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Edwards Lifesciences LLC

Last updated September 17, 2026

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 36 of 36

Device	Model / Reference	Registries	Class	Status
Edwards Peripheral Dilatation Catheter	K032587	FDA 510(k)	Class II	Active
Wireless Physiologic Monitoring System	K053016	FDA 510(k)	Class II	Active
Lifestent Nt35 Biliary Stent System	K042985	FDA 510(k)	Class II	Active
Venous Drainage Cannula With Duraflo Coating	K120072	FDA 510(k)	Class II	Active
Edwards Transfemoral Balloon Catheter	K140241	FDA 510(k)	Class II	Active
Vigilance Ii Continuous Cardiac Output/Oximetry/Volumetric Monitor, Model Vig2	K043103	FDA 510(k)	Class II	Active
TruWave Disposable Pressure Transducer	K183413	FDA 510(k)	Class II	Active
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)	K242451	FDA 510(k)	Class II	Active
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	K223865	FDA 510(k)	Class II	Active
Modification To Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor	K082308	FDA 510(k)	Class II	Active
Global Hypoperfusion Index (GHI) Algorithm	K231038	FDA 510(k)	Class II	Active
Duromedics Bileaflet Heart Valve	P850006	FDA PMA	Class III	Active
Model 9310 Lung Water Computer	P800003	FDA PMA	Class III	Active
Starr Edwards Silastic Ball Prosthesis Models 1260 & 6120	P870038	FDA PMA	Class III	Active
Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm)	P250019	FDA PMA	Class III	Active
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System	P200015	FDA PMA	Unclassified	Active
EDWARDS INTUITY ELITE Valve System	P150036	FDA PMA	Class III	Active
Carpentier-Edwards S.a.v. Porcine Bioprosthesis	P010041	FDA PMA	Class III	Active
Edwards Sapien Transcatheter Heart Valve And Transapical And Transfemoral Accessories	P110021	FDA PMA	Class III	Active
Edwards Prima Plus Stentless Bioprosthesis Model 2500p	P000007	FDA PMA	Class III	Active
Carpentier-Edwards Bioprosthesis	P870056	FDA PMA	Class III	Active
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis	P870077	FDA PMA	Class III	Active
Edwards Sapien Transcatheter Heart Valve	P100041	FDA PMA	Class III	Active
EVOQUE Tricuspid Valve Replacement System	P230013	FDA PMA	Class III	Active
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON	P150048	FDA PMA	Class III	Active
Perimount Pericardial Bioprosthesis Models 2700, 2700tfx, 2800, 2800tfx, 3000, 3000tfx, 6900p Perimount Plus And 6900ptfx	P860057	FDA PMA	Class III	Active
PASCAL Precision Transcatheter Valve Repair System	P220003	FDA PMA	Class III	Active
SAPIEN XT Transcatheter Heart Valve	P130009	FDA PMA	Class III	Active
SAPIEN 3 Transcatheter Heart Valve	P140031	FDA PMA	Class III	Active

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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