This company has registrations in United States, Canada — 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 | K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | 2025-10-20 |
| US | DEN190038 | Surfacer Inside-Out Access Catheter System | 2020-02-10 |
| US | K150389 | Spiral Flow Peripheral Vascular Graft | 2015-05-06 |