BEUDAMED
    25 results · 26ms · Sources: EU EUDAMED, US FDA

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    TINA-QUANT D-DIMER TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964153228·Endo Carry-on Procedure Kit contains Intercept ...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014134·Zirlux 16+ D4 98.5X20

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033265581·

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033265567·

    CORINNE MCCORMACK INC.

    FDA UDI
    FGX INTERNATIONAL INC.·00193033265574·

    NERIA GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 27, 2025

    OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·March 15, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 8, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020

    BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021

    BD TRUCOUNT¿ TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025

    Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 12, 2012

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018