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Sign in to claim this brandEdwards Lifesciences LLC
US
Last updated September 17, 2026
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 2 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Swan-Ganz Controlcath True Size | S144F7 | FDA UDI | Class II | Active |
| Truwave | PXMK2122 | FDA UDI | Class II | Active |
| Truwave | T461803B | FDA UDI | Class II | Active |
| Vamp | 48VMPL284 | FDA UDI | Class II | Active |
| Acumen Iq Sensor | AIQS8S | FDA UDI | Class II | Active |
| HemoSphere Vita | HEMPC2K | FDA UDI | Class II | Active |
| Cosgrove-Edwards Annuloplasty Band With Template/Lanyard | 4600 | FDA UDI | Class II | Active |
| Trim-Flex Dual Stage Venous Drainage Cannula | TRF3646O2 | FDA UDI | Class II | Active |
| Foresight Elite | FSEO2004 | FDA UDI | Class II | Active |
| Truwave, Vamp Plus | PXVP0902 | FDA UDI | Class II | Active |
| PX1800 – Truwave Cables | 896140024 | FDA UDI | Class II | Active |
| Truwave | T531401A | FDA UDI | Class II | Active |
| Edwards Lifesciences Arterial Perfusion Cannula | APC022B | FDA UDI | Class II | Unknown |
| Carpentier-Mccarthy-Adams Imr Etlogix Annuloplasty Ring With Holder | 4100 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Edwards Mc3 Tricuspid Annuloplasty Ring | 4900T | FDA UDI | Class II | Active |
| Truwave, Vamp | PXVK2W4IV | FDA UDI | Class II | Active |
| Truwave | PX36N | FDA UDI | Class II | Active |
| Carpentier-Edwards Perimount Rsrpericardial Bioprosthesis - Aortic | 2800TFX | FDA UDI | Class III | Active |
| TruWave | MP111 | FDA UDI | Class I | Active |
| Truwave/Vamp | T431305A | FDA UDI | Class II | Active |
| Thin-Flex Single Stage Malleable Venous Drainage Cannula | TFM028L | FDA UDI | Class II | Unknown |
| CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis | 2700TFX | FDA UDI | Class III | Active |
| Edwards Lifesciences Retrograde Cardioplegia Catheter | RC014MIB | FDA UDI | Class II | Active |
| Truwave | PXMK1071 | FDA UDI | Class II | Active |
| PX1800 – Truwave Cables | 896004025 | FDA UDI | Class II | Active |
| Edwards Lifesciences Retrograde Cardioplegia Catheter | SRT014MIBB | FDA UDI | Class II | Active |
| Truwave | PXMK2064 | FDA UDI | Class II | Active |
| Edwards Mc3 Tricuspid Annuloplasty Ring | 4900T | FDA UDI | Class II | Active |
| Truwave | PX4X4 | FDA UDI | Class II | Active |
| Edwards Mc3 Tricuspid Annuloplasty Ring | 4900T | FDA UDI | Class II | Active |
| FloTrac, VAMP Optima | MHD8VRL5 | FDA UDI | Class II | Active |
| Carpentier-Edwards S.a.vbioprosthesis - Aortic | 2650 | FDA UDI | Class III | Active |
| Edwards Lifesciences Retrograde Cardioplegia Catheter | ISP3073 | FDA UDI | Class II | Active |
| Edwards Lifesciences Vent Catheter | E060 | FDA UDI | Class II | Active |
| Edwards Lifesciences EZ Glide Aortic Cannula | EZS21TA | FDA UDI | Class II | Active |
| Truwave, Vamp | PXVMP2X21 | FDA UDI | Class II | Active |
| Fogarty | 120403FSP | FDA UDI | Class II | Active |
| Edwards Prima Plus Stentless Bioprosthesis - Aortic | 2500P | FDA UDI | Class III | Active |
| Edwards Commander Delivery System | 9600LDS29 | FDA UDI | Class III | Active |
| Truwave | T325202A | FDA UDI | Class II | Active |
| Edwards Lifesciences EZ Glide Aortic Cannula | EZS24A | FDA UDI | Class II | Active |
| Thin-Flex Single Stage Venous Drainage Cannula | TF038L | FDA UDI | Class II | Active |
| Truwave | T433201A | FDA UDI | Class II | Active |
| Vamp | 48VMP184 | FDA UDI | Class II | Active |
| Truwave | 593WSC | FDA UDI | Class II | Active |
| Truwave | T001624A | FDA UDI | Class II | Active |
| Edwards Lifesciences Aortic Perfusion Cannula | ARL2011STA | FDA UDI | Class II | Active |
| FloTrac IQ | MHDQ8 | FDA UDI | Class II | Active |
| Carpentier-Edwards Bioprosthesis - Aortic | 2625 | FDA UDI | Class III | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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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