This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Hong Kong, Israel, Russia — 10 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 | K160744 | LOOK PTFE Suture | 2016-07-13 |
| US | K141778 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN | 2014-07-30 |
| US | K141625 | POLYSYN SURGICAL SUTURE | 2014-07-18 |
| BR | 80192010077 | BISTURIS MICROCIRÚRGICOS STYLUS | Class II |
| BR | 80147060162 | Sharpoint Microsurgical Knife / bisturi cirúrgico Sharpoint - Clear Co | Class II |
| BR | 80147060161 | Sharpguard Guarded Knife / Bisturi cirúrgico com Protetor de Lâmina S | Class II |
| SA | ME0000002304SFDAA00002 | Reliant 600 | — |
| SA | ME0000002304SFDAA00001 | Reliant 450 | — |
| CA | 19556 | SURGICAL KNIVES - SINGLE USE | Class II |
| CA | 19558 | SHARPOINT OPHTHALMIC CANNULAE-STAINLESS STEEL | Class II |
| CA | 38074 | E-CAPROLACTONE-L-LACTIDE COPOLYMER SUTURES (PCL) | Class III |