FDA medical device companies
7,492 medical device companies with at least 5 cleared 510(k)s or a PMA or De Novo decision. Each page shows clearances per year, median review time against the same product codes, top product codes, the latest clearances and recall counts, from openFDA. Companies are grouped by FDA applicant name; subsidiaries filing under their own name have their own page.
Browse A–Z
A (710) · B (480) · C (611) · D (317) · E (282) · F (148) · G (249) · H (248) · I (379) · J (84) · K (149) · L (225) · M (657) · N (261) · O (257) · P (437) · Q (46) · R (231) · S (821) · T (360) · U (92) · V (174) · W (140) · X (30) · Y (14) · Z (65) · 0-9 (25)
Companies with the most 510(k) clearances
- Abbott Laboratories (889 510(k)s, 30 PMA)
- Siemens Medical Solutions USA, Inc. (784 510(k)s, 3 PMA)
- Boston Scientific Corp (730 510(k)s, 75 PMA, 2 De Novo)
- C.R. Bard, Inc. (655 510(k)s, 5 PMA)
- Bd Becton Dickinson Vacutainer Systems Preanalytic (632 510(k)s, 2 PMA)
- Baxter Healthcare Corp (568 510(k)s, 5 PMA, 1 De Novo)
- Smith & Nephew, Inc. (547 510(k)s, 5 PMA, 1 De Novo)
- Medtronic Vascular (480 510(k)s, 20 PMA)
- Roche Diagnostics Corp. (456 510(k)s, 17 PMA, 3 De Novo)
- Syva Co. (448 510(k)s)
- Biomet, Inc. (445 510(k)s, 1 PMA)
- Zimmer, Inc. (422 510(k)s, 3 PMA)
- Howmedica Corp. (409 510(k)s, 3 PMA)
- Synthes (Usa) (407 510(k)s, 1 PMA)
- Arthrex, Inc. (353 510(k)s)
- Stryker Corp. (352 510(k)s, 2 PMA)
- Dade Behring, Inc. (343 510(k)s, 1 PMA)
- Boehringer Mannheim Corp. (340 510(k)s, 1 PMA)
- KARL STORZ Endoscopy-America, Inc. (334 510(k)s, 3 PMA)
- 3M Company (330 510(k)s, 1 PMA, 2 De Novo)
- GE Medical Systems (329 510(k)s, 1 PMA)
- Cordis Corp. (328 510(k)s, 6 PMA)
- Diagnostic Products Corp. (324 510(k)s)
- Instrumentation Laboratory CO (323 510(k)s, 1 De Novo)
- Bio-Rad (319 510(k)s, 1 PMA)
- Depuy, Inc. (303 510(k)s, 4 PMA)
- Wrightmedicaltechnologyinc (302 510(k)s, 1 PMA)
- Howmedica Osteonics Corp. (301 510(k)s, 2 PMA)
- Roche Diagnostic Systems, Inc. (296 510(k)s)
- Dentsply Intl. (291 510(k)s)
- Em Diagnostic Systems, Inc. (288 510(k)s)
- Helena Laboratories (282 510(k)s)
- Beckman Instruments, Inc. (281 510(k)s)
- Fred Sammons, Inc. (278 510(k)s)
- Beckman Coulter, Inc. (277 510(k)s, 5 PMA, 1 De Novo)
- Medline Industries, Inc. (268 510(k)s, 1 De Novo)
- bioMerieux, Inc. (254 510(k)s, 3 PMA, 1 De Novo)
- General Electric Co. (254 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s, 2 PMA)
- E.I. Dupont DE Nemours & Co., Inc. (253 510(k)s)
- Medtronic, Inc. (247 510(k)s, 42 PMA)
- Hewlett-Packard Co. (246 510(k)s)
- Siemens Healthcare Diagnostics, Inc. (245 510(k)s, 19 PMA, 1 De Novo)
- Eastman Kodak Company (238 510(k)s)
- Sigma Chemical Co. (231 510(k)s)
- Covidien (224 510(k)s, 2 PMA, 1 De Novo)
- STERIS Corporation (223 510(k)s, 4 De Novo)
- Philips Medical Systems, Inc. (218 510(k)s, 4 PMA)
- Aesculap, Inc. (218 510(k)s)
- United States Surgical, A Division of Tyco Healthc (218 510(k)s)
- Argen Precious Metals, Inc. (217 510(k)s)
- Intermedics, Inc. (211 510(k)s)
- DePuy Orthopaedics, Inc. (210 510(k)s, 3 PMA)
- ETHICON, Inc. (208 510(k)s, 5 PMA)
- Johnson & Johnson Professionals, Inc. (206 510(k)s)
- Travenol Laboratories, S.A. (206 510(k)s)
- Varian Medical Systems, Inc. (206 510(k)s)
- Sa Scientific, Inc. (201 510(k)s)
- Intuitive Surgical, Inc. (197 510(k)s)
- Becton, Dickinson & CO (196 510(k)s)
- Sherwood Medical Co. (191 510(k)s)
- Cook, Inc. (190 510(k)s, 5 PMA)
- Olympus Medical Systems Corp. (190 510(k)s)
- Philips Medical Systems (Cleveland), Inc. (190 510(k)s)
- Exactech, Inc. (186 510(k)s, 1 PMA)
- Ethicon Endo-Surgery, Inc. (183 510(k)s, 1 De Novo)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s, 4 PMA)
- Merit Medical Systems, Inc. (181 510(k)s, 1 PMA)
- Osteonics Corp. (178 510(k)s)
- Acumedia Manufacturers, Inc. (177 510(k)s)
- Cook Incorporated (174 510(k)s, 1 PMA, 1 De Novo)
- Globus Medical, Inc. (174 510(k)s, 2 PMA)
- Shiley, Inc. (174 510(k)s)
- Respironics, Inc. (173 510(k)s)
- Ge Medical Systems Information Technologies (171 510(k)s, 1 PMA)
- GE Healthcare (169 510(k)s, 3 PMA)
- Medacta International S.A. (167 510(k)s)
- W. L. Gore & Associates, Inc. (166 510(k)s, 12 PMA)
- Heraeus Kulzer, Inc. (166 510(k)s)
- Nihon Kohden America, Inc. (166 510(k)s)
- Quinton, Inc. (164 510(k)s)
- Sigma Diagnostics, Inc. (164 510(k)s)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160 510(k)s)
- Miles Laboratories, Inc. (158 510(k)s, 1 PMA)
- Terumo Medical Corp. (157 510(k)s, 3 PMA)
- Technicon Instruments Corp. (157 510(k)s)
- Edwards Lifesciences, LLC (156 510(k)s, 18 PMA, 2 De Novo)
- Remel Co. (154 510(k)s)
- Richard Wolf Medical Instruments Corp. (153 510(k)s, 2 PMA)
- Codman & Shurtleff, Inc. (152 510(k)s)
- B.Braun Medical, Inc. (150 510(k)s)
- American Dade (149 510(k)s)
- Arthrocare Corp. (149 510(k)s)
- Olympus Corp. (149 510(k)s)
- Olympus America, Inc. (149 510(k)s)
- Toshiba America Medical Systems, In.C (146 510(k)s)
- Behring Diagnostics, Inc. (145 510(k)s)
- Zeus Scientific, Inc. (142 510(k)s, 3 PMA)
- Edward Weck, Inc. (140 510(k)s)
- Inova Diagnostics, Inc. (136 510(k)s, 2 De Novo)