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

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    OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Sherpa Pak Kidney Transport System

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

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·December 30, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020