BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    ANGIO WASTE FLUIDS DUMP BAG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PYRAMID® +4 Anterior Lumbar Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000888121·PLATE 9874037 4HOLE 37MM

    PYRAMID® +4 Anterior Lumbar Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994286062·PLATE 9874037 4HOLE 37MM

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228740371·GC Initial™ Ti Opaqus Dentin ODB2, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704452·GC Initial™ AL Dentin DC4, 20g

    Ankeney Blade

    FDA UDI
    KOROS U.S.A., INC.·10840199536556·Ankeney Blades 35 x 35mm

    DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEPARIN COATED BALLOON THERMODILU

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORP·Product code FRN·January 21, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 15, 2010

    SYNREAM FLEXSHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·December 14, 2012

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013