BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    ASTRA-T CALCIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Traverse

    FDA UDI
    Nuvasive, Inc.·00887517153432·Traverse Plate, Size 90 Fixed

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707079989·WEB 1ST MOLAR BANDS UR KIT

    STILLE Scissors

    FDA UDI
    Stille AB·07332339201326·STILLE VASCULAR SUPERCUT SCISSORS 90° 17 cm 6.7...

    FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)

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

    MODIFICATION TO TRANSSEPTAL INTRODUCER SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Visibly Digital Acuity Product

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SAFEPICO

    FDA Adverse Event
    Malfunction ·RADIOMETER AMERICA, INC·Product code CBF·May 15, 2014

    UNKNOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JDI·November 6, 2012

    LIMITORR VOLUME LIMITING EVD 20 ML

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·August 24, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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