Edwards Lifeciences, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Edwards Lifeciences, LLC - FDA 510(k) Cleared Devices
Recent clearances: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable, Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure, TruWave Disposable Pressure Transducer
3
Total
3
Cleared
0
Denied
Edwards Lifeciences, LLC has 3 FDA 510(k) cleared medical devices. Based in Irvine, US.
Last cleared in 2022. Active since 2019. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Edwards Lifeciences, LLC Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Edwards Lifeciences, LLC
3 devices
Cleared
Nov 07, 2022
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Cardiovascular
35d
Cleared
May 21, 2019
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen...
Cardiovascular
146d
Cleared
May 01, 2019
TruWave Disposable Pressure Transducer
Cardiovascular
142d