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Edwards Lifesciences, LLC

FDA 510(k) & PMA Approved Devices — 64 products

Total Devices64
Categories27
Latest FDA decision2026-08-05
TypeNumberDevice NameCodeDateActions
PMA P230013 Percutaneously Delivered Prostheses and Tricuspid ValvesNPW2026-08-05 View
PMA P140031 Aortic valve, prosthesis, percutaneously deliveredNPT2026-07-29 View
PMA P860057 replacement Heart-valveDYE2026-07-29 View
PMA P150036 heart-valve, non-allograft tissueLWR2026-07-29 View
PMA P150048 heart-valve, non-allograft tissueLWR2026-07-29 View
PMA P200015 Pulmonary valve prosthesis percutaneously deliveredNPV2026-07-29 View
PMA P220003 Mitral valve repair devicesNKM2026-07-29 View
PMA P250019 Prosthesis, mitral valve, percutaneously deliveredNPU2026-07-29 View
510(k) K251326 Respiration Rate algorithmBZQ2026-06-11 View
510(k) K253186 HemoSphere Nano Monitor (HSNANO1)DQK2026-02-24 View
510(k) K251982 Edwards MC3 Tricuspid annuloplasty ring (4900)KRH2025-09-23 View
510(k) K251688 Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH2025-09-17 View
510(k) K242518 Hypertension Prediction Index (HePI) AlgorithmQAQ2025-05-15 View
510(k) K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS2025-03-21 View
510(k) K240078 Fogarty Thru-Lumen Embolectomy CatheterDXE2024-08-28 View
510(k) K233984 Acumen Assisted Fluid Management (AFM) Software FeatureQMS2024-08-02 View
510(k) K233824 Swan-Ganz catheterDYG2024-06-06 View
510(k) K233819 Fogarty Venous Thrombectomy CathetersDXE2024-05-22 View
510(k) K230612 Edwards Algorithm for Measurement of Blood HemoglobinMUD2023-11-17 View
510(k) K232294 HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)DQK2023-10-31 View

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Related Clinical Trials

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITINGNCT04430075MiCLASP Post Market Clinical Follow-Up (PMCF) StudyACTIVE_NOT_RECRUITINGNCT04614402Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair SystemACTIVE_NOT_RECRUITINGNCT04919980TVMR With the INNOVALVE System Trial - Early Feasibility StudyRECRUITINGNCT05006404Autus Valve Pivotal StudyACTIVE_NOT_RECRUITING
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