BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    CAMPYLOBACTER THIOGLYCOLLATE MED

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LED TURBO-PEN

    FDA 510(k)
    FDA Class 2 ·Dental

    ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CHLORAPREP ONE STEP

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·May 25, 2021

    BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS)

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·February 24, 2022

    BRILLIANCE 64

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·May 20, 2014

    135 DEG DHS PLATE-STANDARD BARREL 4 HOLES/78MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KTT·November 1, 2012

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 16, 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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023