BEUDAMED
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    Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physician with diagnosis. DX-G Digitizers provide the ability to use both standand needle phosphor image plates and can be used with either Musica or Musica 2. In the US, Agfa's Computed Radiography Systems with DX-G Digitizers are not intended for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·December 6, 2011

    DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·October 8, 2010

    Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code DSY·July 12, 2013

    Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code DSY·July 12, 2013

    GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography System).

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·February 5, 2007

    GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging system ( Cardiovascular Imaging System).

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·February 5, 2007

    GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular imaging system.).

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code MQB·February 5, 2007

    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code GCJ·November 21, 2014

    Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code GCJ·November 21, 2014

    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM)

    FDA Recall
    Terminated ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·March 5, 2014

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MHX·August 11, 2010

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Recall
    Terminated ·Heidelberg Engineering·Product code OBO·December 8, 2017

    CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.

    FDA Recall
    Terminated ·Partners In Medicine Llc·Product code DSB·December 1, 2015

    The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 20, 2018

    Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code IBG·August 2, 2018

    Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 56711-04-03, 5671-04-05, 56711-04-51, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer, List Number 50132-04-05, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code DXG·September 12, 2008