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

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    STAPHYLASE TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    QKO (TM) AMYLASE B-HA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MR 700 MICROPLATE READER 012-700-1000

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 18, 2014

    CAROTID WALLSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIM·October 19, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 14, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024