Edward Lifesciences, Llc
FDA Regulatory Profile
Edward Lifesciences, Llc appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2776-2015, Class II) was initiated on July 31, 2015. Its most recent 510(k) clearance was granted on September 2, 2016.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2776-2015 | Class II | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use | July 31, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162184 | Edwards eSheath Introducer Set | September 2, 2016 |