BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ENDOPATH ULTRA VERESS NEEDLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARIES MELDICAL MODEL 2100HC HANK CRANK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UROIMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DELTA CER FM HD 036/+4MM 12/14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·January 17, 2019

    LIGASURE PRECISE

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 24, 2014

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013

    COGNIS

    FDA Adverse Event
    Death ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·February 10, 2011

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017