Edwards Lifesciences, LLC
FDA 510(k) medical device clearances.
Top product codes for Edwards Lifesciences, LLC
Recent clearances by Edwards Lifesciences, LLC
1–100 of 135- K253186 — HemoSphere Nano Monitor (HSNANO1)
- K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)
- K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)
- K242518 — Hypertension Prediction Index (HePI) Algorithm
- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K240078 — Fogarty Thru-Lumen Embolectomy Catheter
- K233984 — Acumen Assisted Fluid Management (AFM) Software Feature
- K233824 — Swan-Ganz catheter
- K233819 — Fogarty Venous Thrombectomy Catheters
- K230612 — Edwards Algorithm for Measurement of Blood Hemoglobin
- K232294 — HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
- K230919 — Acumen IQ finger cuff
- K230579 — Smart Wedge algorithm
- K231038 — Global Hypoperfusion Index (GHI) Algorithm
- K231035 — FusedCO Algorithm
- K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
- K230057 — Acumen Hypotension Prediction Index (HPI) Algorithm
- K223651 — Cerebral Adaptive Index (CAI) Algorithm
- K222216 — TruWave Disposable Pressure Transducer
- K221704 — HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
- K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module
- K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
- K213682 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
- K211610 — Fogarty Occlusion Catheter
- K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
- K203687 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
- K203490 — FORE-SIGHT ELITE Absolute Tissue Oximeter
- K203131 — EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
- K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
- K200499 — QuickDraw Venous Cannula
- K200358 — Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
- K193466 — Swan-Ganz Catheters
- K193179 — EV1000 Clinical Platform
- K192762 — Physio Flex Annuloplasty Ring
- K192058 — EV1000 Clinical Platform NI, EV1000 Clinical Platform
- K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
- K190130 — The ClearSight finger cuffs
- K191089 — Edwards Pressure Cable
- K182245 — EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
- K180881 — HemoSphere Advanced Monitor, HemoSphere Pressure Cable
- K181684 — VAMP Plus Venous/Arterial Blood Management Protection System
- K180275 — VAMP Optima closed blood sampling system
- K173586 — VAMP Venous/Arterial Blood Management Protection System
- DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software
- K172660 — Duravess bovine pericardial vascular patch
- K171996 — TruWave Disposable Pressure Transducer
- K163381 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
- K163693 — IntraClude Intra-Aortic Occlusion Device
- K161962 — VAMP Venous/Arterial Blood Management Protection System
- K160645 — PreSep Oligon Oximetry Catheter
- K160552 — EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
- K160084 — Swan Ganz Catheters
- K152980 — Flo Trac sensor, Volume View sensor
- K152762 — Fogarty Occlusion Catheter
- K152633 — Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
- K150882 — Edwards Suture Fastening System
- K142749 — TruWave Disposable Pressure Transducer
- K141206 — EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
- K141495 — TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
- K140241 — EDWARDS TRANSFEMORAL BALLOON CATHETER
- K140312 — EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
- K131588 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR
- K131892 — EV1000 CLINICAL PLATFORM
- K140398 — EMBOL-X INTRODUCER SHEATH
- K131627 — CATHETER INTRODUCER SHEATH
- K140208 — FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
- K132175 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- K123714 — EDWARDS EMBOL-X INTRODUCER SHEATH
- K122381 — NEXFIN MODEL 2
- K123303 — FEMORAL ACCESS VENOUS CANNULAE
- K123298 — FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
- K123370 — EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
- K123187 — RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA
- K121185 — EDWARDS PERCUTANEOUS SHEATH INTRODUCER
- K113459 — ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING
- K120780 — EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
- K113411 — EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
- K113565 — MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
- K120072 — VENOUS DRAINAGE CANNULA WITH DURAFLO COATING
- K113667 — CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
- K113182 — EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
- K112694 — EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
- K103520 — CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
- K103094 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
- K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- K110103 — EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
- K100709 — EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
- K100739 — VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
- K102420 — EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA
- K093877 — RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
- K093554 — RETROFLEX DILATOR KIT
- K093911 — FOGARTY OCCLUSION CATHETER
- K093730 — PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
- K091709 — MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
- K092509 — EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
- K083623 — CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
- K083191 — DETLOGIX ANNULOPLASTY RING, MODEL: 5100
- K083470 — CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200
- K082308 — MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K082139 — EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
Data sourced from openFDA. This site is unofficial and independent of the FDA.