Edmonton, CA · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FXX | — | — | — | 2 | 2025-11-04 |
| FRG | Wrap, Sterilization | Class II | General Hospital | 2 | 2024-10-07 |
| OXZ | Pediatric/Child Facemask | Class II | General, Plastic Surgery | 1 | 2022-11-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-04 | K252964 | PRIMED Surgical and Procedure Masks | FXX | — | — |
| 2024-10-07 | K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | Class II | General Hospital |
| 2024-08-26 | K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | FXX | — | — |
| 2024-05-24 | K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | Class II | General Hospital |
| 2022-11-22 | K213427 | PRIMED Pediatric Facemask | OXZ | Class II | General, Plastic Surgery |