This company has registrations in United States, South Korea, Israel — 3 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 | K232260 | Thinline Sheath Introducer | 2023-09-27 |
| US | K220331 | 091 Balloon Guide Catheter | 2022-07-29 |
| US | K190338 | 046 Zenith Flex | 2019-08-02 |