BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    BONE INJECTION GUN (B.I.G.) DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

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

    Alere BinaxNOW Influenza A & B Card 2, Alere Reader

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    GENTEEL HOMECARE PRODUCTS·Product code ITJ·February 27, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·February 2, 2011

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 5, 2014

    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