BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NUVASIVE NEURO VISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SCALED DRILL 2.5MM, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code LXH·September 23, 2020

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014

    ENPULSE

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·November 3, 2010

    HEALICOIL - PK

    FDA Adverse Event
    Malfunction ·MANSFIELD MANUFACTURING SITE·Product code MBI·December 29, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024