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

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    INTRA-AORTIC BALLOON SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLUCOSE-SL-C ASSAY, MODEL 257-30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VS Tabletop Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PICC SET: 2-L 16 GA X 19 - 1/2

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code LJS·February 20, 2014

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·October 24, 2012

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC·Product code NDN·August 26, 2010

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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