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Edwards Lifesciences LLC

Last updated September 17, 2026

What Edwards Lifesciences LLC makes

Edwards Lifesciences LLC manufactures single-use and reusable invasive-pressure transducers, electrical connection cables, and arterial blood sampling kits for clinical monitoring. Their portfolio includes open-surgery and transcatheter aortic heart valves, cardiopulmonary bypass cannulae for drainage and return, and pulmonary artery balloon catheters with electrical functionality. Additional products include retrograde cardioplegia catheters, femoral arterial cannulae, and continuous cardiac output monitoring sensors.

The company’s devices are classified under FDA categories Class I, Class II, and Class III, with listings in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: ONE EDWARDS WAY, IRVINE, CA, 92614
Website: edwards.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)822-9637
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2015691
DUNS Number: 134139174

Catalogue (1779)

Page 35 of 36

Device	Model / Reference	Registries	Class	Status
Vigileo Arterial Pressure Cardiac Output / Oximetry Monitor; Vigileo Apco / Oximetry Monitor	K103094	FDA 510(k)	Class II	Active
TruWave Disposable Pressure Transducer	K222216	FDA 510(k)	Class II	Active
Retrograde Coronary Sinus Cardioplegia Catheter, Retrograde Cardioplegia Catheter, Retrograde Cardioplegia Cannula	K123187	FDA 510(k)	Class II	Active
Lifestent Turbo Biliary Stent System	K061235	FDA 510(k)	Class II	Active
Fogarty Arterial Embolectomy Catheter with Gate Valve	K233820	FDA 510(k)	Class II	Active
Swan-Ganz Catheters	K193466	FDA 510(k)	Class II	Active
Carpentier-Edwards Physio Tricuspid Annuloplasty Ring	K103520	FDA 510(k)	Class II	Active
Volumeview System, Models Vlv520ft6r, Vlv520ft8r, Vlv520ft6r5	K100739	FDA 510(k)	Class II	Active
Swan-Ganz Flow-Directed Catheter	K791183	FDA 510(k)	Class II	Active
Acumen Assisted Fluid Management (AFM) Software Feature	DEN190029	FDA 510(k)	Class II	Active
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors	K242909	FDA 510(k)	Class II	Active
Swang-Ganz IQ pulmonary artery catheter	K222117	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module	K201446	FDA 510(k)	Class II	Active
Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor	K062134	FDA 510(k)	Class II	Active
QuickDraw Venous Cannula	K200499	FDA 510(k)	Class II	Active
Detlogix Annuloplasty Ring, Model: 5100	K083191	FDA 510(k)	Class II	Active
Embol-X Intra-Aortic Filter: Extra-Small, Small, Medium, Large, Extra-Large	K031946	FDA 510(k)	Class II	Active
Acumen Assisted Fluid Management (AFM) Software Feature	K233984	FDA 510(k)	Class II	Active
Truwave Disposable Pressure Transducer	K141495	FDA 510(k)	Class II	Active
Edwards Percutaneous Sheath Introducer	K121185	FDA 510(k)	Class II	Active
Lifespan Reinforced Eptfe Straight Vascular Grafts, Externally Supported Vascular Grafts, Stepped Vascular Grafts	K032900	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)	K243781	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable	K163381	FDA 510(k)	Class II	Active
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula	K200358	FDA 510(k)	Class II	Active
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)	K172423	FDA 510(k)	Class II	Active
Edwards eSheath Introducer Set	K152225	FDA 510(k)	Class II	Active
Edwards Lifesciences Venous Return Cannulae	K092509	FDA 510(k)	Class II	Active
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform	K231248	FDA 510(k)	Class II	Active
Flo Trac sensor, Volume View sensor	K152980	FDA 510(k)	Class II	Active
Ev1000 Clinical Platform With Clearsight Tm Finger Cuff Or Clearsight Tm System	K140312	FDA 510(k)	Class II	Active
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe	K152633	FDA 510(k)	Class II	Active
Retroflex Dilator Kit	K093554	FDA 510(k)	Class II	Active
TruWave Disposable Pressure Transducer	K142749	FDA 510(k)	Class II	Active
Edwards Peripheral Dilation Catheter	K052149	FDA 510(k)	Class II	Active
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter	K221528	FDA 510(k)	Class II	Active
Nexfin Model 2	K122381	FDA 510(k)	Class II	Active
Multi-Med Central Venous Catheters (cvcs), With And Without Heparin Vantex Central Venous Catheters (cvcs), With Heparin	K113565	FDA 510(k)	Class II	Active
EV1000 Clinical Platform	K193179	FDA 510(k)	Class II	Active
Ev1000 Platform Model: Ev1000a, Ev1000db, Ev1000m	K100709	FDA 510(k)	Class II	Active
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)	K252533	FDA 510(k)	Class II	Active
Edwards Lifesciences Percutaneous Sheath Introducers With Oligon Material	K014052	FDA 510(k)	Class II	Active
Carpentier-Edwards Physio Annuloplasty Ring (4450)	K251688	FDA 510(k)	Class II	Active
Edwards Lifesciences Intraclude Intra-Aortic Catheter	K132175	FDA 510(k)	Class II	Active
IntraClude Intra-Aortic Occlusion Device	K163693	FDA 510(k)	Class II	Active
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform	K203224	FDA 510(k)	Class II	Active
Edwards Lifesciences Thruport Knotting System	K141206	FDA 510(k)	Class II	Active
Presep And Pediasat Oximetry Catheters And Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor	K053609	FDA 510(k)	Class II	Active
Edwards MC3 Tricuspid annuloplasty ring (4900)	K251982	FDA 510(k)	Class II	Active
Fogarty Thru-Lumen Embolectomy Catheter	K240078	FDA 510(k)	Class II	Active
Embol-X Access Device/ Aortic Cannula, Embol-X Slim Accessdevice/ Aortic Cannula, Embol-X Glide Access Device/ Aortic Ca	K102420	FDA 510(k)	Class II	Active

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 31, 2015	Z-2776-2015	—	terminated	Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Edwards Lifesciences Guadalupe Cartago · CR FEI 3015287573
Edwards Lifesciences LTD Shannon Clare · IE FEI 3015179394