Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
135
Total
129
Cleared
1
Denied
119 devices
Cleared
Dec 07, 2011
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
Cardiovascular
40d
Cleared
Oct 14, 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
Cardiovascular
29d
Cleared
Jun 24, 2011
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
Cardiovascular
206d
Cleared
May 17, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
Cardiovascular
210d
Cleared
Feb 18, 2011
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
Cardiovascular
29d
Cleared
Feb 11, 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
Cardiovascular
29d
Cleared
Dec 07, 2010
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
Cardiovascular
270d
Cleared
Dec 07, 2010
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
Cardiovascular
266d
Cleared
Oct 26, 2010
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC...
Cardiovascular
62d
Cleared
Jul 01, 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
Cardiovascular
197d
Cleared
Apr 13, 2010
RETROFLEX DILATOR KIT
Cardiovascular
147d
Cleared
Jan 21, 2010
FOGARTY OCCLUSION CATHETER
Cardiovascular
30d
Cleared
Jan 14, 2010
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
Cardiovascular
42d
Cleared
Oct 08, 2009
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
Cardiovascular
52d
Cleared
Apr 15, 2009
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
Cardiovascular
128d
Cleared
Apr 10, 2009
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
Cardiovascular
163d
Cleared
Jan 23, 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
Cardiovascular
60d
Cleared
Dec 09, 2008
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Cardiovascular
118d
Cleared
Oct 23, 2008
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
Cardiovascular
86d
Cleared
Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Cardiovascular
27d
Cleared
Apr 28, 2006
PRESEP OLIGON OXIMETRY CATHETERS
Cardiovascular
106d
Cleared
Apr 25, 2006
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
Cardiovascular
43d
Cleared
Feb 28, 2006
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC...
Cardiovascular
63d
Cleared
Dec 30, 2005
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
Cardiovascular
65d
Cleared
Sep 02, 2005
EDWARDS PERIPHERAL DILATION CATHETER
Cardiovascular
25d
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