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

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    Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UNIVERSAL IRRIGATION SOLUTION HYBRID

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 3, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 30, 2014

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 20, 2011

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022