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

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    ARIES MRSA Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FUJIFILM DUODENOSCOPE MODEL ED-580T

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDT·September 5, 2023

    FUJIFILM ENDOSCOPE

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDS·March 18, 2022

    FUJIFILM DUODENOSCOPE ED-580T

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDT·March 5, 2025

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 2, 2015

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    IDENTITY ADX XL DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 4, 2011

    FT3 - FREE TRIIODOTHYRONINE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CDP·October 30, 2015

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016