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

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    WRIST SUPPORT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Buxton BioMedical

    FDA UDI
    Buxton Biomedical Inc·B7688236010·IVD Rongeur,str.,180x4mm

    Halyard

    FDA UDI
    O&M HALYARD, INC.·20680651682363·HALYARD,H400,STRWRP,-,36X36,150

    Legacy

    FDA UDI
    Gc Orthodontics America Inc.·E53582360100001·LEGACY 1. MOLAR LWR LFT SZ 01

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127020568·Head Trial 36mm x +0mm

    RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

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

    SINGLE USE REPOSITIONABLE CLIP

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

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 9, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 8, 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