BEUDAMED
    172 results · 13ms · Sources: EU EUDAMED, US FDA

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    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4

    FDA Enforcement
    Class II ·Ongoing·Medtronic, Inc.·December 10, 2025

    Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·April 7, 2021

    ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 30, 2023

    EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·August 30, 2023

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·August 17, 2022

    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·August 17, 2022

    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·August 17, 2022

    ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023

    ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023