BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    BIOFIRE SPOTFIRE Respiratory (R) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INFINITY TOTAL ANKLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LORENZ SELF DRILLING SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 17, 2011

    MBT POR KEEL TIB TRAY SZ3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 27, 2008

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·July 3, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019