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

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    SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-

    FDA 510(k)
    FDA Class 1 ·Hematology

    EMD THERMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    FibroScan

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHOULDER GENERAL HUMERAL REAMING GUIDE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LXH·January 14, 2021

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 5, 2014

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 1, 2010

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 26, 2012

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015