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

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    DVM-4200 BLOOD FLOWMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FORZA

    FDA UDI
    Orthofix US LLC·18257200078301·9W X 27L X 7H, 0DEG CURVED TRIAL

    Optiflux F180NR Dialyzer

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

    PARA-PAK SAF

    FDA 510(k)
    FDA Class 1 ·Pathology

    ELLIPSE DR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 24, 2014

    NEXGEN STEMMED TIBIAL COMPONENT PRECOAT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·October 28, 2010

    VALLEY LAB

    FDA Adverse Event
    Malfunction ·*·Product code GEI·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