BEUDAMED
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    DEL MAR MODEL 5500 EEG SCANNER

    FDA 510(k)
    FDA Class 2 ·Neurology

    Tranquil-C™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788227000·Cervical Rasp, Thin Shaft, 7x16x13, 6 deg

    PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DELUXE MANUAL WHEELCHAIR HW 4000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HEARTMATE II LVAS

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·February 12, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2012

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code JDI·August 26, 2010

    DVR CROSSLOCK 1.7 MM SQUARE DRIVER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWR·December 13, 2017

    NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161, 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