This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | 2024-05-23 |
| US | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | 2020-07-08 |
| US | K200390 | V.A.C. DERMATAC Drape | 2020-05-18 |
| BR | 80624969001 | CURATIVO PREVENA PLUS CUSTOMIZABLE COM A TECNOLOGIA SENSAT.R.A.C. | Class II |
| BR | 80624960006 | Canister Info V.A.C. com gel | Class II |
| BR | 80624960009 | Canister Info V.A.C. | Class II |
| SA | ME0000001315SFDAA00001 | CelluTome™ Control Unit Stand | — |
| CA | 63025 | BARIAIR | Class II |
| CA | 27982 | PEDIDYNE KINETIC AND LOW AIRLOSS THERAPY | Class II |
| CA | 60084 | PARADYNE | Class II |