BEUDAMED
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    AVEERA MEDICAL

    FDA registration
    AVEERA MEDICAL·1 product·🇺🇸 United States

    Boomerang

    FDA UDI
    Aveera Medical Inc.·00860013182311·The Boomerang Push Valvulotome is an over-the-w...

    Boomerang

    FDA UDI
    Aveera Medical Inc.·00860013182304·The Boomerang Valvulotome is an over-the-wire (...

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·February 24, 2015

    Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·December 19, 2017

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2

    FDA Recall
    Open, Classified ·Getinge Usa Sales Inc·Product code FQO·October 3, 2024

    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DVBB1D1); f. Evera XT VR ICD DF4 (Product No. DVBB1D4); EXPANSION: g. Evera S DR ICD DF4 (Product No. DDBC3D4); h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); i. Evera XT DR ICD DF4 (Product No. DDBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·December 19, 2017