Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
135
Total
129
Cleared
1
Denied
119 devices
Cleared
Jan 19, 2016
Flo Trac sensor, Volume View sensor
Cardiovascular
102d
Cleared
Nov 23, 2015
Fogarty Occlusion Catheter
Cardiovascular
60d
Cleared
Oct 15, 2015
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar...
Cardiovascular
30d
Cleared
Jan 18, 2015
TruWave Disposable Pressure Transducer
Cardiovascular
116d
Cleared
Sep 03, 2014
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
Cardiovascular
89d
Cleared
Jul 03, 2014
EDWARDS TRANSFEMORAL BALLOON CATHETER
Cardiovascular
154d
Cleared
Jun 13, 2014
EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
Cardiovascular
126d
Cleared
May 22, 2014
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Cardiovascular
356d
Cleared
May 22, 2014
EV1000 CLINICAL PLATFORM
Cardiovascular
331d
Cleared
Mar 19, 2014
EMBOL-X INTRODUCER SHEATH
Cardiovascular
29d
Cleared
Mar 06, 2014
CATHETER INTRODUCER SHEATH
Cardiovascular
275d
Cleared
Mar 05, 2014
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM,...
Cardiovascular
36d
Cleared
Sep 13, 2013
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
Cardiovascular
60d
Cleared
Jul 24, 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
Cardiovascular
232d
Cleared
Apr 22, 2013
NEXFIN MODEL 2
Cardiovascular
259d
Cleared
Mar 22, 2013
FEMORAL ACCESS VENOUS CANNULAE
Cardiovascular
150d
Cleared
Mar 15, 2013
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
Cardiovascular
143d
Cleared
Mar 13, 2013
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING,...
Cardiovascular
132d
Cleared
Feb 22, 2013
RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA...
Cardiovascular
134d
Cleared
Aug 22, 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
Cardiovascular
126d
Cleared
Jun 29, 2012
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA...
Cardiovascular
220d
Cleared
Jun 27, 2012
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
Cardiovascular
105d
Cleared
Jun 11, 2012
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION...
Cardiovascular
206d
Cleared
May 08, 2012
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
Cardiovascular
119d
Cleared
Jan 12, 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
Cardiovascular
30d
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