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 | K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM | 2006-05-15 |
| US | K022008 | CARDIMA ABLATION SYSTEM | 2003-01-29 |
| US | K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER | 1999-06-22 |
| CA | 2244 | THE PATHFINDER .020 SERIES | Class IV |
| CA | 2465 | EP SELECT SWITCHBOX | Class II |
| CA | 2613 | FORERUNNER GUIDING CATHETER | Class II |