Edwards Lifesciences - FDA 510(k) Cleared Devices
Recent clearances: Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts, Edwards eSheath+ introducer set, HemoSphere Alta Advanced Monitoring Platform (ALTAALL1
22
Total
21
Cleared
1
Denied
FDA 510(k) Regulatory Record - Edwards Lifesciences Cardiovascular ✕
21 devices
Cleared
Jun 26, 2026
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135)
Cardiovascular
179d
Cleared
Jun 05, 2026
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
Cardiovascular
143d
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
Not Cleared
Nov 13, 2020
Acumen Assisted Fluid Management (AFM) Software Feature
Cardiovascular
529d
Cleared
Mar 09, 2020
Edwards eSheath Introducer Set
Cardiovascular
35d
Cleared
Jan 07, 2016
Edwards Balloon Catheter
Cardiovascular
77d
Cleared
Nov 24, 2015
Edwards eSheath Introducer Set
Cardiovascular
109d
Cleared
Oct 29, 2014
Ascendra Balloon Aortic Valvaloplasty Catheter
Cardiovascular
79d
Cleared
Sep 18, 2014
EDWARDS ESHEATH INTRODUCER SET
Cardiovascular
86d
Cleared
Jun 14, 2011
EV1000 CLINICAL PLATFORM
Cardiovascular
104d