BEUDAMED
    41 results · 22ms · Sources: EU EUDAMED, US FDA

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    MRI EVOlution 24

    Device
    EU MDR · Eu Md Class 2a ·Esaote S.p.A.·On the market·32 countries

    E-MRI EVO Viewer

    Device
    EU MDR · Eu Md Class 2a ·Esaote S.p.A.·On the market·32 countries

    E-MRI Brio Viewer

    Device
    EU MDD · Eu Md Class 1 ·Esaote S.p.A.·On the market·32 countries

    E-MRI Brio Viewer eXP

    Device
    EU MDD · Eu Md Class 2a ·Esaote S.p.A.·On the market·32 countries

    MRI Dynamic Analysis Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T

    Device
    EU MDR · Eu Md Class 2a ·ASG Superconductors S.p.A.·On the market·3 countries

    E-MRI Brio Viewer

    Basic UDI-DI
    EU MDD · Eu Md Class 1 ·Esaote S.p.A.·1 device

    E-MRI Brio Viewer eXP

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Esaote S.p.A.·1 device

    MRI system, accessory Risk Class I

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Esaote S.p.A.·11 devices

    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Enforcement
    Class II ·Terminated·Sorin Group Italia SRL - CRF·October 4, 2017

    Aries srl

    Manufacturer
    🇮🇹 Italy·1 Basic UDI-DI·1 Device·TUV Rheinland Italia SRL

    MEASUREMENT DEVICES - OTHER

    Device
    EU MDD · Eu Md Class 1 ·Aries srl·On the market

    xgenus Aries

    Device
    EU MDR · Eu Md Class 2b ·de Götzen S.r.l.·On the market·32 countries

    xgenus Aries

    Device
    EU MDR · Eu Md Class 2b ·de Götzen S.r.l.·On the market·32 countries

    xgenus Aries

    Device
    EU MDR · Eu Md Class 2b ·de Götzen S.r.l.·On the market·32 countries