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Presentation and Transcript posted for Color Additives for Medical Devices
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FDA strengthens requirements for metal-on-metal total hip replacement systems
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Letter to Sure Genomics, Inc. concerning SureDNA Test for Collection of Saliva Samples for DNA Sequencing
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Meeting Materials posted for February 19, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150001 added)
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Mammography Facility Adverse Event and Action Report
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Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
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Public Workshop
This workshop aims to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI). By convening the relevant stakeholders, the goal is to obtain input on the scientific, clinical, patient and regulatory considerations associated…
Class I Medical Device Recall: Dräger Medical Inc. Recalls Emergency Transport Ventilators Due to a System Error that may lead to a Halt in Ventilation Therapy
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