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

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    BACTIGEN SALMONELLA-SHIGELLA TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ORTHOPANTOMOGRAPH OP 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 12, 2014

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 6, 2010

    LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM LEFT-STERILE

    FDA Adverse Event
    Injury ·SYNTHES·Product code HRS·December 12, 2012

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015