BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    INDIGO® Aspiration System – INDIGO Link

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Digital Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TargetCool™

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

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 22, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·August 1, 2013

    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