BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    NON CONDUCTIVE ANESTHESIA FACEMASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BK-6157-02 C.V.A SLING, MEDIUM&LARGE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LONG SCREWDRIVER WITH T-HANDLE FOR CLICK'X® LOCKING CAP

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXX·May 26, 2014

    NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·November 9, 2012

    ORTHO RESOLVE PANEL A

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·September 13, 2010

    NOVOPEN 4

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·May 11, 2022

    NOVOPEN 3

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·April 19, 2024

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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