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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140025 added)
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Implanted Blood Access Devices for Hemodialysis
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Meeting Notice: March 15-16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
Food and Drug Administration [Docket No. FDA-2015-N-0001] Circulatory System 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 meeting will be open to the public. Name…
Class I Medical Device Recall: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy
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Program Book
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Updates to Anaplastic Large Cell Lymphoma (ALCL) webpage
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. At that time, the Agency was aware of approximately 60 cases of ALCL in women with breast implants, out of approximately 5-10 million women who had received breast implants…
Postmarket Management of Cybersecurity in Medical Devices
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Summary Information for: KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM)
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