This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Israel — 6 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 | K141354 | NAVAJO PTA BALLOON DILATATION CATHETER | 2015-01-30 |
| US | K130828 | K SERIES CPAP SYSTEMS | 2014-01-13 |
| US | K131702 | K SERIES CPAP SYSTEMS | 2013-12-06 |
| BR | 80160710023 | CATETER PARA ANGIO TRANSLUMINAL PERCUT URSA | Class II |