medical devices Archives - Page 9 of 258

Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes

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Emergency Use Authorizations: Abbott RealTime Zika

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…

Class I Medical Device Recall: SentreHeart Recalls FindrWIRZ Guidewire System due to Coating Separation

Webcast and Presentations added to Public Workshop on Promoting Semantic Interoperability of Laboratory Data, November 8, 2016

The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS) announced the following public workshop titled “CDC/FDA/NLM/ONC/CMS Workshop…

Essure Labeling Information for Patients and Health Care Providers (Updated)

24 HourSummary posted for November 10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

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Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

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24 HourSummary posted for November 9, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

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Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Controllers Due to Loose Connector Ports

Updated Essure Activities and Information for Patients and Providers

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