BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    ARIX Clavicle System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·June 20, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018