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 | K092174 | ENABLER-P CATHETER SYSTEM, MODEL 3000 | 2009-12-30 |
| US | K083833 | ENABLER-P CATHETER, 1000 PART NUMBER:1160 | 2009-05-22 |
| US | K082339 | ENABLER-P SUPPORT CATHETER | 2008-11-20 |