BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    FLEXICAIR LOW AIRLOSS THERAPY UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TITAN

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code FHW·November 12, 2020

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QYT·October 20, 2025

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 17, 2013

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

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

    COULTER LH 780 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