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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 33 of 36

Device	Model / Reference	Registries	Class	Status
Edwards Lifesciences Vantex Central Venous Catheters With Thermistor	K033250	FDA 510(k)	Class II	Active
Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring, Model 4100	K083623	FDA 510(k)	Class II	Active
Catheter Introducer Sheath	K131627	FDA 510(k)	Class II	Active
VAMP Venous/Arterial Blood Management Protection System	K173586	FDA 510(k)	Class II	Active
Edwards Algorithm for Measurement of Blood Hemoglobin	K230612	FDA 510(k)	Class II	Active
Lifestent Flexstar Xl Biliary Stent System	K060487	FDA 510(k)	Class II	Active
Femoral Access Venous Cannulae	K123303	FDA 510(k)	Class II	Active
Modification To: Lifestent Valeo Biliary Stent System	K052132	FDA 510(k)	Class II	Active
Swan-Ganz catheter	K233824	FDA 510(k)	Class II	Active
HemoSphere Stream Module	K253034	FDA 510(k)	Class II	Active
Edwards eSheath+ introducer set	K254279	FDA 510(k)	Class II	Active
Acumen IQ finger cuff	K230919	FDA 510(k)	Class II	Active
Edwards eSheath Introducer Set	K162184	FDA 510(k)	Class II	Active
Multi-Med Central Venous Catheters, Models: M3720hkic, M4820hkic	K091709	FDA 510(k)	Class II	Active
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform	K160552	FDA 510(k)	Class II	Active
Edward Vent Catheters Edward Vent Catheters With Duraflo Coating Dispersion Aortic Perfusion Cannula	K113411	FDA 510(k)	Class II	Active
Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor, Models Mihm1 And Mihm1p	K043065	FDA 510(k)	Class II	Active
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System	K182245	FDA 510(k)	Class II	Active
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	K213682	FDA 510(k)	Class II	Active
Fogarty Occlusion Catheter	K152762	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor, HemoSphere Pressure Cable	K180881	FDA 510(k)	Class II	Active
Swan Ganz Catheters	K160084	FDA 510(k)	Class II	Active
Cerebral Adaptive Index (CAI) Algorithm	K223651	FDA 510(k)	Class II	Active
Edwards Lifesciences Left Atrial Pressure Monitor Catheter	K110103	FDA 510(k)	Class II	Active
VAMP Optima closed blood sampling system	K180275	FDA 510(k)	Class II	Active
Edwards Lifesciences Research Medical Pediatric Arterial Cannulae	K033463	FDA 510(k)	Class II	Active
Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)	K233983	FDA 510(k)	Class II	Active
Cardioplegia Delivery Sets Cardioplegia Delivery Sets With Duraflo Coating	K113667	FDA 510(k)	Class II	Active
Edwards Bovine Pericardial Patch, Model 4700	K082139	FDA 510(k)	Class II	Active
Edwards eSheath Introducer Set	K200258	FDA 510(k)	Class II	Active
HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)	K232294	FDA 510(k)	Class II	Active
Edwards Embol-X Introducer Sheath	K123714	FDA 510(k)	Class II	Active
Embol-X Introducer Sheath	K140398	FDA 510(k)	Class II	Active
Lifestent Flexstart Biliary Stent System	K053404	FDA 510(k)	Class II	Active
Steerable Retrograde Cardioplegia Cannula With And Without Duraflo Treatment, Models Srco14mib, Diisrco14mib	K001565	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)	K221704	FDA 510(k)	Class II	Active
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure	K183646	FDA 510(k)	Class II	Active
Ez Glide Aortic Cannula, Aortic Perfusion Cannula With Duraflo Coating, Dispersion Aortic Perfusion Cannula	K123370	FDA 510(k)	Class II	Active
Edwards Lifesciences Endoclamp Aortic Catheter	K112694	FDA 510(k)	Class II	Active
Edwards eSheath Optima introducer set	K252364	FDA 510(k)	Class II	Active
Acumen Hypotension Prediction Index (HPI) Feature Software	DEN160044	FDA 510(k)	Class II	Active
Smart Wedge algorithm	K230579	FDA 510(k)	Class II	Active
Cerebral Autoregulation Index (CAI) Algorithm	K240596	FDA 510(k)	Class II	Active
VAMP Venous/Arterial Blood Management Protection System	K161962	FDA 510(k)	Class II	Active
Anteplegia Catheter Antegrade Cardioplegia Catheter Aortic Root Cannula Antegrade Catheter With Duraflo Coating	K113459	FDA 510(k)	Class II	Active
Edwards Lifesciences Percutaneous Sheath Introducers With Oligon Material	K030944	FDA 510(k)	Class II	Active
Fem-Felx, Fex-Flex Ii Femoral Access Cannula With Duraflo Coating	K123298	FDA 510(k)	Class II	Active
Edwards Lifesciences Swan-Ganz Monitoring Catheter With Oligon Material	K014054	FDA 510(k)	Class II	Active
Fogarty Valvulotome, Model 700091	K001734	FDA 510(k)	Class II	Active
Edwards eSheath Optima introducer set	K244046	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