Eden Prairie, MN, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2026-05-14 |
| NEU | Marker, Radiographic, Implantable | Class II | General, Plastic Surgery | 1 | 2024-12-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-11-18 | Class II | Ongoing | Z-0806-2025 | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad … | — | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 oper… |