The Food and Drug Administration (FDA) is announcing a public Workshop “Acute Ischemic Stroke Medical Devices Trials.” The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with acute ischemic stroke medical devices. Ideas generated during this workshop may facilitate further development of guidance regarding the…
Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire), and Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)
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: PROMUS Element Plus Everolimus-Eluting Platinum…
Class I Medical Device Recall: Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator Intake Port Blockage
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Class I Medical Device Recall: FLOW-i Anesthesia Systems
Use: The Flow-i Anesthesia System administers anesthesia while providing ventilation to patients with no or limited ability to breathe. The system is used in hospitals, for use in a range of patients from neonatal to adult. Recall Class: Class I Date Recall Initiated: April 2, 2015 Device: FLOW-i Anesthesia Systems Article Numbers: 66 77 200,…
Summary Information for: PROMUS Element™ Plus and Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent Systems (Monorail™ and Over-the-Wire)
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Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings
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Information on Personal Protective Equipment (PPE)
Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. PPE is commonly used in health care settings such as hospitals, doctor’s offices or clinical labs. When used properly, PPE acts as…
Unique Device Identification: Direct Marking of Devices
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