BEUDAMED
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    Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector

    FDA Enforcement
    Class II ·Terminated·Medisystems a NX Stage Company·January 30, 2013

    Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.

    FDA Enforcement
    Class II ·Terminated·Medisystems a NX Stage Company·January 30, 2013

    Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES

    FDA Enforcement
    Class II ·Ongoing·Vortex Surgical Inc.·February 11, 2026

    Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000.

    FDA Enforcement
    Class II ·Terminated·Ansar Group, Inc. Dba Ansar Medical Technologies, Inc·August 27, 2014

    Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the X-ray tube unit. This unit is used for radiographic examinations of whole body except mammography when combined with an X-ray high voltage generator, an X-ray tube unit, an X-ray collimator, and if necessary, an X-ray radiography stand, an X-ray radiography table, and digital radiography system.

    FDA Enforcement
    Class II ·Ongoing·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION·November 19, 2025

    The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·February 28, 2024

    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

    BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

    FDA Enforcement
    Class II ·Terminated·Medtronic·March 22, 2017

    BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

    FDA Enforcement
    Class II ·Terminated·Medtronic·March 22, 2017

    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·May 4, 2016

    Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·August 21, 2013

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·June 11, 2014

    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Enforcement
    Class II ·Ongoing·First Source Inc·July 10, 2024

    Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762471

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024

    LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 11574100

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Enforcement
    Class II ·Ongoing·First Source Inc·July 10, 2024

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Enforcement
    Class II ·Ongoing·On-X Life Technologies, Inc.·May 20, 2026

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017

    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems Usa Com·July 5, 2017

    Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Number: 10860700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 14, 2024