BEUDAMED
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    MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190

    FDA 510(k)
    FDA Class 2 ·Radiology

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517208682·ARM15T Rod, 95mm Conventional Pre-Bent

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code JDS·February 13, 2017

    SNAP MODEL 6

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QUIK-COMBO PACING/DEFIBRILLATION/ECG

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998

    RETRACTOR HANDLE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code GAD·April 11, 2013

    ACUITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code OJX·April 12, 2011

    RINGLOC BI-POLAR CUP

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code JDI·May 20, 2008

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 5, 2016

    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

    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 Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 20, 2013