BEUDAMED
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    IL 943 FLAME PHOTOMETER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Medipoint Blood Lancets

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACCESS TOTAL BHCG

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code GCC·January 22, 2021

    RELIANCE T HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·May 21, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 8, 2012

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 5, 2015

    LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET

    FDA Adverse Event
    Malfunction ·COOK VANDERGRIFT INC·Product code GCC·March 9, 2022

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·January 7, 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