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    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018

    Coulter Clone B6-FITC Reagent

    FDA Recall
    Terminated ·Beckman Coulter Inc·April 28, 2003

    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

    FDA Recall
    Terminated ·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·December 21, 2012

    US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure

    FDA Enforcement
    Class II ·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012

    Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) (2795). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (S27947). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.

    FDA Recall
    Terminated ·Invacare Corporation One Invacare Way·Product code LLI·June 9, 2003

    Stryker InTouch 1.0 Zoom Critical Care Bed (Model 2140) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·January 5, 2009

    Stryker InTouch 1.0 Critical Care Bed (Model 2130) with the Integrated PositionPro mattress (Model 2920) option. The device is intended to be used as an Intensive Care Unit bed.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·January 5, 2009

    Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·September 23, 2011

    US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure

    FDA Recall
    Terminated ·Non-Invasive Monitoring Systems, Inc.·Product code IRO·May 7, 2012

    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X and 1125XE.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·December 9, 2015

    74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code ONB·February 25, 2016

    Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped 60 units/box and 4 boxes/shipping carton Corvida Medical, Coralville, IA 52241.

    FDA Recall
    Terminated ·J & J Solutions, Inc. DBA Corvida Medical·Product code ONB·November 22, 2016

    icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code ONB·January 3, 2019

    30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of fluids.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code ONB·February 25, 2016

    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code ONB·February 25, 2016

    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code ONB·February 25, 2016

    110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of fluids.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code ONB·February 25, 2016