Lincoln, NE, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| SAB | — | — | — | 1 | 2024-02-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-04-23 | Class II | Completed | Z-1905-2025 | MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Softwar… | — | The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-02-23 | DEN230025 | MIRA Surgical System | SAB | — | — |