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

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    CUSTOM BURN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CHAD LABS ADHESIVE BANDAGE REMOVER

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

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 23, 2015

    ACTIVA PC

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·December 3, 2010

    TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

    FDA Adverse Event
    Injury ·COVIDIEN·Product code MCW·July 15, 2014

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015