This company has registrations in United States, Canada, 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 | K182463 | Silicone Foley Catheter | 2019-11-06 |
| US | K070710 | ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM | 2007-04-19 |
| US | K022004 | CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 | 2003-03-12 |
| CA | 70730 | THERMODILUTION, PULMONARY ARTERY MONITORING CATHETERS | Class IV |
| CA | 84253 | EMBOLECTOMY CATHETER (PVC TUBING) | Class II |
| CA | 84732 | EMBOLECTOMY CATHETER (NYLON TUBING) | Class II |