BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    IAMIN WET DRESSING (COPPER-SALINE)

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRACHEOBRONCHIAL SUCTION CATHETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·May 23, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 15, 2013

    LINE SET FOR AQUARIUS

    FDA Adverse Event
    Malfunction ·HAEMOTRONICS SPA·Product code FJK·January 19, 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