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Edwards Lifesciences FDA Approvals
0 new drug approvals and 15 device clearances on file. Matched by name to EW.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)510(k)Jun 26, 2026General, Plastic Surgery |
| Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts510(k)Jun 5, 2026Cardiovascular |
| Edwards eSheath+ introducer set510(k)Apr 17, 2026Cardiovascular |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)510(k)Dec 18, 2025Cardiovascular |
| HemoSphere Stream Module510(k)Oct 21, 2025Cardiovascular |
| Edwards eSheath Optima introducer set510(k)Aug 29, 2025Cardiovascular |
| 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)510(k)Jul 23, 2025Cardiovascular |
| Edwards eSheath Optima introducer set510(k)Mar 27, 2025Cardiovascular |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)510(k)Dec 9, 2024Cardiovascular |
| Cerebral Autoregulation Index (CAI) Algorithm510(k)Oct 16, 2024Cardiovascular |
| Fogarty Fortis Arterial Embolectomy Catheter510(k)Jul 2, 2024Cardiovascular |
| 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)510(k)Jun 27, 2024Cardiovascular |
| Fogarty Arterial Embolectomy Catheter with Gate Valve510(k)May 22, 2024Cardiovascular |
| Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters510(k)May 20, 2024Cardiovascular |
| 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);510(k)Feb 5, 2024Cardiovascular |