Edwards Lifesiences, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K222117 | Swang-Ganz IQ pulmonary artery catheter | December 9, 2022 |
| K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | October 1, 2020 |