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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150004, DEN150037, DEN150049 added)
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MDUFA III Performance Report
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Presentation and Transcript added to Webinar – Final Guidance on Medical Device Reporting for Manufacturers
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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
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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)
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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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