Edwards Lifesciences
FDA 510(k) & PMA Approved Devices — 17 products
Total Devices17
Categories9
Latest FDA decision2026-06-26
SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-04). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K254232 | 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) | PZX | 2026-06-26 | View |
| 510(k) | K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | DXC | 2026-06-05 | View |
| 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) | K200258 | Edwards eSheath Introducer Set | DYB | 2020-03-09 | View |
| 510(k) | K153069 | Edwards Balloon Catheter | OMZ | 2016-01-07 | View |
No matching devices.
Related Clinical Trials
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