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Summary Information for: Perceval Sutureless Heart Valve
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Summary Information for: Storz Medical Duolith SD1 Shock Wave Therapy Device, Models T-Top and Tower
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Meeting Notice: February 25-26, 2016: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The…
MedSun Newsletter #115, January 2016
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Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop titled “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.” The topic to be discussed is the appropriate level of Good Manufacturing Practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices. Date, Time and Location Federal Register Notice Webcast…
Amendment of Meeting Notice: February 19, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and…
CDRH Industry Basics Workshop
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140018 added)
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La FDA le recomienda a los proveedores de servicios de salud detener el uso de los paquetes y bandejas con material quirúrgico de Customed, Inc.: Comunicación de Seguridad de la FDA
English Fecha de publicación: 5 de enero de 2016 De interés para: Proveedores de servicios de salud en Puerto RicoPersonal que trabaja en los centros de salud u hospitales en Puerto Rico Producto: Los paquetes y las bandejas empacadas Customed contienen dispositivos y otros artículos que se usan durante procedimientos quirúrgicos, incluyendo procedimientos generales en hospitales,…