This company has registrations in United States — 1 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 | K071432 | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE | 2008-02-12 |
| US | K071826 | THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 | 2007-11-09 |
| US | K053460 | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, | 2006-01-13 |