Healthcare ranking
Top 15 gastroenterology and urology device companies by FDA clearances 2026
Intuitive Surgical and Olympus share first place with 12 clearances each. The list ranks companies worldwide by the number of clearances assigned to the gastroenterology, urology review panel in that period.
Top 10 at a glance
The full list
| Rank | Company | Headquarters | FDA 510(k) clearances (clearances) |
|---|---|---|---|
| 1 | Intuitive Surgical | United States | 12 |
| 1 | Olympus | Japan | 12 |
| 3 | Karl Storz | Germany | 8 |
| 4 | Fresenius Medical Care | Germany | 7 |
| 5 | Micro-Tech (Nanjing) | China | 6 |
| 6 | BD (Becton, Dickinson and Company) | United States | 5 |
| 6 | Fujifilm | Japan | 5 |
| 8 | Boston Scientific | United States | 4 |
| 8 | Hangzhou AGS MedTech | China | 4 |
| 10 | Nipro | Japan | 3 |
| 10 | Stryker | United States | 3 |
| 10 | Teleflex | United States | 3 |
| 10 | Calyxo | United States | 3 |
| 10 | Ovesco Endoscopy | Germany | 3 |
| 10 | Sonomotion | United States | 3 |
| 10 | Taewoong Medical | South Korea | 3 |
| 10 | Zhejiang Chuangxiang Medical Technology | China | 3 |
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 assigned to the gastroenterology, urology review panel; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Karl Storz SE & CO. KG" and "KALR STORZ SE & Co. KG" are counted as Karl Storz), 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 gastroenterology and urology device companies by FDA clearances ranking?
Intuitive Surgical ranks first with 12 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 assigned to the gastroenterology, urology review panel; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Karl Storz SE & CO. KG" and "KALR STORZ SE & Co. KG" are counted as Karl Storz), 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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