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Sign in to claim this brandEdwards Lifesciences LLC
US
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
- —
- —
- [email protected]
- Phone
- +1(800)822-9637
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2015691
- DUNS Number
- 134139174
Catalogue (1779)
Page 4 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acumen Iq | AIQSFM6AZ5 | FDA UDI | Class II | Active |
| Evoque | 9850TDSUS | FDA UDI | Class III | Active |
| Truwave | T440B20B | FDA UDI | Class II | Active |
| TruWave, VAMP Plus | PXVPL0111 | FDA UDI | Class II | Active |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis - Aortic | 2700 | FDA UDI | Class III | Active |
| Truwave | PXMK0666 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Edwards Lifesciences Aortic Perfusion Cannula | ARL2011SA | FDA UDI | Class II | Active |
| Truwave, Vamp | PXVMP172AT3 | FDA UDI | Class II | Active |
| Swan-Ganz Controlcath True Size | C144NX7 | FDA UDI | Class II | Active |
| Edwards Sapien Transcatheter Heart Valve (thv) | 9000TFX | FDA UDI | Class III | Unknown |
| Pediasat | XT3515SP | FDA UDI | Class II | Active |
| Fogarty | 410235F | FDA UDI | Class II | Active |
| Truwave | PXMK573 | FDA UDI | Class II | Active |
| VolumeView | VLV6R416 | FDA UDI | Class II | Active |
| Edwards Dilator Kit | 9100DKSA | FDA UDI | Class II | Active |
| Hemosphere | PSCOEM100MR | FDA UDI | Class II | Active |
| EMBOL-X Intra-Aortic Filter with Duraflo Coating | EXXLD | FDA UDI | Class II | Active |
| Ev1000 | EVECL | FDA UDI | Class II | Active |
| Truwave | T005080A | FDA UDI | Class II | Active |
| Truwave | PX604 | FDA UDI | Class II | Active |
| SAPIEN 3 Ultra RESILIA | 9755RSL23 | FDA UDI | Class III | Active |
| Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis | 7000TFX | FDA UDI | Class III | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Edwards Lifesciences Aortic Perfusion Cannula | PEDA008SB | FDA UDI | Class II | Unknown |
| Truwave | PXMK2082 | FDA UDI | Class II | Active |
| Truwave | PXMK1506 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Edwards Sapien 3 Transcatheter Heart Valve (thv) | 9600TFX | FDA UDI | Class III | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Fogarty | 12GV0402F | FDA UDI | Class II | Active |
| Truwave | PXMK1761 | FDA UDI | Class II | Active |
| Swan-Ganz | 131F7 | FDA UDI | Class II | Active |
| Acumen IQ | AIQS6C502 | FDA UDI | Class II | Active |
| Truwave, Vamp Jr | T430168A | FDA UDI | Class II | Active |
| Carpentier-Edwards Perimount Rsrpericardial Bioprosthesis - Aortic | 2800TFX | FDA UDI | Class III | Active |
| Truwave | PXMK2270 | FDA UDI | Class II | Active |
| Edwards Certitude Delivery System | 9600SDS20 | FDA UDI | Class III | Active |
| Carpentier-Edwards Bioprosthesis - Aortic | 2625 | FDA UDI | Class III | Active |
| Fem-Flex II Femoral Arterial Cannula | FEMII012A | FDA UDI | Class II | Unknown |
| Truwave | PXMK1724 | FDA UDI | Class II | Active |
| Swan-Ganz | 110F5 | FDA UDI | Class II | Active |
| Truwave | PXMK2330 | FDA UDI | Class II | Active |
| 26f (8.6mm) X 25cm Ascendra+ Introducer Sheath Set | 9350IS29 | FDA UDI | Class III | Active |
| Carpentier-Edwards Classic Annuloplasty Ring - Tricuspid | 4500T | FDA UDI | Class II | Active |
| Truwave | PXMK2143 | FDA UDI | Class II | Active |
| Truwave | PXMK2036 | FDA UDI | Class II | Active |
| Truwave | T491Y01B | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
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