This company has registrations in United States, Brazil, Saudi Arabia — 3 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 | K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM | 2024-06-18 |
| US | K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) | 2023-01-20 |
| US | K152996 | Molteno3 Glaucoma Implant | 2015-12-17 |
| BR | 83037060001 | Acessório Estéril para Posicionador de Joelho Modular - Mayo Adapt2Fit | Class I |
| BR | 83037060002 | Posicionador de Joelho Modular - Mayo Adapt2Fit - Innovative Medical. | Class I |
| BR | 83037060004 | Posicionador de Quadril para Acesso Lateral - MorphBoard - Innovative | Class I |
| SA | ME0000005418SFDAA00001 | IMP DEMAYI LEG WRAP | — |
| SA | ME0000005418SFDAA00002 | IMP OR TABLE ARM PADS | — |