Mc3 Inc
Mc3 Inc appears in FDA public data with 2 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1310-2024, Class II) was initiated on October 11, 2023. Its most recent 510(k) clearance was granted on October 4, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1310-2024 | Class II | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures | October 11, 2023 |
| Z-1309-2024 | Class II | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to | October 11, 2023 |