BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA

    FDA 510(k)
    FDA Class 1 ·Hematology

    OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DAT TEST FOR CHAGAS' DISEASE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 16, 2014

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 19, 2010

    ADVIA 2120I WITH AUTOSAMPLER

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·December 14, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024