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

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    MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Well Lead Extraction Bag

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

    DEKNA-LOK MODEL BP1000V2L

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

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2014

    ACCU-CHEK ® ACTIVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 7, 2010

    12/14 ARTICUL 40MM M SPEC+5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·December 6, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012