BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Gas Module 3

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VIVASCOPE SYSTEM, MODEL 1500, 3000

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

    COCR RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRANSCEND 365 MINICPAP SYSTEM

    FDA Adverse Event
    Injury ·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021

    COULTER® ACT 8/10 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 20, 2013

    ADMIRAL XTREME PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·INVATEC INNOVATIVE TECHNOLOGIES, SPA.·Product code LIT·April 28, 2011

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 22, 2008

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    SenTec Membrane Changer Insert [5 pcs - 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