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

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    ENSWELL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    QUICKVUE INFLUENZA A+B TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SW-THERM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 6, 2014

    DELTEC COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)·Product code LZG·September 7, 2010

    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·August 14, 2019

    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