BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS

    Device
    EU MDR · Eu Md Class 2b ·Hangzhou AGS MedTech Co.,Ltd.·On the market·32 countries

    COTTON ROLLS

    FDA 510(k)
    FDA Class 1 ·Dental

    Masimo O3 Regional Oximeter System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    COULTER AC·T DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 18, 2014

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·October 20, 2010

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·December 20, 2012

    Podiatry Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015