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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283372·BABY RIBBON RETRACTOR 6" x 1/2"

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776313760·Ribbon Retractor,

    MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    IBAL UKA, TIBIAL IMPACTOR

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·December 24, 2024

    IBAL UKA, TIBIAL IMPACTOR

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·February 12, 2025

    RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·April 10, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 12, 2011

    HI-TORQUE PILOT GUIDE WIRE

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·May 23, 2008

    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·June 20, 2018