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

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    Aeroneb USB Contoller System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SAFETY SCREW CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LIFECARE CONDUCTIVE GARMENTS

    FDA 510(k)
    FDA Class 2 ·Neurology

    POWERHEART G5 AUTOMATIC AED

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 3, 2011

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015