Edwards Lifeciences, LLC

FDA Regulatory Profile

Edwards Lifeciences, LLC appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 7, 2022.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableNovember 7, 2022
K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index May 21, 2019
K183413TruWave Disposable Pressure TransducerMay 1, 2019