BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    STAR

    FDA UDI
    Stryker GmbH·00886385017457·Talar A/P Cut Guide Assembly, Left Medium

    COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ICG MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNIFY CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·April 26, 2013

    PENUMBRA COIL DETACHMENT HANDLE

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·April 7, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014