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

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    MRT-50GP

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bardex® I.C. Urine Meter Foley Tray

    FDA UDI
    C. R. Bard, Inc.·00801741019821·Bardex® I.C. Urine Meter Foley Tray

    Barco

    FDA UDI
    Barco NV·05415334050020·MDSC-8527 NXF M2

    OSI Q SYSTEM ARTHROSCOPES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STIMULONG PLUS CATHETER SET MODEL, VARIOUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 22, 2016

    13MM UNIVERSAL FEMORAL NAIL 400MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDS·December 14, 2010

    SUMMIT DUOFIX TAP SZ8 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 29, 2013

    SELF CENT HIP 52X28 BLU

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·July 14, 2014

    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