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 | K101113 | GUARDIAN II NC HEMOSTASIS VALVE | 2010-05-21 |
| US | K092711 | GUARDIAN II HEMOSTASIS VALVE | 2009-10-01 |
| US | K073620 | GUARDIAN HEMOSTASIS VALVE | 2008-02-27 |