FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication

Date Issued: December 23, 2015 Audience: Users and reprocessors of the FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) ED-530XT duodenoscope, as well as users of Fuji’s ED-250XL5, ED-250XT5, ED-450XL5 and ED-450XT5 duodenoscopes including: Gastroenterologists Gastrointestinal surgeons Endoscopy nurses Staff working in endoscopy reprocessing units in health care facilities Infection control practitioners Facility risk managers Medical Specialties:…

Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication

Updated: December 22, 2015 Previously Issued as FDA Safety Notification on Dec. 16, 2010 Audiences: Consumers/Parents who may consider purchasing laser pointers Health care providers who identify and treat injuries to the eyes or skin Medical Specialties: Primary Care, Pediatrics, Ophthalmology, Emergency Room and Urgent Care Providers Product: Hand-held laser pointers Purpose: The FDA wants…

Updated Information on Tanning

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Consumer Information on: LifeVest Wearable Cardioverter Defibrillator

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: LifeVest Wearable Cardioverter Defibrillator, Models…