This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Israel — 6 overseas markets. The China NMPA lookup is still pending.
Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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 | K131035 | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM | 2013-07-02 |
| US | K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | 2013-03-29 |
| US | K121890 | GENESYS PRESSFT SUTURE ANCHOR | 2012-08-22 |
| CA | 538 | MINI TRAUMA | Class II |
| CA | 735 | C7050 IRRIGATION SYSTEM | Class II |
| CA | 2538 | LAPAROSCOPES | Class II |
Signed in · open all 18 sampled records for this company and export → · Export rows left this month —/100