BEUDAMED
    11 results · 32ms · Sources: EU EUDAMED, US FDA

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    Eve Patient Positioner System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALT LASER, MODEL VTR 75

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    COBAS 6000 E 601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 7, 2018

    COBAS 8000 E 602 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·December 19, 2017

    TWO TIER LYME DISEASE TESTING DEARBORN

    FDA Adverse Event
    Injury ·Product code LSR·October 31, 2014

    CAPTURA SERRATED LARGE FORCEP-SPIKE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code FCL·August 15, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 17, 2013

    KIDS OXYGENATOR D101

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 4, 2025

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022