BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

    FDA 510(k)
    FDA Class 2 ·Immunology

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 29, 2022

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 10, 2023

    ALARA T210 COMPUTED RADIOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SKLAR SURGICAL GOWN

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

    REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·June 5, 2020

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022

    O3 PEDIATRIC SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NKM·October 17, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 11, 2013