Edwards Lifesciences
Edwards Lifesciences holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026.
Top product codes for Edwards Lifesciences
Recent clearances by Edwards Lifesciences
- K254232 — ECLIPTIS Left Atrial Appendage Exclusion System (4 models)
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K254279 — Edwards eSheath+ introducer set
- K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- K253034 — HemoSphere Stream Module
- K252364 — Edwards eSheath Optima introducer set
- K243781 — HemoSphere Advanced Monitor (HEM1) +9 more
- K244046 — Edwards eSheath Optima introducer set
- K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more
- K240596 — Cerebral Autoregulation Index (CAI) Algorithm
- K241330 — Fogarty Fortis Arterial Embolectomy Catheter
- K233983 — Swan-Ganz Pacing Probe and Catheters +4 more
- K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve
- K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
- K233895 — EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA) +2 more
- DEN190029 — Acumen Assisted Fluid Management (AFM) Software Feature
- K200258 — Edwards eSheath Introducer Set
- K153069 — Edwards Balloon Catheter
- K152225 — Edwards eSheath Introducer Set
- K142199 — Ascendra Balloon Aortic Valvaloplasty Catheter
- K141696 — EDWARDS ESHEATH INTRODUCER SET
- K110597 — EV1000 CLINICAL PLATFORM
Data sourced from openFDA. This site is unofficial and independent of the FDA.