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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 1 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vamp | VMP400 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| FloTrac IQ sensor | MHDQ6AZ5 | FDA UDI | Class II | Active |
| Edwards Lifesciences Aortic Perfusion Cannula | PAA016CB | FDA UDI | Class II | Unknown |
| Co-Set+ | 93522 | FDA UDI | Class II | Active |
| Acumen Iq Sensor For Afm | AIQSAFM8R5 | FDA UDI | Class II | Active |
| Truwave | T320564A | FDA UDI | Class II | Active |
| Edwards Lifesciences Retrograde Cardioplegia Catheter | RC2012 | FDA UDI | Class II | Active |
| Fem-Flex II Femoral Arterial Cannula | FEMII014AT | FDA UDI | Class II | Active |
| Truwave X 2 (3 Cc) /vamp 86 In (220 Cm) | T430180A | FDA UDI | Class II | Active |
| Truwave | PXAK1568 | FDA UDI | Class II | Active |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis - Aortic | 2700 | FDA UDI | Class III | Active |
| Swan-Ganz True Size | 123F6 | FDA UDI | Class II | Active |
| Truwave | PXMK2277 | FDA UDI | Class II | Active |
| Fogarty | 410236F | FDA UDI | Class II | Active |
| Truwave | PXMK142 | FDA UDI | Class II | Active |
| Truwave | PXMK1545 | FDA UDI | Class II | Active |
| 23 Mm X 3cm X 110cm Retroflex Delivery System | 9120FS23 | FDA UDI | Class III | Active |
| Ev1000 | EVEC12FT | FDA UDI | Class II | Active |
| Edwards Lifesciences Femoral Venous Cannula | VFEM024 | FDA UDI | Class II | Active |
| Edwards Lifesciences EZ Glide Aortic Cannula with Quick Venting Cap | EZS21QTA | FDA UDI | Class II | Active |
| Truwave | PXAK1022 | FDA UDI | Class II | Active |
| Truwave | VLMF120R | FDA UDI | Class II | Active |
| Truwave | 55UF130 | FDA UDI | Class II | Active |
| Edwards Certitude Delivery System | 9600SDS23 | FDA UDI | Class III | Active |
| Truwave | 50P236 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Fem-Flex Femoral Arterial Cannula | TFA02425 | FDA UDI | Class II | Active |
| AViD Dual Stage Venous Drainage Cannula | TF292902 | FDA UDI | Class II | Active |
| Edwards Lifesciences Retrograde Cardioplegia Catheter | RC2014M | FDA UDI | Class II | Active |
| Carpentier-Edwards Classic Annuloplasty Ring - Mitral | 4400 | FDA UDI | Class II | Active |
| Truwave | PX1800 | FDA UDI | Class II | Active |
| Carpentier-Edwards Bioprosthesis - Mitral | 6625 | FDA UDI | Class III | Active |
| Truwave, Vamp | PXVK0363 | FDA UDI | Class II | Active |
| Truwave | 1WV12 | FDA UDI | Class II | Active |
| Combo Kit | PXAVMPL | FDA UDI | Class II | Active |
| Vamp | 48VMP106 | FDA UDI | Class II | Active |
| Truwave | PXMK2221 | FDA UDI | Class II | Active |
| Thin-Flex Single Stage Venous Drainage Cannula | VC02290 | FDA UDI | Class II | Active |
| OptiSite Arterial Perfusion Cannula | OPTI22 | FDA UDI | Class II | Active |
| Acumen Iq Sensor | AIQS8S102 | FDA UDI | Class II | Active |
| Edwards Lifesciences Vascular Torniquet Kit | TK2 | FDA UDI | Class II | Active |
| Truwave | PXMK077 | FDA UDI | Class II | Active |
| Truwave | T310682A | FDA UDI | Class II | Active |
| Thin-Flex Single Stage Venous Drainage Cannula | TF024O90 | FDA UDI | Class II | Active |
| Acumen IQ | AIQS6 | FDA UDI | Class II | Active |
| SAPIEN 3 Ultra Delivery System | 9630TF23 | FDA UDI | Class III | Active |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve | 9750TFX26 | FDA UDI | Class III | Active |
| Truwave | T450217A | FDA UDI | Class II | Active |
| Acumen IQ | AIQS65 | FDA UDI | 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