Atlas FDA

Edwards Lifesciences, LLC

136 FDA 510(k) clearances · Manufacturer

Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 (K082139)Edwards Lifesciences, LLC2008-10-23
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K062134)Edwards Lifesciences, LLC2006-08-22
LIFESTENT TURBO BILIARY STENT SYSTEM (K061235)Edwards Lifesciences, LLC2006-06-05
PRESEP OLIGON OXIMETRY CATHETERS (K060093)Edwards Lifesciences, LLC2006-04-28
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER (K060660)Edwards Lifesciences, LLC2006-04-25
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM (K060487)Edwards Lifesciences, LLC2006-03-23
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609)Edwards Lifesciences, LLC2006-02-28
WIRELESS PHYSIOLOGIC MONITORING SYSTEM (K053016)Edwards Lifesciences, LLC2005-12-30
LIFESTENT FLEXSTART BILIARY STENT SYSTEM (K053404)Edwards Lifesciences, LLC2005-12-21
EDWARDS PERIPHERAL DILATION CATHETER (K052149)Edwards Lifesciences, LLC2005-09-02
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM (K052132)Edwards Lifesciences, LLC2005-08-24
LIFESTENT TURBO BILIARY STENT SYSTEMS (K050627)Edwards Lifesciences, LLC2005-03-22
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P (K043065)Edwards Lifesciences, LLC2005-01-26
LIFESTENT NT35 BILIARY STENT SYSTEM (K042985)Edwards Lifesciences, LLC2004-12-23
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 (K043103)Edwards Lifesciences, LLC2004-12-09
EDWARDS E360 SURGICAL ABLATION DEVICE (K041739)Edwards Lifesciences, LLC2004-09-29
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE (K033463)Edwards Lifesciences, LLC2004-07-28
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE (K033464)Edwards Lifesciences, LLC2004-06-22
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR (K040287)Edwards Lifesciences, LLC2004-04-26
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR (K033250)Edwards Lifesciences, LLC2003-12-30
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS (K032900)Edwards Lifesciences, LLC2003-12-04
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE (K031946)Edwards Lifesciences, LLC2003-11-03
EDWARDS PERIPHERAL DILATATION CATHETER (K032587)Edwards Lifesciences, LLC2003-10-02
EDWARDS DIRECTIONAL CATHETER (K030630)Edwards Lifesciences, LLC2003-09-03
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 (K032250)Edwards Lifesciences, LLC2003-08-26
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM (K024303)Edwards Lifesciences, LLC2003-07-03
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K030944)Edwards Lifesciences, LLC2003-06-20
EDWARDS INTRODUCER SHEATH (K031087)Edwards Lifesciences, LLC2003-04-24
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 (K020864)Edwards Lifesciences, LLC2002-04-17
AXILLARY ACCESS ARTERIAL CANNULA (K002578)Edwards Lifesciences, LLC2002-04-11
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K014052)Edwards Lifesciences, LLC2002-03-08
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL (K014054)Edwards Lifesciences, LLC2002-03-08
LIFESTITCH SUTURING DEVICE (K013990)Edwards Lifesciences, LLC2002-02-27
FOGARTY VALVULOTOME, MODEL 700091 (K001734)Edwards Lifesciences, LLC2001-03-26
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB (K001565)Edwards Lifesciences, LLC2000-08-10
SWAN-GANZ FLOW-DIRECTED CATHETER (K791183)Edwards Lifesciences, LLC1979-07-12
← Previous

Track Edwards Lifesciences, LLC automatically

Every clearance here is in the API, with alerts when new ones post.