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 | K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | 2004-07-23 |
| US | K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE | 2003-05-21 |
| US | K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | 2003-01-06 |
| CA | 263 | RADIUS SELF-EXPANDING STENT WITH OVER-THE-WIRE (OTW) DELIVERY SYSTEM | Class IV |
| CA | 264 | RADIUS SELF-EXPANDING STENT WITH SINGLE OPERATOR EXCHANGE DELIVERY SYSTEM | Class IV |
| CA | 5015 | DISCOVERY CORONARY IMAGING CATHETER | Class IV |