BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Wound Treatment System (VHT-200)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188582·Integra® Jarit® Hibbs Gouge, 9-1/2", Straight, ...

    SMV Scientific 4.5 mm Bone Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPIGUARD

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014

    ASR ACETABULAR IMPLANT 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 15, 2011

    MIDLINE CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DQY·July 24, 2013

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013