This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia — 7 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 | K223077 | ViewFlex Xtra ICE Catheter | 2022-12-07 |
| US | K212206 | Jot Dx Insertable Cardiac Monitor | 2021-08-13 |
| US | K202876 | Confirm Rx Insertable Cardiac Monitor | 2020-12-01 |
| BR | 10332340052 | CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803 | Class II |
| BR | 10332340052 | CONJUNTO DE MEDIDORES PARA BIOPROTESE VALVARCARDIACA MODELO B803 | Class II |
| BR | 10332340275 | SISTEMA ENSITE VELOCITY | Class II |
| SA | ME0000001187SFDAA00002 | Transducer Cable | — |
| SA | ME0000001187SFDAA00003 | TactiSys Quartz, TactiFlex Radiofrequency Cable | — |
| CA | 189 | AFFINITY PULSE GENERATORS | Class IV |
| CA | 528 | PROFILE IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR SYSTEM | Class IV |
| CA | 583 | VENTRITEX PR 1500 PROGRAMMER | Class IV |