This company has registrations in United States, Canada — 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 | K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 | 2006-07-27 |
| US | K061453 | HI-TORQUE WHISPER VIEW GUIDE WIRE | 2006-06-22 |
| US | K060449 | HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE | 2006-05-30 |
| CA | 61745 | MULTI-LINK VISION CORONARY STENTS | Class IV |
| CA | 28069 | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Class IV |
| CA | 36464 | GALILEO III CENTERING CATHETERS | Class IV |