Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
135
Total
129
Cleared
1
Denied
135 devices
Cleared
Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Cardiovascular
27d
Cleared
Jun 05, 2006
LIFESTENT TURBO BILIARY STENT SYSTEM
Gastroenterology & Urology
33d
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
Mar 23, 2006
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
Gastroenterology & Urology
27d
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
Dec 21, 2005
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
Gastroenterology & Urology
14d
Cleared
Sep 02, 2005
EDWARDS PERIPHERAL DILATION CATHETER
Cardiovascular
25d
Cleared
Aug 24, 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
Gastroenterology & Urology
19d
Cleared
Mar 22, 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
Gastroenterology & Urology
11d
Cleared
Jan 26, 2005
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND...
Cardiovascular
82d
Cleared
Dec 23, 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
Gastroenterology & Urology
55d
Cleared
Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
Cardiovascular
30d
Cleared
Sep 29, 2004
EDWARDS E360 SURGICAL ABLATION DEVICE
General & Plastic Surgery
93d
Cleared
Jul 28, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
Cardiovascular
271d
Cleared
Jun 22, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
Cardiovascular
235d
Cleared
Apr 26, 2004
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME...
Cardiovascular
80d
Cleared
Dec 30, 2003
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
General Hospital
84d
Cleared
Dec 04, 2003
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED...
Cardiovascular
78d
Cleared
Nov 03, 2003
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
Cardiovascular
132d
Cleared
Oct 02, 2003
EDWARDS PERIPHERAL DILATATION CATHETER
Cardiovascular
41d
Cleared
Sep 03, 2003
EDWARDS DIRECTIONAL CATHETER
Cardiovascular
188d
Cleared
Aug 26, 2003
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
Cardiovascular
35d
Cleared
Jul 03, 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY...
Gastroenterology & Urology
191d
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