BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    FINGER PROTECTOR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EXPANDABLE KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Q50 PLUS STENT GRAFT BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 6, 2012

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 30, 2010

    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