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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 34 of 36

Device	Model / Reference	Registries	Class	Status
Ew200 System (oxygen Saturation Monitoring System) And Presep Oximetry Catheter	K060660	FDA 510(k)	Class II	Active
Edwards Lifesciences Lifestent Nt18 Self-Expanding Biliary Stent And Delivery System	K024303	FDA 510(k)	Class II	Active
Ascendra Balloon Aortic Valvaloplasty Catheter	K142199	FDA 510(k)	Class II	Active
VAMP Plus Venous/Arterial Blood Management Protection System	K181684	FDA 510(k)	Class II	Active
Physio Flex Annuloplasty Ring	K192762	FDA 510(k)	Class II	Active
EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B);	K233895	FDA 510(k)	Class II	Active
Edwards Mc Tricuspid Annuloplasty System, Model 4900	K020864	FDA 510(k)	Class II	Active
FusedCO Algorithm	K231035	FDA 510(k)	Class II	Active
Retroflex 3 Introducer Sheath Set, Models 9120s23 And 9120s26	K093877	FDA 510(k)	Class II	Active
Edward Proplege Peripheral Retrograde Cardioplegia Device	K120780	FDA 510(k)	Class II	Active
Edwards Directional Catheter	K030630	FDA 510(k)	Class II	Active
Ev1000 Clinical Platform	K131892	FDA 510(k)	Class II	Active
The ClearSight finger cuffs	K190130	FDA 510(k)	Class II	Active
Fogarty Occlusion Catheter	K211610	FDA 510(k)	Class II	Active
Edwards Balloon Catheter	K153069	FDA 510(k)	Class II	Active
Fogarty Venous Thrombectomy Catheters	K233819	FDA 510(k)	Class II	Active
Lifestitch Suturing Device	K013990	FDA 510(k)	Class II	Active
Ev1000 Clinical Platform	K110597	FDA 510(k)	Class II	Active
HemoSphere Nano Monitor (HSNANO1)	K253186	FDA 510(k)	Class II	Active
Presep Oligon Oximetry Catheters	K060093	FDA 510(k)	Class II	Active
Edwards Esheath Introducer Set	K141696	FDA 510(k)	Class II	Active
Acumen Hypotension Prediction Index (HPI) Algorithm	K230057	FDA 510(k)	Class II	Active
Edwards E360 Surgical Ablation Device	K041739	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module	K190205	FDA 510(k)	Class II	Active
Lifestent Turbo Biliary Stent Systems	K050627	FDA 510(k)	Class II	Active
Geoform Annuloplasty Ring, Mitral Model 4200	K032250	FDA 510(k)	Class II	Active
Duravess bovine pericardial vascular patch	K172660	FDA 510(k)	Class II	Active
EV1000 Clinical Platform NI, EV1000 Clinical Platform	K192058	FDA 510(k)	Class II	Active
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform	K203131	FDA 510(k)	Class II	Active
Edwards Introducer Sheath	K031087	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable	K223127	FDA 510(k)	Class II	Active
TruWave Disposable Pressure Transducer	K171996	FDA 510(k)	Class II	Active
Fogarty Occlusion Catheter	K093911	FDA 510(k)	Class II	Active
Carpentier- Edwards Physio Ii Annuloplasty, Model 5200	K083470	FDA 510(k)	Class II	Active
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe	K193379	FDA 510(k)	Class II	Active
Edwards Lifesciences Research Medical Pediatric Venous Return Cannulae	K033464	FDA 510(k)	Class II	Active
Ferm-Flex And Fem-Flex Ii ( Femoral Access Arterial Cannulae) Femtrak, Vfem, And Fem-Flexii	K140208	FDA 510(k)	Class II	Active
Edwards Lifesciences Intraclude Intra-Aortic Catheter	K113182	FDA 510(k)	Class II	Active
PreSep Oligon Oximetry Catheter	K160645	FDA 510(k)	Class II	Active
Vigilance Continuous Cardiac Output/Oximetry/Continuous End Diastolic Volume (cc0/Svo2/Cedv) Monitor	K040287	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor, HemoSphere ClearSight Module	K221833	FDA 510(k)	Class II	Active
Hypertension Prediction Index (HePI) Algorithm	K242518	FDA 510(k)	Class II	Active
Edwards Suture Fastening System	K150882	FDA 510(k)	Class I	Active
FORE-SIGHT ELITE Absolute Tissue Oximeter	K203490	FDA 510(k)	Class II	Active
Fogarty Fortis Arterial Embolectomy Catheter	K241330	FDA 510(k)	Class II	Active
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters	K233619	FDA 510(k)	Class II	Active
Axillary Access Arterial Cannula	K002578	FDA 510(k)	Class II	Active
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index	K203687	FDA 510(k)	Class II	Active
Presep Oligon Oximetry Catheters (16 Cm, W/Heparin), (20cm, W/Heparin)	K110167	FDA 510(k)	Class II	Active
Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; Vigileo Apco/Oximetry Monitor	K131588	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

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Authorities

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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