,152,000 13,860,000

Paul Hartmann AG (DB: PHH2) December 81,606,147 35,832,459

ResMed Inc . (NYSE: RMD) 2009 = June 2009; 2008 = June 2008 110,303,000 66,302,000

Roche Diagnostics December 7,836,095,764 (for Roche group) 9,985,267,035 (for Roche group)

Siemens AG (DB: SIE) (NYSE: SI) 2009 = Sept . 2009; 2008 = Sept . 2008 3,340,590,000 8,344,187,500

Sirona Dental Systems Inc . (NasdaqGS: SIRO) 2009 = Sept . 2009; 2008 = Sept . 2008 53,355,000 29,439,000

Smith & Nephew Plc . (LSE: SN) December 472,000,000 377,000,000

Smiths Group Plc . (LSE: SMIN) 2009 = July 2009; 2008 = July 2008 442,206,000 440,240,640

SonoSite Inc . (NasdaqGS: SONO) December 3,283,000 11,222,000

Sonova Holding AG (SWX: SOON) 2009 = March 2010; 2008 = March 2009 332,657,979 266,369,773

Sorin SpA (CM: SRN) December 32,329,200 (51,698,850)

St . Jude Medical Inc . (NYSE: STJ) December 777,226,000 353,018,000

Steris Corp . (NYSE: STE) 2009 = March 2010; 2008 = March 2009 128,467,000 110,685,000

Straumann Holding AG (SWX: STMN) December 134,806,630 7,550,645

Stryker Corp . (NYSE: SYK) December 1,107,400,000 1,147,800,000

Symmetry Medical Inc . (NYSE: SMA) December 21,784,000 24,019,000

Synthes Inc . (VIRTX: SYST) December 823,955,000 734,964,000

Sysmex Corp . (TSE: 6869) 2009 = March 2010; 2008 = March 2009 107,632,493 88,341,540

Teleflex Inc . (NYSE: TFX) December 302,994,000 119,774,000

Terumo Corp . (TSE: 4543) 2009 = March 2010; 2008 = March 2009 448,883,936 406,521,003

Thoratec Corp . (NasdaqGS: THOR) December 28,584,000 18,331,000

Topcon Corp . (TSE: 7732) 2009 = March 2010; 2008 = March 2009 1,466,112 (110,145,829)

Toshiba Corp . (TSE: 6502) 2009 = March 2010; 2008 = March 2009 (217,161,011) (3,787,640,783)

Varian Medical Systems Inc . (NYSE: VAR) 2009 = Sept . 2009; 2008 = Sept . 2008 319,022,000 279,484,000

William Demant Holding A/S (CPSE: WDH) December 148,374,211 127,375,219

Top 100 Medical Device Companies • 29

Top 100 Rank: 10

Boston Scientific Corp .One Boston Scientific PlaceNatick, MA | 01760United States

Phone: 508-650-8000Fax: 508-650-8923www .bostonscientific .com

Boston Scientific is a global developer, manufacturer and marketer of medical devices . The company’s

products are used in a wide range of interventional medical specialties . The company grew out of

the 1979 purchase of Medi-Tech Inc . by John Abele and Pete Nicholas . Mr . Abele had acquired an equity

interest in Medi-Tech in 1969 and through the company brought to market a steerable catheter, invented

by Itzak Bentov, used for less-invasive surgeries . The combined company concentrated on catheters and

other alternatives to traditional surgery . The product line soon expanded to include devices for cardiac,

vascular, respiratory, gastrointestinal, and urological procedures . The firm grew throughout the 1980s, and

sold 20% of itself to Abbott Laboratories to raise needed capital . Sales in 1991 reached $230 million, and in

1992 the company went public . The IPO brought in $400 million and the return of Abbott’s stake . Starting in

late 1994, Boston Scientific went on a 16-month buying spree, acquiring nine companies for a total of nearly

$2 .4 billion . Revenue in 1995 amounted to $1 .2 billion, and the company’s market cap reached $8 .5 billion

by year-end .

By late 1996, Boston Scientific had direct sales forces in 17 countries and distribution deals in 85 others .

Further acquisitions through the end of the 1990s gave the company leading positions in the neurosurgery

and cardiovascular stent markets, but the strains of integrating and managing these far-flung enterprises, a

major recall, and the continual struggle to stay abreast of competitors began to take their toll . For 1998, the

company reported a loss of $264 million on revenue of $2 .23 billion .

The past decade has seen Boston Scientific continue this pattern of acquisition and organic growth,

punctuated by occasional recalls and other speed bumps . The 2006 merger with Guidant, viewed by some

to be overpriced, resulted in a $3 .5+ billion loss in that year, but added cardiac rhythm management to the

company’s portfolio . During first-quarter 2008, various non-core businesses were sold, helping to streamline

operations and resulting in proceeds of nearly $1 .3 billion . During fourth-quarter 2008, FDA approved several

significant new products for Boston Scientific, several favorable studies involving the company’s products

were released, and clinical studies for next-generation stents took place .

For the first quarter of calendar-year 2010, Boston Scientific generated sales of $1 .96 billion and adjusted

EPS of 16 cents . A GAAP loss of $1 .05 per share was reported . The company maintained a leadership posi-

tion in the worldwide drug-eluting stent (DES) market with a 45% share in America, 43% share in Japan, and

38% global share .

FINANCIALS

NYSE: BSX

Fiscal Year Revenue ($ millions)Net Income/(Loss)

($ millions)

2009 8,188 (1,025)

2008 8,050 (2,036)

2007 8,357 (495)

2006 7,821 (3,577)

2005 6,283 628

2004 5,624 1,062

Fiscal year ends Dec. 31.

Medical specialties• Cardiovascular,neurovascular,and

peripheral vascular diseases and disorders• Cardiacrhythmmanagement• Gastroenterology• Neuromodulation

Key products• Taxus,Liberté,andExpresscoronarystents• Cogniscardiacresynchronizationtherapy

defibrillator• Confient,Teligen,andVitalityimplantable

cardioverter defibrillators• ExplorerandInquirydiagnosticcardiology

catheters• iLabultrasoundimagingsystem;Atlantis

SR Pro ultrasound imaging catheter• Polyflex,UltraflexandWallflexesophageal,

duodenal, and colonic stents• Sterlingballoondilationcatheters• VersaPulsePowerSuiteholmiumurology

laser systems

significant subsidiaries• AdvancedStentTechnologiesInc.• BostonScientificNeuromodulationCorp.• CardiacPacemakersInc.• CatheterInnovationsInc.• CorvitaCorp.• EndoVascularTechnologiesInc.• EntericMedicalTechnologiesInc.• GuidantCorp.• IntermedicsInc.• InterventionalTechnologiesLLC• PrecisionVascularSystemsInc.

leadershipJ. raymond elliott, President, and CEO

brian r. burns, Senior VP, Global Quality

Jeffrey D. Capello, Executive VP and CFO

fredericus a. Colen, Executive VP and

Chief Technology Officer

Jean fitterer lance, Senior VP and Chief

Compliance Officer

RECENt ACqUISItIONS

Date of Acquisition Company Price ($ millions)

January 2009 Labcoat Ltd . (Ireland) N/A

August 2007 Remon Medical Technologies Inc . 73

January 2007 EndoTex Interventional Systems Inc . 140

April 2006 Guidant Corp . 27,000

June 2005 Rubicon Medical Corp . 90

April 2005 CryoVascular Systems Inc . 60

April 2005 TriVascular 110

March 2005 Advanced Stent Technologies Inc . 120

June 2004 Advanced Bionics Corp . 740

April 2004 Precision Vascular Systems Inc . 75

boston scientific Corp.

Popular trends in medical device innovation include combination devices of drugs and biologics, nanotechnology, use of less-invasive surgeries and devices, and IT/wireless technology for hospitals. In the next few years, neurology, cardiovascular and orthopedics represent promising technological opportunities due to an aging population. Industry segments such as oncology and cardiology will remain more immune to market dynamics and changes.

Many medical device companies expect that healthcare legislation could have a negative impact on the industry during 2010. The largest challenge will be an increase in FDA regulations for oversight as well as compliance. However, this legislation will not stop the industry from generating solid revenue growth.

The United States remains the market leader for medical devices due in part to the country’s R&D costs, which are nearly double the expenditures for each of Japan and the European Union. China has been projected to overtake Japan as the No. 2 country for medical devices during the second half of this decade. Demand for medical devices and services is projected to continue growing in emerging markets due to their improving economies, rapidly increasing and aging populations, as well as prevalence of chronic disease. Other surging markets in addition to China include India as well as countries located in Central and Eastern Europe.

SPECIAL REPORT MARCH 2010

NEw MEdICAL dEvICE REvIEw ANd OuTLOOk

INduSTRy gROwTH wILL bE SuSTAINEd by CONTINuEd LAuNCHES Of INNOvATIvE PROduCTS

2

Table of conTenTsIntroduction to New Medical Device Review and Outlook . . . . . . . . . . . . . . . . . . . 3

The Year in Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

A Look Ahead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Poised for Growth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

A Review of the New Medical Devices of 2009 and 2010 . . . . . . . . . . . . . . . . . . . . 6

Attracting Investors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

FDA Fallout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Patent Push in 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Safety Comes First . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Lowering a Levy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Other World Markets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Premarket Approvals (PMA) by FDA During 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Premarket Approvals (PMA) by FDA During 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

510(k) Premarket Notification Approvals by FDA During 2009 . . . . . . . . . . . . . . . . 45

oTher canon producTs

Review the most recent special reports at: www .PharmaLive .com/SpecialReports see these and other topics: CNS/Neurology Review and Outlook; Weight Management Review and Outlook; Biotech/Biopharma/Biosimilar Review and Outlook; M&A, Partnerships and Collaborations Review and Outlook; Top 20 Company Pipelines; Top 15 Therapeutic Areas; Top 100 Medical Device Companies; Top 500 Prescription Medicines; Top 50 Pharmaceutical Companies; Top 50 Biotech Companies; Cardiovascular Review and Outlook; and Drugs in Development: Pipeline to Market

eKnowledgebase - searchable pipeline and business-information database for the world’s pharma & biotech companies . request a trial at: www .PharmaLive .com/newEKB

MdrWeb.com - searchable database of global medical device companies and their products . learn more at: www .MDRWeb .com - enter promo code srTrIal for free two-week trial access .

For more information on these products contact: Sandra .Baker@cancom .com or call: 215-944-9836

canon daTa producTs Group

Canon IMM Inc.828 Newtown-Yardley RoadSuite ANewtown, PA 18940Phone: 215 .944 .9800Fax: 215 .867 .0053 Website: PharmaLive .com

Glenn GlasbergCirculation and Marketing Director glenn .glasberg@cancom .com215 .944 .9810

Sandra Baker Data Products Manager sandra .baker@cancom .com215 .944 .9836

Jennifer Schlegel Assistant Marketing Manager jennifer .schlegel@cancom .com215 .944 .9821

Andrew Humphreys Editor In Chief, Data Products andrew .humphreys@cancom .com215 .944 .9812

Stefanie Fedder Data Integrity Managerstefanie .fedder@cancom .com215 .944 .9807

Silvia Arriola Data Specialistsilvia .arriola@cancom .com215 .944 .9803

Kim Stannard Data Specialistkimberly .stannard@cancom .com215 .944 .9826

Diane StrohmData Specialist diane .strohm@cancom .com215 .944 .9828

corporate headquartersCanon Communications LLC11444 W . Olympic Blvd . Los Angeles, CA 90064 Phone: 310 .445 .4200 Fax: 310 .445 .4299 Website: Canon .com

Ron WallSenior VP, Publications

Roger BurgVP, OperationsPublications Division

edITorIal advIsors for specIal reporTs

Jay carter, SVP Director of Client Services, AbelsonTaylor Inc .sander flaum, President, Flaum PartnersMark havenhand, MBA, Ph .D ., Novartis Pharma AG, Global Head,

Business Strategy & Planning Clinical Medical ServicesJoe Meadows, Vice President, Marketing & Creative Services, Catalina Health Resource boaz Mendzelevski, M .D ., VP of Cardiology & Chief Medical Officer, Medifacts Internationalsteven Michaelson, Founder/CEO, Wishbone/ITP Inc .Mike Myers, President, Paliodavid M. oakley, R .Ph ., Ph .D ., Director of Technical Development,

AAI Pharma deborah schnell, President, Sales and Strategic Planning,

Healthy Advice Networks Marc Weiner, Managing Partner, CommonHealth

3

Similar to many other industries, the medi-cal device arena is experiencing an eco-nomic upswing after a turbulent 2008 and 2009 due to the worldwide economic re-cession . More than half of the industry’s players expect to generate stronger 2010 financials compared with their economic performances of 2009 . As for funding, the medical device industry produced a dou-ble-digit increase as of year-end 2009 ver-sus the previous calendar term .

Financial analysts anticipate that the medical device industry will generate a compound annual growth rate ap-proaching 10% for the next few years . In the meantime, the strength of this indus-try is being tested by a changing regula-tory landscape, investment and funding cutbacks, as well as intellectual-property challenges as the new decade kicked off . The regulatory and legislative hurdles that the industry is facing are more important

than ever as all parties work to ensure that patients continue to have timely access to safe, affordable and effective medi-cal technologies .

The pace of innovation and develop-ment in the medical device industry ac-celerated in 2009 as scientific and tech-nological breakthroughs converged . The industry is in dire need of cost-cutting so-lutions and better clinical outcomes with less-invasive procedures and shorter re-covery times .

Several factors are predicted to influ-ence the growth rate of the medical de-vice industry: an aging population, shifting disease patterns, a shortage of health-care professionals, and the merging of IT with medical devices and technologies . Whether these factors will stifle innovation or spur success remains to be seen .

The global market value for minimally invasive medical devices is predicted to grow from $14 .8 billion in 2008 to $23 billion in 2014 . Challenges to the medical device industry in 2010 and beyond include the effects of healthcare reform and the pro-posed innovation tax, as well as maintain-ing quality while reducing costs .

When compared with investments in pharmaceutical and biotechnology companies, the medical device sector exhibits higher profitability and IPO returns with fewer barriers to entry . Despite be-ing pressured to lower costs on high-tech products and the uncertainty about fu-ture reimbursement policies, medical de-vice companies continue to develop new devices and upgrades that allow price in-creases and large profit margins . Further, medical device companies are predict-ed to grow in emerging markets that in-clude China and India .

Analysts with Zacks Investment Re-search identify the potential for growth among companies producing cardio-vascular devices and surgical equip-ment, blood-related products, and asso-ciated consumables . The analysts favor Medtronic Inc ., baxter International Inc ., haemonetics Corp ., and Intuitive sur-gical Inc . These are all producers of life-sustaining products that are compara-tively less affected by the current state of the economy . Among these compa-nies, Medtronic has a diversified presence in cardiovascular, neurologic, spinal, dia-betes, and ENT .

Zacks Investment’s industry outlook also includes companies that have long-term potential such as boston scientific Corp ., a leader in the cardiology field; st. Jude Medical Inc . for neurological devic-es, and becton, dickinson and Co . for its disposable products . The analysts are somewhat cautious of these companies based on poor stock performances in re-cent quarters and will continue to closely monitor their results .

Zacks Investment analysts have iden-tified weaknesses in the orthopedic mar-ket primarily due to the increasing trend of patients deferring elective procedures because of the economy . The trend has affected conmed Corp . With the econo-my demonstrating signs of recovery, a few companies are beginning to turn around their performances after being affected by this trend . These include symmetry Medical Inc ., Wright Medical Group Inc ., and hanger orthopedic Group Inc .

The healthcare delivery system is poised for fundamental changes that will revolutionize the way in which treatments are administered . This potential can only be realized if the industry overcomes the

neW MedIcal devIce revIeW and ouTlooK

Top MedIcal devIce ManufacTurers (July/august 2009)

(Medical product outsourcing)

1 . Johnson & Johnson $23 .1 Billion2 . GE $17 .4 Billion3 . Siemens $16 .1 Billion4 . Cardinal Health $13 .7 Billion5 . Medtronic $13 .5 Billion6 . Baxter International $12 .3 Billion7 . Philips Healthcare $10 .7 Billion8 . Covidien $8 .9 Billion9 . Boston Scientific $8 Billion10 . Abbott Laboratories $7 .2 Billion11 . Becton Dickinson $7 .2 Billion12 . Stryker $6 .7 Billion13 . B . Braun $5 .3 Billion14 . St . Jude Medical $4 .3 Billion15 . 3M Healthcare $4 .2 Billion16 . Zimmer $4 .1 Billion17 . Toshiba $3 .9 Billion18 . Smith & Nephew $3 .8 Billion19 . Hospira $3 .6 Billion20 . Danaher $3 .3 Billion20 . Olympus Medical Systems $3 .3 Billion22 . Synthes $3 .2 Billion23 . Beckman Coulter $3 .1 Billion24 . Terumo $3 Billion25 . Alcon $2 .9 Billion26 . Fresenius Medical $2 .8 Billion27 . Biomet $2 .4 Billion27 . CR Bard $2 .4 Billion29 . Dentsply International $2 .2 Billion30 . Agfa Healthcare $1 .7 Billion

Source: University of Michigan-Flint

WhaT Is a MedIcal devIce?

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article including a component part, or accessory that is:• recognized in the official

National Formulary, or the U .S . Pharmacopoeia, or any supplement to them,

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• intended to affect the structure or any function of the body of man or other animals, and that does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and that is not dependent upon being metabolized for the achievement of any of its primary intended purposes .

Source: University of Michigan-Flint

38

Medical devices approved by fda in 2009 via premarket approval (pMa)

* Only devices that have gone through FDA’s Premarket Approval process and were approved during 2009 are listed. Source: FDA

REPEL-CV Bioresorbable Adhesion Barrier - P0700058 • Category: Adhesion Barrier • Date: 3/6/09product name: REPEL-CV Bioresorbable Adhesion Barrier pMa applicant: SyntheMed Inc . address: 200 Middlesex-Essex Turnpike Suite 210, Iselin, NJ 08830 approval date: March 6, 2009 approval letter: http://www .accessdata .fda .gov/cdrh_docs/pdf7/P070005a .pdfWhat is it? REPEL-CV Bioresorbable Adhesion Barrier is a single-use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG) . PLA and PEG are used in other types of resorbable medical devices such as bone screws and sutures . This film is designed to provide a temporary barrier within the chest cavity that prevents adhesions from forming .how does it work? REPEL-CV prevents interconnection (adhesions) between two opposing surfaces, specifically between the chest wall and the pericardium (a membrane that covers the heart) . As the body tries to heal after cardiac surgery, the natural response is to increase the number of fibroblasts at the injury site . Fibroblasts are cells that can turn into dense adhesions that surgeons have difficulty navigating through when a patient has to have a repeat surgery . The REPEL-CV interrupts this process of adhesion formation and reduces the severity of the adhesions .When is it used? REPEL-CV is indicated for reducing the severity of post-operative cardiac adhesions in pediatric patients who are likely to require reoperation via sternotomy .What will it accomplish? REPEL-CV was shown to be effective in reducing the severity of post-operative cardiac adhesions . In the clinical study, 21% of the investigational surgical site for all patients consisted of severe adhesions in the group that received the REPEL-CV compared to 47% of the investigational surgical site for all patients in the group that did not receive the REPEL-CV . Mediastinitis was one of the adverse events observed in the treated patients .When should it not be used? There are no known contraindications for this device .

ARCHITECT® CORE Reagent Kit, Calibrator and Controls - P0800239 • Category: HBV Test • Date: 4/10/09product name: ARCHITECT® CORE Reagent Kit, ARCHITECT® CORE Calibrator, ARCHITECT® CORE Controls pMa applicant: Abbott Laboratories address: Abbott Laboratories, Abbott Diagnostics Division, 100 and 200 Abbott Park Road, Abbott Park, IL 60064-3500 approval date: April 10, 2009 approval letter: http://www .accessdata .fda .gov/cdrh_docs/pdf8/P080023a .pdfWhat is it? The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen . Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV . The presence of the anti-HBc antibodies can help determine if a person is currently infected or has previously been infected with HBV . This test is designed for use on the ARCHITECT i Systems (i 2000 and i2000 SR) .how does it work?

The ARCHITECT ® CORE Reagent Kit is a chemiluminescent microparticle immunoassay •A sample of a person’s blood is combined with recombinant HBc Antigen (rHBcAg) coated paramagnetic microparticles •If anti-HBc antibodies are present in the blood, they bind to the rHBcAg coated microparticles •A labeled anti-human conjugate is added, producing a chemiluminescent reaction with the antibodies bound to the •microparticles The amount of light produced can be measured by the system . •The presence or absence of anti-HBc in the patient’s blood is determined by comparison to an active calibration . •

When is it used? This lab test is used to determine if the person is, or has been, infected with HBV .What will it accomplish? Results of this lab test, in combination with other clinical results, may help a doctor determine:

The stage of HBV infection •An appropriate course of treatment, when used in conjunction with other laboratory tests indicating infection with the hepatitis B virus •

When should it not be used? This lab test should not be used if it has not been ordered by a physician . This test is a prescription device . This test has not been FDA licensed for screening blood, plasma, tissue donors, or immunocompromised or immunosuppressed patients . There are no other known patient exclusions .

Medtronic® Attain Ability™ Model 4196 Lead - P08000610 • Category: Pacemaker Leads • Date: 4/7/09product name: Medtronic® Attain Ability™ Model 4196 Lead pMa applicant: Medtronic Inc . address: 8200 Coral Sea St . NE, Mounds View, MN 55112 approval date: April 7, 2009 approval letter: http://www .accessdata .fda .gov/cdrh_docs/pdf8/P080006a .pdfWhat is it? The Medtronic® Attain Ability™ Model 4196 Lead (Model 4196) is a surgically implanted insulated wire that is designed to be used as part of a biventricular pacemaker system . The Model 4196 lead is designed to be implanted in a branch of the coronary vein that goes over the surface of the heart’s left ventricle . A small amount of steroid (dexamethasone acetate) at the tip is intended to reduce inflammation of the surrounding tissue . The other end of the lead connects to an implanted biventricular pacemaker or

45Sources: eKnowledgeBase (eknowledgebase.com) and MDR Web (MDRWeb.com)

Medical devices approved by fda in 2009 via 510(k) Premarket Notification

decision date device name FDA 510K device classification name registration number applicant

1/15/2009 Levitronix, Thoratec Centrimag Back-Up Consoles

K090004 Controller, Pump Speed, Cardiopulmonary Bypass

870 .438 Levitronix LLC .

1/22/2009 Patlog, Patlog Patient Handling System, Patlog Toplog Table Top, Model(S) 1 .0, 1 .0, C

K090044 Accelerator, Linear, Medical 892 .505 Oncolog Medical Qa Ab

1/23/2009 Airstrip Ob K090061 Monitor, Perinatal 884 .274 Airstrip Technologies, Lp

1/28/2009 Thd Slide One K090009 Monitor, Ultrasonic, Non-Fetal 892 .154 Thd Spa

1/28/2009 Color Lcd Monitor, Radiforce Rx320 K090045 Image Processing System 892 .205 Eizo Nanao Corporation

1/30/2009 Retcam Portable Ophthalmic Imaging System, Model Rcp

K083771 Camera, Ophthalmic, AC-Powered (Fundus)

886 .112 Clarity Medical Systems

1/30/2009 If Series True Sine Interferential Stimulator, Model: Wl-2206B And Wl-2106E

K090023 Unit, Therapy, Current, Interferential

Well-Life Healthcare Limited

1/30/2009 All-In-One Container K090096 Container, IV 880 .503 Baxter Healthcare Corporation

1/30/2009 Maxim Hygiene Organically Grown Cotton Tampon

K090098 Tampon, Menstrual, Unscented

884 .547 Maxim Hygiene Products, Inc .

2/1/2009 Olecranail Intramedullary Fixation System

K090091 Rod, Fixation, Intramedullary 888 .302 Mylad Orthopedic Solutions LLC

2/2/2009 Modification To: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

K083711 Electrosurgical Unit, Cutting & Coagulation Device

878 .44 Barrx Medical, Incorporated

2/2/2009 Blood Pressure Monitor, Zsbp-003/004/005/006/007/008 And Zsbp-102/103/104/105/106/107

K090027 Monitor, Blood Pressure, Indirect, Semi-Automatic

870 .113 Zen Strong Medical Technology Co ., Ltd

2/4/2009 Spyscope Access And Delivery Catheter

K090170 Mini Endoscope, Gastroenterology-urology

876 .15 Boston Scientific Corp .

2/5/2009 Sicat Implant K090119 Image Processing System 892 .205 Sicat GmbH & Co . Kg

2/5/2009 Nuovoguard K090122 Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

880 .52 U .S . Safety Syringes Co ., Inc .

2/5/2009 Neuviz 16 Multi-Slice Ct Scanner System

K090173 Scanner, Computed Tomography, X-Ray, Special Procedure

892 .175 Neusoft Medical Systems Co ., Ltd .

2/6/2009 Radifocus Glidecath (Or Radifocus Glidecath Xp)

K090040 Catheter, Intravascular, Diagnostic

870 .12 Terumo Medical Corp .

2/6/2009 Aplio Artida V2 .0 Ssh-880Cv K090158 Scanner, Ultrasonic (Pulsed Doppler)

892 .155 Toshiba America Medical Systems, Inc .

2/6/2009 Insorb Absorbable Staple, Model 1020, 1025, And Other Product Families

K090159 Staple, Implantable 878 .475 Incisive Surgical, Inc .

2/10/2009 Halo Ablation Catheter K083737 Electrosurgical Unit, Cutting & Coagulation Device

878 .44 Barrx Medical, Incorporated

2/10/2009 Equistream Long-Term Hemodialysis Catheters

K090101 Catheter, Hemodialysis, Implanted

876 .554 C .R . Bard, Inc .

2/10/2009 Blood Tubing Sets (Sterile Fluid Path) K090255 Kit, Tubing, Blood, Anti-Regurgitation

876 .582 Nxstage Medical, Inc .

2/11/2009 100Kgy E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom And +3 Hi-Wall

K090103 Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish

888 .335 Biomet, Inc .

2/11/2009 Waterlase Md K090181 Laser, Surgical 878 .481 Biolase Technology, Inc .

2/11/2009 Colon View, Model Cscv-001A K090220 Scanner, Computed Tomography, X-Ray, Special Procedure

892 .175 Toshiba Medical Systems Corporation

2/12/2009 Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113

K090085 Catheter, Thrombus Retriever 870 .125 Concentric Medical, Inc .