BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    KARE CHAIR I

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04046114938279·GENUMEDI PRO ROM SIZE VII

    Instruments

    FDA UDI
    Nuvasive, Inc.·00887517385116·ALGI Curette, Down Facing Small

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377092809·RELINE C Conn,3.5-4/3.5-4mm Top-Bottom

    Tibial Spacer

    FDA UDI
    ADLER ORTHO SPA·08052693620548·7 mm LB TIBIAL SPACER

    EBERLE

    FDA UDI
    Eberle GmbH & Co. KG·04050052027889·Guid wire drill ø 3.2 mm

    NA

    FDA UDI
    Stryker GmbH·00886385022369·Sigmoid Notch Radial Stem, Large

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746094804·DB BRACKET MASTER SERIES MAND 2ND BICUSPID 5MM ...

    FlexCath Cross Transseptal Solution

    FDA UDI
    ACUTUS MEDICAL, INC.·00850027837888·FlexCath Cross Transseptal Solution– MH 81cm

    ShurFit Interbody Device

    FDA UDI
    PRECISION SPINE, INC.·00840019930819·TLIF Sizer 7mm x 24mm

    GELSCAN, MODEL 1206

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DDI ULTRASONIC NEBULIZER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CVC SET: 3-LUMEN 12 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·May 2, 2014

    OT ULTRALINK METER

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

    PLATE

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

    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·August 26, 2015

    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