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

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    Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NIO 5MP-21 AND MDNG-5121 CB

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLSTICE

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 9, 2024

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 29, 2013

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 14, 2011

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

    FDA Enforcement
    Class II ·Ongoing·Quidel Corporation·May 1, 2024