BEUDAMED
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    SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGITRON IEC II

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

    SAFE-STEER GUIDE WIRE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PIIC CLASSIC UPGRADE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024

    OT VERIO IQ METER

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

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 9, 2011

    MICROMAX SYSTEM MOTORS

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBB·July 22, 2008

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 28, 2022

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    FDA Enforcement
    Class III ·Terminated·Angiodynamics, Inc.·December 28, 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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012