BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    UNISTIK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    APEX INTRAMEDULLARY NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERFORMAX PEDIATRIC EE TOTAL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·December 10, 2010

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021