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Sponsor Presentation posted for February 19, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
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Updated: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication
Date Issued: November 13, 2015Updated: February 23, 2016 The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order. On November 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom…
24 Hour Summary posted for February 18, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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24 Hour Summary posted for February 19, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
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CDRH Industry Basics Workshop
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Presentation and Transcript added to Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance
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PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication
Date Issued: February 19, 2016 Audience: Users of the PENTAX Medical (PENTAX) ED-3490TK Video Duodenoscope and reprocessing facilities including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties: Gastroenterology, Infection Control Device: PENTAX ED-3490TK Video Duodenoscope model PENTAX has issued updated,…
Slides added to Applying Human Factors and Usability Engineering to Medical Devices
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Letter to Endometrial Ablation Industry about Objective Performance Criteria
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