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Neurological Devices
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Product Labeling for Certain Ultrasonic Surgical Aspirator Devices
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Transcripts posted for October 25-26, 2016 Technical Electronic Product Radiation Safety Standards Committee
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Medical Device Reporting for Manufacturers
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Meeting materials posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
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MRI Safety Posters
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Webinar – Final Guidance on Medical Device Reporting for Manufacturers
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2014 Ebola Virus Emergency Use Authorizations: ReEBOV™ Antigen Rapid Test (Zalgen Labs, LLC)
On February 24, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the ReEBOV™ Antigen Rapid Test for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood, and…
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes
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