This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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 | K254276 | Lynx Aspiration Catheter System | 2026-05-07 |
| US | K240746 | Neurovascular Access System Family | 2024-11-20 |
| US | K222786 | 072 Aspiration System | 2023-08-25 |