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Update on the status of FDA’s evaluation of the Essure System
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Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication
Date Issued: November 23, 2015 Audience: Health care providers who treat patients during or after intravascular procedures Health care providers who interpret imaging studies or study tissue samples following intravascular procedures Device: Medical devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems are commonly used during minimally invasive procedures…
Meeting Notice: February 19 , 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
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; 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…
Presentations and Webcast Replay added to Public Workshop – Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop, November 19
The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, “Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices Workshop.” The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus…
Meeting Notice: February 19, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
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; 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…
Presentations and Webcast added to Public Workshop
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Consumer Information on: cobas®HCV Test
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Consumer Information on: PD-L1 IHC 28-8 pharmDx
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Presentations added to CDRH Industry Basics Workshop – Purchasing Controls & Process Validation
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