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

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    ANTI-ENA ANTIBODY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACS ADVANCED CONCEPT GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AML HIGH OFFSET LG STAT 16.5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 17, 2013

    0.5ML PATIENT CONTROL MODULEJAPAN

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 10, 2010

    COULTER LH 500 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 8, 2014

    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