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

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    P-S MED. LUMBO PERITONEAL & VENTRICULO-

    FDA 510(k)
    FDA Class 2 ·Neurology

    DBB-05 HEMODIALYSIS DELIVERY SYSTEM

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

    SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 1, 2014

    PRTX MONO POLY LITE MSH 20X20C

    FDA Adverse Event
    Malfunction ·SOFRADIM PRODUCTION·Product code FTL·October 8, 2012

    PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK

    FDA Adverse Event
    Injury ·MEDELA INC.·Product code HGX·June 5, 2015

    PEDIATRIC LCP HIP PLATE 2.7MM/130°/2 HOLES-STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·April 22, 2019

    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