BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SAKURA DRS-60 AUTOMATIC SLIDE STAINER

    FDA 510(k)
    FDA Class 1 ·Pathology

    MODEL 400 ULTRA COMPACT VIDEO IMAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2014

    KIMVENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS, 8.0

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK HEALTH CARE·Product code BTR·February 22, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·January 26, 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