Bluewind Medical , Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K252391 | Revi System | December 12, 2025 |
| K240037 | Revi System | May 2, 2024 |
| DEN220073 | Revi System | August 16, 2023 |