Medical Device Manufacturer · US , Irvine , CA

Edwards Lifesiences, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Edwards Lifesiences, LLC Cardiovascular ✕
2 devices
1-2 of 2
Cleared Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
K222117 · DYG
Cardiovascular · 144d
Cleared Oct 01, 2020
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
K201446 · DQK
Cardiovascular · 122d
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