BEUDAMED
    116 results · 14ms · Sources: EU EUDAMED, US FDA

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    Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB).

    FDA Recall
    Terminated ·Ethicon Endo-Surgery·Product code MDM·December 15, 2004

    Powered stretcher chair used during facial and eye surgeries. One chair per package.

    FDA Recall
    Terminated ·TransMotion Medical Inc·Product code GBB·November 14, 2014

    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.

    FDA Recall
    Terminated ·Estill Medical Technologies, Inc·Product code BSB·July 25, 2014

    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 8, 2012

    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code LNH·June 6, 2018

    Warm Air Model 135 Warming Units.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products·Product code BTE·November 5, 2004

    Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products LLC·February 21, 2018

    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·June 11, 2014

    Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·December 11, 2013

    Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·February 25, 2015

    The Hemotherm 400CE 115v, containing power board p/n 39945

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·November 30, 2016

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013

    Hemotherm CE, model 400CE, Heater-Cooling Device

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·April 26, 2017

    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·September 3, 2013

    Electri-Cool II

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 18, 2005

    Hemotherm CE, model 400CE, Heater-Cooling Device

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWC·March 9, 2017

    WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convective heat transfer from the controller to a warm-air heated blanket

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·June 1, 2011

    115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·October 18, 2010

    The Hemotherm 400CE 115v, containing power board p/n 39945

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWS·November 7, 2016

    Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products LLC·Product code DWC·November 27, 2017