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    AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    JOBST SensiFoot

    FDA UDI
    BSN MEDICAL, INC.·00035664108342·SENSIFOOT 8-15 MM HG KNEE HIGH EXTRA LARGE WHIT...

    Posted Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90911083414·.018 X .025 POSTED SS RIGHT FORM WIRES 34MM (10)

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306805851·Kelly Retractor, 2-1/2" x 3"

    LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAIMAN DISP.INSTR.NON ARTICUL. D: 5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·June 17, 2015

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360 MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·June 17, 2015

    CAIMAN DISP.INSTR.NON ARTICUL. D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·June 17, 2015

    CONTOUR

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code GEI·November 1, 2015

    CAIMAN DISP. INSTR. NON ARTICUL.D:5 / 360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code GEI·August 13, 2015

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code GEI·February 18, 2016

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/ 360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code GEI·July 22, 2015

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GEI·February 27, 2015

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 10, 2014

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 1, 2011