Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
135
Total
129
Cleared
1
Denied
119 devices
Cleared
Jan 22, 2021
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000...
Cardiovascular
95d
Cleared
Jun 12, 2020
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
Cardiovascular
190d
Cleared
Mar 29, 2020
QuickDraw Venous Cannula
Cardiovascular
30d
Cleared
Mar 13, 2020
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula,...
Cardiovascular
29d
Cleared
Feb 16, 2020
Swan-Ganz Catheters
Cardiovascular
62d
Cleared
Dec 17, 2019
EV1000 Clinical Platform
Cardiovascular
29d
Cleared
Dec 16, 2019
Physio Flex Annuloplasty Ring
Cardiovascular
77d
Cleared
Aug 30, 2019
EV1000 Clinical Platform NI, EV1000 Clinical Platform
Cardiovascular
29d
Cleared
Aug 29, 2019
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
Cardiovascular
206d
Cleared
Jun 21, 2019
The ClearSight finger cuffs
Cardiovascular
144d
Cleared
Jun 13, 2019
Edwards Pressure Cable
Cardiovascular
50d
Cleared
Nov 30, 2018
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or...
Cardiovascular
102d
Cleared
Nov 16, 2018
HemoSphere Advanced Monitor, HemoSphere Pressure Cable
Cardiovascular
226d
Cleared
Nov 08, 2018
VAMP Plus Venous/Arterial Blood Management Protection System
Cardiovascular
135d
Cleared
Oct 24, 2018
VAMP Optima closed blood sampling system
Cardiovascular
266d
Cleared
Apr 05, 2018
VAMP Venous/Arterial Blood Management Protection System
Cardiovascular
136d
Not Cleared
Mar 16, 2018
Acumen Hypotension Prediction Index (HPI) Feature Software
Cardiovascular
536d
Cleared
Nov 17, 2017
Duravess bovine pericardial vascular patch
Cardiovascular
73d
Cleared
Oct 23, 2017
TruWave Disposable Pressure Transducer
Cardiovascular
112d
Cleared
Apr 14, 2017
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
Cardiovascular
134d
Cleared
Jan 26, 2017
IntraClude Intra-Aortic Occlusion Device
Cardiovascular
29d
Cleared
Nov 28, 2016
VAMP Venous/Arterial Blood Management Protection System
Cardiovascular
133d
Cleared
Jun 16, 2016
PreSep Oligon Oximetry Catheter
Cardiovascular
101d
Cleared
Jun 01, 2016
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System,...
Cardiovascular
93d
Cleared
May 03, 2016
Swan Ganz Catheters
Cardiovascular
109d
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