BEUDAMED
    101 results · 39ms · Sources: EU EUDAMED, US FDA

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    Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.

    FDA Enforcement
    Class II ·Terminated·Cardiogenesis Corporation·September 18, 2013

    Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.

    FDA Recall
    Terminated ·Cardiogenesis Corporation·Product code MNO·May 1, 2011

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·August 21, 2012

    SOLOGRIP III

    FDA Adverse Event
    CARDIOGENESIS CORPORATION·Product code MNO·August 20, 2012

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Death ·CARDIOGENESIS CORPORATION·Product code MNO·January 17, 2012

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    CARDIOGENESIS CORPORATION·Product code MNO·January 17, 2012

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·April 8, 2014

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·April 24, 2014

    SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·April 28, 2014

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·May 2, 2014

    SOLARGEN 2100S TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·October 3, 2014

    TMR 2000 TRANSMYOCARDIAL REVASCULARIZATION LASER CONSOLE

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·December 22, 2014

    SOLARGEN 2100S TRANSYMOCARDIAL REVASCULARIZATION LASER CONSOLE

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·December 22, 2014

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·November 19, 2014

    SOLOGRIP III

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·May 3, 2012

    SOLOGRIP III

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·March 16, 2012

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·March 5, 2013

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Malfunction ·CARDIOGENESIS CORPORATION·Product code MNO·June 12, 2013

    SOLOGRIP III HANDPIECE

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·January 6, 2014

    SOLOGRIP III

    FDA Adverse Event
    Injury ·CARDIOGENESIS CORPORATION·Product code MNO·March 26, 2014