This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Australia — 6 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 | K250512 | Augmented Gingival Matrix | 2025-12-05 |
| US | K243693 | NEO Pedicle Screw System | 2024-12-23 |
| US | K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | 2022-08-26 |
| BR | 80114540017 | Esponja Nasal | Class I |
| SA | ME0000000077SFDAA00001 | Face mask disposable | — |
| SA | ME0000000076SFDAA00002 | Vinyl disposable gloves | — |
| CA | 84602 | V-CATH PICC CATHETER ONLY | Class III |