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

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    V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209136216·

    MONOCULAR DIRECT OPHTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SERIES 7000/HOLTER RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·August 22, 2016

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 9, 2014

    SENSIA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code NVZ·October 5, 2010

    DYNAMIC Y STENT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code NYT·December 3, 2012

    SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

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

    1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·April 13, 2022

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017