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

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    21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Centaur Pedicle Screw System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215126780·

    RIGID GAS PERMEABLE CONTACT LENS SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

    SEQUOIA PREBENT ROD, CP TI 35MM

    FDA Adverse Event
    Malfunction ·ZIMMER SPINE·Product code NKB·April 5, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 23, 2008

    CELL-DYN EMERALD CLEANER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·April 20, 2016

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

    UNFOLDER PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

    BLUNT TIP SCREW, 4X34MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

    BLUNT TIP SCREW, 4X38MM

    FDA Adverse Event
    Injury ·ZIMMERSWITZERLAND MANUFACTURING GMBH·Product code HSB·December 19, 2022

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

    PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

    AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images. K110834: AW VolumeShare 5 is a review workstation, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis of diagnosis, except in the case of mammography images. K081985: AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·September 19, 2013