BEUDAMED
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    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    SOMATOM Force, System x-ray, tomography, computed

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 14, 2016

    Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881850558

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·March 24, 2021

    Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881833558

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·March 24, 2021

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging·March 23, 2016

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry·June 14, 2017

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 1, 2014

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·July 5, 2017

    EOS System X- ray beam Digital radiography system used in general radiographic examinations.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 15, 2014

    IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging·October 4, 2017

    sterEOS workstation

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·September 26, 2018

    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·April 21, 2021

    LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·December 25, 2019

    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·August 31, 2016

    Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·August 31, 2016

    IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·April 4, 2018

    Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·August 31, 2016

    Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·May 24, 2017

    Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging

    FDA Enforcement
    Class II ·Terminated·Ziehm Imaging Inc·August 31, 2016

    IMRIS T2X Table, Part Number 109682-600

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging, Inc.·March 21, 2018