BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    Upper ROC Kit for Herbst

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199006250·

    ARCHITECT I2000SR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·July 18, 2023

    WIRELESS PORTABLE DETECTOR FD-W17

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCANDINAVIAN IVF SCIENCES AB, G1.2

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

    I-STAT CELITE ACT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JJE·December 6, 2010

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEATHCARE CORPORATION·Product code KDJ·June 27, 2014

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·January 7, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·November 8, 2010

    I-STAT KAOLIN ACT AND CELITE ACT CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JBP·October 7, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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