This company has registrations in United States, Brazil, Taiwan, South Korea, Russia — 5 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 | K240917 | Esperance 3+ Aspiration Catheter System | 2024-10-01 |
| US | K231056 | Esperance Distal Access Catheter | 2024-03-08 |
| US | K232437 | Paragon 8F Balloon Guide Catheter | 2023-10-13 |