BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    PATIENT EXAMINATION GLOVE (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198925·AK3 Congruent Insert Trial Size 1, 14mm

    TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MALLORY/HEAD - PF ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 8, 2017

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·November 4, 2010

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·December 31, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    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