Medical Device Manufacturer · US , Irvine , CA

Edwards Lifesciences, LLC - FDA 510(k) Cleared Devices

135 submissions · 129 cleared · Since 1979
135
Total
129
Cleared
1
Denied
135 devices
76-100 of 135
Cleared Jun 27, 2012
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
K120780 · DWF
Cardiovascular · 105d
Cleared Jun 11, 2012
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION...
K113411 · DWF
Cardiovascular · 206d
Cleared May 18, 2012
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX...
K113565 · FOZ
General Hospital · 168d
Cleared May 08, 2012
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
K120072 · DWF
Cardiovascular · 119d
Cleared Jan 12, 2012
CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
K113667 · DTL
Cardiovascular · 30d
Cleared Dec 07, 2011
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · DXC
Cardiovascular · 40d
Cleared Oct 14, 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · DXC
Cardiovascular · 29d
Cleared Jun 24, 2011
CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
K103520 · KRH
Cardiovascular · 206d
Cleared May 17, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
K103094 · DXG
Cardiovascular · 210d
Cleared Feb 18, 2011
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · DQE
Cardiovascular · 29d
Cleared Feb 11, 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · DQO
Cardiovascular · 29d
Cleared Dec 07, 2010
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
K100709 · DXG
Cardiovascular · 270d
Cleared Dec 07, 2010
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · KRB
Cardiovascular · 266d
Cleared Oct 26, 2010
EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC...
K102420 · DWF
Cardiovascular · 62d
Cleared Jul 01, 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · DYB
Cardiovascular · 197d
Cleared Apr 13, 2010
RETROFLEX DILATOR KIT
K093554 · DRE
Cardiovascular · 147d
Cleared Jan 21, 2010
FOGARTY OCCLUSION CATHETER
K093911 · MJN
Cardiovascular · 30d
Cleared Jan 14, 2010
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
K093730 · DWF
Cardiovascular · 42d
Cleared Oct 13, 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709 · FOZ
General Hospital · 125d
Cleared Oct 08, 2009
EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
K092509 · DWF
Cardiovascular · 52d
Cleared Apr 15, 2009
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
K083623 · KRH
Cardiovascular · 128d
Cleared Apr 10, 2009
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · KRH
Cardiovascular · 163d
Cleared Jan 23, 2009
CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
K083470 · KRH
Cardiovascular · 60d
Cleared Dec 09, 2008
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K082308 · DXG
Cardiovascular · 118d
Cleared Oct 23, 2008
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · DXZ
Cardiovascular · 86d

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