BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Flexible Suturing System with Anchors (FSSA)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DTE

    FDA UDI
    Guilin Woodpecker Medical Instrument Co., Ltd.·06944843657769·Dental X-Ray Device

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982157232·4.0MM LOCKING SCREW 46MM

    DFP4343C7

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    FDA Adverse Event
    Malfunction ·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

    SUPER POLIGRIP COMFORT SEAL STRIP

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·August 16, 2011

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 12, 2013

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 28, 2023

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 25, 2025

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 30, 2025

    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