BEUDAMED
    13 results · 27ms · Sources: EU EUDAMED, US FDA

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    PACEMAKER PROGRAMMER 2030

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B67882023040·Compressor Distractor Wand - Inner, 4in

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B67882023060·Compressor Distractor Wand - Inner, 6in

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B67882023020·Compressor Distractor Wand - Inner, 2in

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DIASOL-BICARB

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 31, 2012

    VELOCITY DELIVERY MICROCATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code DQY·June 4, 2015

    POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code LJT·August 10, 2022

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 6, 2023

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 6, 2023

    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