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

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    VAGINAL SPECULUM - DISPOSABLE

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

    BANANA KNIFE - K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CAMELBACK HANDLE-K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    2.5MM & 4MM PROBE K841969-LABELING

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP

    FDA 510(k)
    FDA Class 2 ·Dental

    VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 30, 2014

    PROTIME 3 CUVETTE ASSAY

    FDA Adverse Event
    Injury ·INTERNATIONAL TECHNIDYNE CORP.·Product code GJS·November 14, 2012

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 8, 2015

    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