FDA device companies by parent company

FDA records 510(k), PMA and De Novo filings under the applicant name on each submission, so one company often appears under many names: divisions, subsidiaries and businesses it acquired. These pages add those names up for each parent company. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

• Siemens Healthineers (3,732 510(k)s, 33 PMA, 2 De Novo; 65 applicant names)
• Medtronic (2,727 510(k)s, 104 PMA, 5 De Novo; 117 applicant names)
• Stryker (2,551 510(k)s, 16 PMA, 3 De Novo; 68 applicant names)
• Johnson & Johnson MedTech (2,309 510(k)s, 56 PMA, 3 De Novo; 78 applicant names)
• BD (Becton, Dickinson and Company) (1,959 510(k)s, 16 PMA; 49 applicant names)
• GE HealthCare (1,905 510(k)s, 7 PMA, 2 De Novo; 89 applicant names)
• Philips (1,756 510(k)s, 13 PMA, 2 De Novo; 86 applicant names)
• Abbott (1,717 510(k)s, 119 PMA, 5 De Novo; 68 applicant names)
• Zimmer Biomet (1,374 510(k)s, 6 PMA; 30 applicant names)
• Boston Scientific (1,355 510(k)s, 85 PMA, 3 De Novo; 42 applicant names)
• Roche Diagnostics (1,334 510(k)s, 53 PMA, 9 De Novo; 24 applicant names)
• Smith+Nephew (1,167 510(k)s, 6 PMA, 1 De Novo; 21 applicant names)
• Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid) (1,096 510(k)s, 6 PMA, 4 De Novo; 36 applicant names)
• Thermo Fisher Scientific (930 510(k)s, 4 PMA, 4 De Novo; 30 applicant names)
• Baxter (821 510(k)s, 5 PMA, 1 De Novo; 23 applicant names)
• Olympus (744 510(k)s, 2 PMA; 25 applicant names)
• B. Braun (597 510(k)s, 1 PMA; 23 applicant names)
• Solventum (formerly 3M Health Care) (589 510(k)s, 1 PMA, 3 De Novo; 26 applicant names)
• Teleflex (566 510(k)s, 2 PMA, 2 De Novo; 29 applicant names)
• Fujifilm Healthcare (565 510(k)s, 2 PMA; 24 applicant names)
• Terumo (562 510(k)s, 12 PMA; 25 applicant names)
• Dentsply Sirona (541 510(k)s, 1 PMA; 14 applicant names)
• Cook Medical (531 510(k)s, 10 PMA, 3 De Novo; 16 applicant names)
• Werfen (523 510(k)s, 3 De Novo; 8 applicant names)
• QuidelOrtho (494 510(k)s, 9 PMA, 5 De Novo; 10 applicant names)
• Integra LifeSciences (460 510(k)s, 7 PMA; 22 applicant names)
• Bio-Rad Laboratories (458 510(k)s, 5 PMA, 1 De Novo; 5 applicant names)
• KARL STORZ (456 510(k)s, 3 PMA; 11 applicant names)
• STERIS (450 510(k)s, 4 De Novo; 16 applicant names)
• Envista (Nobel Biocare, Ormco, Kerr) (437 510(k)s; 17 applicant names)
• Canon Medical Systems (435 510(k)s; 9 applicant names)
• Globus Medical (423 510(k)s, 3 PMA; 7 applicant names)
• CONMED (420 510(k)s, 1 PMA; 16 applicant names)
• Enovis (DJO) (407 510(k)s, 3 PMA; 17 applicant names)
• bioMérieux (402 510(k)s, 4 PMA, 7 De Novo; 9 applicant names)
• ICU Medical (316 510(k)s, 1 PMA; 16 applicant names)
• Edwards Lifesciences (282 510(k)s, 18 PMA, 2 De Novo; 8 applicant names)
• Hologic (281 510(k)s, 24 PMA, 3 De Novo; 23 applicant names)
• Bausch + Lomb (277 510(k)s, 33 PMA; 8 applicant names)
• Getinge (260 510(k)s, 2 PMA; 21 applicant names)
• CooperCompanies (236 510(k)s, 12 PMA; 13 applicant names)
• Cardinal Health (230 510(k)s; 15 applicant names)
• Straumann Group (227 510(k)s; 13 applicant names)
• Intuitive Surgical (224 510(k)s; 3 applicant names)
• LivaNova (217 510(k)s, 4 PMA; 14 applicant names)
• Elekta (204 510(k)s; 17 applicant names)
• Fresenius Medical Care (201 510(k)s; 11 applicant names)
• Drägerwerk (195 510(k)s; 15 applicant names)
• Alcon (194 510(k)s, 53 PMA; 15 applicant names)
• Mindray (168 510(k)s; 4 applicant names)
• Convatec (149 510(k)s; 10 applicant names)
• ZEISS Medical Technology (148 510(k)s, 5 PMA; 12 applicant names)

FDA device companies by applicant name · FDA product code lookup