BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    HANDI-LIFT/VICTORY WHEELCHAIR LIFT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SensiTox C. difficile Toxin Test

    FDA 510(k)
    FDA Class 1 ·Microbiology

    VERSION OF A CLOSED-FLOW SYS. CALORIC

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET

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

    QUICKSET 1PC FLEX DRILL BIT 45

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·June 25, 2014

    SARGON IMPLANT

    FDA Adverse Event
    Injury ·BIO-DENT, INC.·Product code DZE·October 28, 2008

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 8, 2010

    LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET

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

    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 7, 2018

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 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