Healthcare ranking
Top 25 medical device companies by FDA clearances 2026
Medtronic received the most FDA 510(k) clearances between 1 November 2025 and 31 October 2026, with 50 clearances. The list ranks medical device companies worldwide by the number of clearances granted in that period.
Top 10 at a glance
The full list
| Rank | Company | Headquarters | FDA 510(k) clearances (clearances) |
|---|---|---|---|
| 1 | Medtronic | Ireland | 50 |
| 2 | Siemens Healthineers | Germany | 46 |
| 3 | Stryker | United States | 43 |
| 4 | Johnson & Johnson MedTech | United States | 32 |
| 5 | GE HealthCare | United States | 31 |
| 5 | Philips | Netherlands | 31 |
| 7 | Zimmer Biomet | United States | 28 |
| 8 | Roche | Switzerland | 24 |
| 9 | Danaher | United States | 21 |
| 10 | Arthrex | United States | 19 |
| 10 | Karl Storz | Germany | 19 |
| 10 | Olympus | Japan | 19 |
| 13 | BD (Becton, Dickinson and Company) | United States | 18 |
| 13 | Boston Scientific | United States | 18 |
| 13 | Fujifilm | Japan | 18 |
| 16 | Abbott | United States | 17 |
| 17 | Intuitive Surgical | United States | 13 |
| 18 | Dentsply Sirona | United States | 11 |
| 18 | Medacta | Switzerland | 11 |
| 20 | Globus Medical | United States | 10 |
| 20 | Merit Medical Systems | United States | 10 |
| 20 | Mindray | China | 10 |
| 20 | Samsung (Samsung Medison) | South Korea | 10 |
| 20 | United Imaging Healthcare | China | 10 |
| 25 | Canon | Japan | 9 |
| 25 | Smith & Nephew | United Kingdom | 9 |
| 25 | bioMérieux | France | 9 |
| 25 | CMT Health PTE | Singapore | 9 |
| 25 | SurGenTec | United States | 9 |
How this list is built
We counted FDA 510(k) clearances (substantially equivalent decisions) with a decision date from 1 November 2025 to 31 October 2026; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Medtronic, Inc." and "Covidien, LLC" are counted as Medtronic), and government bodies, hospitals and universities are left out. Companies with the same count share a rank, and all companies tied at the last place are shown.
Every position is set by the data alone, by the same rules for every company. Spotted something to update? Write to info@stratummarketresearch.com with the list and the line, and we correct it within two working days.
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Frequently asked questions
Who is number one in the medical device companies by FDA clearances ranking?
Medtronic ranks first with 50 clearances (1 November 2025 to 31 October 2026).
How is this ranking calculated?
We counted FDA 510(k) clearances (substantially equivalent decisions) with a decision date from 1 November 2025 to 31 October 2026; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Medtronic, Inc." and "Covidien, LLC" are counted as Medtronic), and government bodies, hospitals and universities are left out. Companies with the same count share a rank, and all companies tied at the last place are shown.
Can a company pay to rank higher?
Positions come only from the counts described above, and inclusion is free. Every company is ranked by the same rules.
How often is the ranking updated?
Every list is recomputed each quarter from the latest public records, and the update date is printed on the page.
Can a ranked company use the badge?
Yes. Every ranked company can use the free web badge on this page on its website, in press releases and on social media.
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