| 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) (K254232) | Edwards Lifesciences | 2026-06-26 |
| Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105) | Edwards Lifesciences | 2026-06-05 |
| Edwards eSheath+ introducer set (K254279) | Edwards Lifesciences | 2026-04-17 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (K252533) | Edwards Lifesciences | 2025-12-18 |
| HemoSphere Stream Module (K253034) | Edwards Lifesciences | 2025-10-21 |
| Edwards eSheath Optima introducer set (K252364) | Edwards Lifesciences | 2025-08-29 |
| 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) (K243781) | Edwards Lifesciences | 2025-07-23 |
| Edwards eSheath Optima introducer set (K244046) | Edwards Lifesciences | 2025-03-27 |
| HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (K242451) | Edwards Lifesciences | 2024-12-09 |
| Cerebral Autoregulation Index (CAI) Algorithm (K240596) | Edwards Lifesciences | 2024-10-16 |
| Fogarty Fortis Arterial Embolectomy Catheter (K241330) | Edwards Lifesciences | 2024-07-02 |
| 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) (K233983) | Edwards Lifesciences | 2024-06-27 |
| Fogarty Arterial Embolectomy Catheter with Gate Valve (K233820) | Edwards Lifesciences | 2024-05-22 |
| Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (K233619) | Edwards Lifesciences | 2024-05-20 |
| 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); (K233895) | Edwards Lifesciences | 2024-02-05 |
| Acumen Assisted Fluid Management (AFM) Software Feature (DEN190029) | Edwards Lifesciences | 2020-11-13 |
| Edwards eSheath Introducer Set (K200258) | Edwards Lifesciences | 2020-03-09 |
| Edwards Balloon Catheter (K153069) | Edwards Lifesciences | 2016-01-07 |
| Edwards eSheath Introducer Set (K152225) | Edwards Lifesciences | 2015-11-24 |
| Ascendra Balloon Aortic Valvaloplasty Catheter (K142199) | Edwards Lifesciences | 2014-10-29 |
| EDWARDS ESHEATH INTRODUCER SET (K141696) | Edwards Lifesciences | 2014-09-18 |
| EV1000 CLINICAL PLATFORM (K110597) | Edwards Lifesciences | 2011-06-14 |