BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SONIC, MODEL SO-100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    2027971-2022-050593

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·March 14, 2022

    Richli

    FDA UDI
    COOK INCORPORATED·00827002135475·Richli Pneumothorax Set Ultrathane,

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·April 10, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 15, 2011

    TENDRIL DX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022