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Edwards Lifesciences

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories8
Latest Approval2026-04-17
TypeNumberDevice NameCodeDate
510(k) K254279 Edwards eSheath+ introducer set DYB 2026-04-17 View
510(k) K252533 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) DQK 2025-12-18 View
510(k) K253034 HemoSphere Stream Module DQK 2025-10-21 View
510(k) K252364 Edwards eSheath Optima introducer set DYB 2025-08-29 View
510(k) K243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) DQK 2025-07-23 View
510(k) K244046 Edwards eSheath Optima introducer set DYB 2025-03-27 View
510(k) K242451 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) DYG 2024-12-09 View
510(k) K240596 Cerebral Autoregulation Index (CAI) Algorithm MUD 2024-10-16 View
510(k) K241330 Fogarty Fortis Arterial Embolectomy Catheter DXE 2024-07-02 View
510(k) K233983 Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) DYG 2024-06-27 View
510(k) K233820 Fogarty Arterial Embolectomy Catheter with Gate Valve DXE 2024-05-22 View
510(k) K233619 Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters DXE 2024-05-20 View
510(k) K233895 EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); DWF 2024-02-05 View
510(k) DEN190029 Acumen Assisted Fluid Management (AFM) Software Feature QMS 2020-11-13 View
510(k) K200258 Edwards eSheath Introducer Set DYB 2020-03-09 View
510(k) K153069 Edwards Balloon Catheter OMZ 2016-01-07 View
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