Is this your brand? Sign in to claim ownership.

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 32 of 36

Device	Model / Reference	Registries	Class	Status
Truwave, Vamp Plus	T430023B	FDA UDI	Class II	Active
Flotrac, Truwave	MHD8C503	FDA UDI	Class II	Active
Truwave, Vamp Plus	PXVP2X2AT3	FDA UDI	Class II	Active
Truwave, Vamp Plus	T001691M	FDA UDI	Class II	Active
Truwave, Vamp	PXVK064	FDA UDI	Class II	Active
Edwards Prima Plus Stentless Bioprosthesis - Aortic	2500P	FDA UDI	Class III	Active
SAPIEN 3 Ultra Delivery System	9630TF26	FDA UDI	Class III	Active
Truwave, Vamp	PXVK0458	FDA UDI	Class II	Active
Fogarty Softjaw	DSOFT86	FDA UDI	Class II	Active
Edwards Lifesciences Porous Vent Plug	VP025	FDA UDI	Class II	Active
Swan-Ganz True Size	096F6	FDA UDI	Class II	Active
Vamp Jr.	VJ0990	FDA UDI	Class II	Active
Edwards Sapien Transcatheter Heart Valve (thv)	9000TFX	FDA UDI	Class III	Active
Truwave, Vamp	PXVK0789	FDA UDI	Class II	Active
Truwave X 2 (3 Cc) /vamp 88 In (225 Cm)	T434501B	FDA UDI	Class II	Active
Carpentier-Edwards Perimount Plus Pericardial Bioprosthesis - Mitral	6900P	FDA UDI	Class III	Active
Fogarty Softjaw	SOFT33	FDA UDI	Class II	Active
Carpentier-Edwards Perimount Rsrpericardial Bioprosthesis - Aortic	2800	FDA UDI	Class III	Active
CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis	2700TFX	FDA UDI	Class III	Active
ThruPort Systems Embol-X Introducer Sheath	EXIS	FDA UDI	Class II	Active
23mm X 3cm X 105cm Novaflex+ Delivery System	9355FS23	FDA UDI	Class III	Active
Fogarty Softjaw	HCDSOFT8	FDA UDI	Class II	Active
Truwave, Vamp	PXVK1099	FDA UDI	Class II	Active
Carpentier-Edwards Perimount Pericardial Bioprosthesis - Aortic	2700	FDA UDI	Class III	Active
Truwave, Vamp	PXVK0802	FDA UDI	Class II	Active
Thin-Flex Dual Stage Venous Drainage Cannula	TF2937OA	FDA UDI	Class II	Active
Truwave, Vamp Plus	PXVP0843	FDA UDI	Class II	Active
SAPIEN 3 Ultra RESILIA	9755RSL20	FDA UDI	Class III	Active
EMBOL-X Intra-Aortic Filter with Duraflo Coating	EXLLD	FDA UDI	Class II	Active
Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis - Aortic	3000	FDA UDI	Class III	Active
Cosgrove-Edwards Annuloplasty Band With Template/Lanyard	4600	FDA UDI	Class II	Active
Fogarty Safejaw	CSAFE6	FDA UDI	Class II	Active
Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis - Aortic	2700TFX	FDA UDI	Class III	Active
Co-Set+	93529	FDA UDI	Class II	Active
Truwave, Vamp	T005048B	FDA UDI	Class II	Active
Fogarty Safejaw	SAFE61	FDA UDI	Class II	Active
AViD Dual Stage Venous Drainage Cannula	TF292901	FDA UDI	Class II	Active
Edwards Lifesciences Dual Stage Venous Drainage Cannula	TR3446L	FDA UDI	Class II	Active
Truwave, Vamp Plus	PXVP0778	FDA UDI	Class II	Active
FloTrac IQ, VAMP Optima	MHDQ8VZ	FDA UDI	Class II	Active
Swan-Ganz Controlcath True Size	C145F6N	FDA UDI	Class II	Active
Thin-Flex Single Stage Malleable Venous Drainage Cannula	TFM032L	FDA UDI	Class II	Unknown
Thin-Flex Dual Stage Venous Drainage Cannula	TF2937O	FDA UDI	Class II	Active
Edwards Lifesciences Dual Stage Venous Drainage Cannula	TR3651B	FDA UDI	Class II	Active
The Edwards Sapien 3 Valve With Alterra Adaptive Prestent System	29AP4045	FDA UDI	Unclassified	Active
Truwave /vamp Jr	T430169A	FDA UDI	Class II	Active
Trim-Flex Dual Stage Venous Drainage Cannula	TRF3646OA	FDA UDI	Class II	Active
Truwave, Vamp	PXVK0364	FDA UDI	Class II	Active
Carpentier-Edwards Perimount Rsrpericardial Bioprosthesis - Aortic	2800	FDA UDI	Class III	Active
Port Access Systems Endodirect Arterial Cannula Model Ed24 (old Code Was-Dfk24)	K093730	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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