BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    EDL NORMAL COAGULATION CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Myo Plus

    FDA 510(k)
    FDA Class 2 ·Neurology

    MONACO RTP SYSTEM, VMAT OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    CADD EXTENSION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD,INC.·Product code FPA·April 13, 2020

    EMPTY INTRAVIA CONTAINER (1000ML) GAMMA STERILIZED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 4, 2010

    PROMOTE QUADRA

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014

    EDGE CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION, INC.·Product code JAK·December 21, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012