Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices
135
Total
129
Cleared
1
Denied
119 devices
Cleared
Jan 26, 2005
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND...
Cardiovascular
82d
Cleared
Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
Cardiovascular
30d
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 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
Jun 20, 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
Cardiovascular
86d
Cleared
Apr 24, 2003
EDWARDS INTRODUCER SHEATH
Cardiovascular
17d
Cleared
Apr 17, 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
Cardiovascular
30d
Cleared
Apr 11, 2002
AXILLARY ACCESS ARTERIAL CANNULA
Cardiovascular
601d
Cleared
Mar 08, 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
Cardiovascular
88d
Cleared
Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
Cardiovascular
88d
Cleared
Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
Cardiovascular
292d
Cleared
Aug 10, 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT,...
Cardiovascular
83d
Cleared
Jul 12, 1979
SWAN-GANZ FLOW-DIRECTED CATHETER
Cardiovascular
17d
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