BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    NAGASHIMA LIGHT SOURCE UNIT SL-5

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268217091·CUSTOM SURGICAL KIT ENDOVENOUS PACK

    ZFX DENTAL CAD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 20, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 6, 2012

    LIGACLIP*MCA MED

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDO·August 31, 2010

    BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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