medical devices Archives - Page 8 of 258

Class I Medical Device Recall: Centurion Recalls Multi-Med Single Lumen Catheters due to Excess Material that May Split or Separate

Emergency Use Authorizations: Zika ELITe MGB® Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)

On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…

Presentation and Transcript added to Webinar – Final Guidance on Medical Device Reporting for Manufacturers

MDUFA III Performance Report

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Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids

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A Message from the Director, Division of Mammography Quality Standards (DMQS): EQUIP

First, I want to thank everyone for the very positive feedback we have received about the series of articles on MQSA topics which we launched in 2015. We are glad that you have found them informative and relevant. You can send any suggestions for future topics to [email protected]. As you know, on October 27, 2016,…

Transcripts posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Class I Medical Device Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Products: Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Micro Catheter, and X-Celerator Hydrophilic Exchange Guidewire Lot Numbers: See full list of lot numbers Distribution Dates: November…

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140040 added)

Presentation and Transcript added to Webinar – Final Guidance Documents: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

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