BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    DESERET UNIVERSAL LUER LOCK

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TOPCUT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PERIFUSE CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SMARTSITE EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPB·January 15, 2014

    RESTORE SENSOR

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

    CLEAR CARE LENS CARE SOLUTION

    FDA Adverse Event
    Injury ·CIBA VISION CANADA, INC., STERILE MANUFACTURING (CVSM)·Product code LPN·August 27, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 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