Edwards Lifesciences - FDA 510(k) Cleared Devices
20
Total
19
Cleared
1
Denied
19 devices
Cleared
Apr 17, 2026
Edwards eSheath+ introducer set
Cardiovascular
108d
Cleared
Dec 18, 2025
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1
Cardiovascular
128d
Cleared
Oct 21, 2025
HemoSphere Stream Module
Cardiovascular
29d
Cleared
Aug 29, 2025
Edwards eSheath Optima introducer set
Cardiovascular
31d
Cleared
Jul 23, 2025
HemoSphere Advanced Monitor (HEM1)
Cardiovascular
226d
Cleared
Mar 27, 2025
Edwards eSheath Optima introducer set
Cardiovascular
87d
Cleared
Dec 09, 2024
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
Cardiovascular
115d
Cleared
Jul 02, 2024
Fogarty Fortis Arterial Embolectomy Catheter
Cardiovascular
53d
Cleared
Jun 27, 2024
Swan-Ganz Pacing Probe and Catheters
Cardiovascular
192d
Cleared
May 22, 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
Cardiovascular
173d
Cleared
May 20, 2024
Fogarty Corkscrew Catheters
Cardiovascular
189d
Cleared
Feb 05, 2024
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A,...
Cardiovascular
56d