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 | K060648 | REPROCESSED PHACOEMULSIFICATION TIPS | 2007-03-19 |
| US | K061045 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | 2006-08-31 |
| US | K051438 | VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) | 2006-04-04 |
| CA | 6894 | ECHO 1000 | Class II |
| CA | 7409 | AKHO 5000 | Class II |
| CA | 8271 | AMIB7 | Class II |