October 20, 2016 By U.S. Food & Drug Administration UPDATE: Mycobacterium Chimaera Infections Associated With LivaNova PLC Stӧckert 3T Heater-Cooler System: FDA Safety Communication
October 19, 2016 By U.S. Food & Drug Administration Medtronic Neurovascular Products: Recall – Potential Separation And Detachment of Polytetrafluoroethylene (PTFE) Coating
August 5, 2016 By U.S. Food & Drug Administration FDA Releases Final Guidance on Adaptive Medical Device Study Designs
March 14, 2015 By U.S. Food & Drug Administration FDA Approves CPR Devices that May Increase Chance of Surviving Cardiac Arrest
January 6, 2014 By U.S. Food & Drug Administration Class I Medical Device Recall: Abbott Diabetes Care, FreeStyle and FreeStyle Lite Blood Glucose Test Strips – Erroneously Low Blood Glucose Results
December 3, 2013 By U.S. Food & Drug Administration Voluntary Recall of Philips Automated External Defibrillators
November 22, 2013 By U.S. Food & Drug Administration Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only – Guidance for Industry and Food and Drug Administration Staff
November 15, 2013 By U.S. Food & Drug Administration Consumer Information on: MitraClip Clip Delivery System
November 12, 2013 By U.S. Food & Drug Administration Class I Medical Device Recall: Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) System Kit and the ForeCYTE Breast Health Test – Marketing Without Approval or Clearance
November 12, 2013 By U.S. Food & Drug Administration Meeting Notice: December 11, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
October 17, 2013 By U.S. Food & Drug Administration Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO)
September 9, 2013 By U.S. Food & Drug Administration Meeting Announcement: October 8-9, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee
August 13, 2013 By U.S. Food & Drug Administration Meeting Notice: September 11-12, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee
August 8, 2013 By U.S. Food & Drug Administration Class I Medical Device Recall: Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter