The Surgical Company International B.V.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252636 | Fluido Compact System | November 18, 2025 |
| K211618 | Fluido Compact Blood and Fluid Warming System | June 5, 2023 |
| K101705 | MISTRAL-AIR WARMING SYSTEM | July 2, 2010 |