BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    SPERM SELECT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Instruments

    FDA UDI
    Nuvasive, Inc.·00887517385123·ALGI Curette, Down Facing Medium

    AcQCross Qx Integrated Transseptal Dilator/Needle

    FDA UDI
    ACUTUS MEDICAL, INC.·00850027837598·

    FlexCath Cross™ Transseptal Solution

    FDA UDI
    MEDTRONIC, INC.·00763000925154·NDL 900308 FLEXCATH CROSS WT 75CM EIFU

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052027919·Drill ø 9 mm

    i-ED COIL

    FDA UDI
    KANEKA CORPORATION·04540778176591·The i-ED COIL is used for vascular embolization...

    FlexCath Cross Transseptal Solution

    FDA UDI
    ACUTUS MEDICAL, INC.·00850027837901·FlexCath Cross Transseptal Solution– WT 75cm

    Intervertebral Body Fusion Device

    FDA UDI
    PRECISION SPINE, INC.·00840019923293·TLIF Sizer 8mm x 24mm

    RESTEP DVY SYSTEM, MODEL RSP-101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WALLSTENT BILIARY ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 16, 2010

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·January 7, 2013

    VALIANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 27, 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