BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

    FDA 510(k)
    FDA Class 2 ·Immunology

    FT4, FREE THYROXINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016

    Prodigy AutoCode Blood Glucose Monitoring System

    FDA UDI
    Prodigy Diabetes Care, LLC·00384840518902·Prodigy AutoCode Blood Glucose Monitoring Syste...

    G-2 VERSION 3, MODEL 10049

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·May 13, 2008

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 12, 2011

    ECC.O SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code KFM·February 29, 2016

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022