Healthcare ranking
Top 10 Japanese medical device companies by FDA clearances 2026
Olympus received the most FDA 510(k) clearances of any company headquartered in Japan between 1 November 2025 and 31 October 2026, with 19 clearances. The list ranks Japanese medical device companies by the number of clearances granted in that period.
Top 10 at a glance
The full list
| Rank | Company | FDA 510(k) clearances (clearances) |
|---|---|---|
| 1 | Olympus | 19 |
| 2 | Fujifilm | 18 |
| 3 | Canon | 9 |
| 4 | Terumo | 7 |
| 5 | 3-D Matrix | 4 |
| 5 | GC Corporation | 4 |
| 5 | Nipro | 4 |
| 8 | Topcon | 3 |
| 9 | Kulzer (Mitsui Chemicals) | 2 |
| 9 | Asahi Intecc | 2 |
| 9 | Eizo | 2 |
| 9 | Hamamatsu Photonics | 2 |
| 9 | Menicon | 2 |
| 9 | Nakanishi | 2 |
| 9 | Nihon Kohden | 2 |
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 ("Olympus Medical Systems Corporation" and "Gyrus Acmi, Inc." are counted as Olympus), and government bodies, hospitals and universities are left out. Each company is placed in the country of its headquarters, or of its parent company after merging, so a US subsidiary of a German group counts for Germany. 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 japanese medical device companies by FDA clearances ranking?
Olympus ranks first with 19 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 ("Olympus Medical Systems Corporation" and "Gyrus Acmi, Inc." are counted as Olympus), and government bodies, hospitals and universities are left out. Each company is placed in the country of its headquarters, or of its parent company after merging, so a US subsidiary of a German group counts for Germany. 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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