BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CONVERTORS

    FDA UDI
    Cardinal Health 200, LLC·50885380157873·SmartGown Breathable Surgical Gown, Xlarge

    FORZA

    FDA UDI
    Orthofix US LLC·18257200078097·7MM ROTATING CUTTER

    GEMENI IGG ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    X-RAY UNITS, GX-101, UCIS-510 AND GX-111

    FDA 510(k)
    FDA Class 2 ·Radiology

    GIALLOY CB-H

    FDA UDI
    SRL Dental GmbH·ESRL58904511·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...

    FORTIFY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    TRITON PUMP

    FDA Adverse Event
    Malfunction ·WALKMED INFUSION·Product code FRN·November 3, 2010

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·December 30, 2012

    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