BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    ADR-10600(ADR 400),10601 (ADR 300)

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

    SYNCHRON® AMYLASE (AMY) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JFJ·September 21, 2010

    CrossRoads Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMA MICROLYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OPTISENSE

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·May 5, 2014

    SCREW-IN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

    CONSULTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025