This company has registrations in United States, Israel — 2 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K203117 | TissueTak device | 2021-01-07 |
| US | K181668 | FasTouch Absorbable Fixation System | 2019-03-13 |
| US | K162252 | FasTouch Fixation System | 2016-11-14 |