Healthcare ranking
Top 15 South Korean medical device companies by FDA clearances 2026
Samsung (Samsung Medison) received the most FDA 510(k) clearances of any company headquartered in South Korea between 1 November 2025 and 31 October 2026, with 10 clearances. The list ranks South Korean 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 | Samsung (Samsung Medison) | 10 |
| 2 | Mediclus | 8 |
| 3 | DiaDent Group International | 6 |
| 3 | L&K Biomed | 6 |
| 5 | Spident | 5 |
| 6 | Uzinmedicare | 4 |
| 7 | Osstem Implant | 3 |
| 7 | AIRS Medical | 3 |
| 7 | LG Electronics | 3 |
| 7 | Medyssey | 3 |
| 7 | Neurophet | 3 |
| 7 | Speclipse | 3 |
| 7 | Taewoong Medical | 3 |
| 7 | Tdm | 3 |
| 7 | Vieworks | 3 |
| 7 | VPIX Medical | 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; De Novo grants are not counted. Clearances held by subsidiaries and under name variants are merged into the parent company ("Samsung Medison Co., Ltd." and "NeuroLogica Corp., a Samsung Company" are counted as Samsung (Samsung Medison)), 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 south Korean medical device companies by FDA clearances ranking?
Samsung (Samsung Medison) ranks first with 10 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 ("Samsung Medison Co., Ltd." and "NeuroLogica Corp., a Samsung Company" are counted as Samsung (Samsung Medison)), 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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