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Edwards Lifesciences

FDA 510(k) & PMA Approved Dispositivos — 17 products

Total de dispositivos17
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
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)PZX2026-06-26 Ver
510(k) K260105 Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC2026-06-05 Ver
510(k) K254279 Edwards eSheath+ introducer setDYB2026-04-17 Ver
510(k) K252533 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK2025-12-18 Ver
510(k) K253034 HemoSphere Stream ModuleDQK2025-10-21 Ver
510(k) K252364 Edwards eSheath Optima introducer setDYB2025-08-29 Ver
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)DQK2025-07-23 Ver
510(k) K244046 Edwards eSheath Optima introducer setDYB2025-03-27 Ver
510(k) K242451 HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)DYG2024-12-09 Ver
510(k) K240596 Algoritmo de Índice de Autoregulação Cerebral (CAI)MUD2024-10-16 Ver
510(k) K241330 Fogarty Fortis Arterial Embolectomy CatheterDXE2024-07-02 Ver
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)DYG2024-06-27 Ver
510(k) K233820 Fogarty Arterial Embolectomy Catheter with Gate ValveDXE2024-05-22 Ver
510(k) K233619 Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE2024-05-20 Ver
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);DWF2024-02-05 Ver
510(k) K200258 Edwards eSheath Introducer SetDYB2020-03-09 Ver
510(k) K153069 Edwards Balloon CatheterOMZ2016-01-07 Ver
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