Edwards Lifesciences, LLC
Edwards Lifesciences, LLC holds FDA 510(k) medical device clearances, first cleared 1979, most recent 2026, with 95 FDA device recalls on record.
Clearances by Edwards Lifesciences, LLC — page 2
101–136 of 136- K082139 — EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
- K062134 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K061235 — LIFESTENT TURBO BILIARY STENT SYSTEM
- K060093 — PRESEP OLIGON OXIMETRY CATHETERS
- K060660 — EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
- K060487 — LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
- K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K053016 — WIRELESS PHYSIOLOGIC MONITORING SYSTEM
- K053404 — LIFESTENT FLEXSTART BILIARY STENT SYSTEM
- K052149 — EDWARDS PERIPHERAL DILATION CATHETER
- K052132 — MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
- K050627 — LIFESTENT TURBO BILIARY STENT SYSTEMS
- K043065 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P
- K042985 — LIFESTENT NT35 BILIARY STENT SYSTEM
- K043103 — VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
- K041739 — EDWARDS E360 SURGICAL ABLATION DEVICE
- K033463 — EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
- K033464 — EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
- K040287 — VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
- K033250 — EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
- K032900 — LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
- K031946 — EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
- K032587 — EDWARDS PERIPHERAL DILATATION CATHETER
- K030630 — EDWARDS DIRECTIONAL CATHETER
- K032250 — GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
- K024303 — EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
- K030944 — EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
- K031087 — EDWARDS INTRODUCER SHEATH
- K020864 — EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
- K002578 — AXILLARY ACCESS ARTERIAL CANNULA
- K014052 — EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
- K014054 — EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
- K013990 — LIFESTITCH SUTURING DEVICE
- K001734 — FOGARTY VALVULOTOME, MODEL 700091
- K001565 — STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
- K791183 — SWAN-GANZ FLOW-DIRECTED CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.