BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PE/Cyanine7 anti-human CD10

    FDA UDI
    BIOLEGEND, INC.·00810034701305·URL: https://www.biolegend.com/en-us/products/p...

    TiWAVE-L Porous Titanium Lumbar Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION INC·Product code DRM·January 25, 2013

    ERCHONIA

    FDA Adverse Event
    Other ·ERCHONIA CORP·Product code GEX·February 3, 2011

    COULTER ACT DIFF ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·August 5, 2014

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021