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

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    GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gammex PI Breach Detect Powder Free Surgical Glove

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BVI BEAVER6600

    FDA Adverse Event
    Malfunction ·BECTON VISITEC INTERNATIONAL, INC.·Product code GES·February 4, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 8, 2014

    CLEARVIEW BLOWER/MISTER

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code FQH·January 7, 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