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    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 Recall
    Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012

    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 Recall
    Terminated ·Medisystems a NX Stage Company·Product code FIE·December 20, 2012

    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 Recall
    Terminated ·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Recall
    Terminated ·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021

    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 Recall
    Terminated ·Shimadzu Medical Systems·Product code IXR·March 31, 2016

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

    FDA Recall
    Terminated ·Medtronic·Product code FCG·February 8, 2017

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

    FDA Recall
    Terminated ·Medtronic·Product code FCG·February 8, 2017

    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 Recall
    Terminated ·Ansar Group, Inc. Dba Ansar Medical Technologies, Inc·Product code DRT·July 1, 2014

    Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.

    FDA Recall
    Terminated ·Phillips Nuclear Medicine·Product code INQ·January 26, 2009

    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 Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code MQB·May 12, 2014

    SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2020

    SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2020

    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2020

    Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code IYO·April 16, 2009

    GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)

    FDA Recall
    Terminated ·Ge Healthcare, Llc·Product code MQB·March 24, 2010

    GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·August 29, 2008

    Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector.

    FDA Recall
    Terminated ·GE Healthcare·Product code MQB·January 14, 2008

    GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy.

    FDA Recall
    Terminated ·OEC Medical Systems, Inc·Product code JAA·August 29, 2008