BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    EMIT-AMD AMIKACIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEBO Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODEL AFR EEG TELEPHONE RECEIVER

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2014

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·November 27, 2007

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

    NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    FDA Enforcement
    Class II ·Terminated·Navilyst Medical, Inc·March 4, 2015

    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