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

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    THE MODEL 3003 SCALER

    FDA 510(k)
    FDA Class 2 ·Dental

    DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013

    DELTA SHUNT KIT REGULAR, PL 1.5

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·December 14, 2010

    SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 12, 2014

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024