Is this your brand? Sign in to claim ownership.
Sign in to claim this brandVirtual Incision
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mira | 180-000000-000 | FDA UDI | Class II | Active |
| Mira | 180-070000-000 | FDA UDI | Class II | Active |
| Mira | 180-010000-000 | FDA UDI | Class II | Active |
| Mira | 180-020000-000 | FDA UDI | Class II | Active |
| Mira | 180-040000-000 | FDA UDI | Class II | Active |
| Mira | 180-090000-000 | FDA UDI | Class II | Active |
| Mira | 180-050000-101 | FDA UDI | Class II | Active |
| Mira | 180-080000-000 | FDA UDI | Class II | Active |
| Mira | 180-130000-100 | FDA UDI | Class II | Active |
| Mira | 180-050000-102 | FDA UDI | Class II | Active |
| MIRA Surgical System | DEN230025 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 23, 2025 | Z-1905-2025 | — | completed | 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, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms. |