BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    CALI-PIPETTE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PressON™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788203460·Wand – Outer, 100mm

    STERLING

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975063700·

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020

    Lotus Prophy Angle

    FDA 510(k)
    FDA Class 1 ·Dental

    CLEANER ROTATIONAL THROMBECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 9, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 6, 2012

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·August 30, 2010

    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