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

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    ANTI-ENA ANTIBODY TEST (SM)

    FDA 510(k)
    FDA Class 2 ·Immunology

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471118805·K-WIRE - DOUBLE TROCAR 0.8mm DIA x 125mm

    CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intense Pulsed Light Equipment

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

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2010

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 17, 2013

    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