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Transcript posted for November 14, 2014 Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting
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POSTPONED December 12, 2014: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting AGENCY:Â Food and Drug Administration, HHS. ACTION:Â Notice. SUMMARY:Â The Food and Drug Administration (FDA) is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel…
FDA Voice Blog: Implementing the Unique Device Identifier System into health care systems is critical for reaching its potential to benefit public health
By: Jeffrey Shuren, M.D., J.D. As the FDA works with manufacturers to launch a new system of identifying medical devices using standard bar codes and numbers, we look forward to the day when the system, called the Unique Device Identifier (UDI) system, will be fully set up— with identifiers on device labels and a corresponding…
510(k) Final Decisions
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Class I Medical Device Recall: CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs
Recall Class: Class I Date Recall Initiated: November 6, 2014 Devices: All lot codes of the following AED electrodes distributed between March 1, 2012 – October 29, 2014. Adult Radiotransparent Electrode Catalog Number: 2001H, 2001H-C, 2001H-PC, 2516H, 2516H-PC Pediatric Radiotranslucent Electrode Catalog Number: 2603H Mini Pediatric Radiotranslucent Electrode Catalog Number: 2602H Pediatric R2 Multifunction Electrode…
MedSun Newsletter #102, December 2014 (PDF
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Transcripts Added to Public Workshop – Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing, October 8
Date, Time and Location Federal Register Notice Webcast Transcripts Workshop Materials Agenda Contact Us Date, Time and Location This meeting was held October 8-9, 2014, beginning at 8:00 a.m. at the following location: FDA White Oak Campus 10903 New Hampshire Avenue Bldg. 31, Room 1503 (the Great Room) Silver Spring, MD, 20993 Webcast Main Session 10/8…
Class I Medical Device Recall: Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels
Recall Class: Class I Date Recall Initiated: October 17, 2014 Devices: Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 Manufacturing dates: November 1, 2013 – August 11, 2014 Distribution dates: December 2013 – September 2014 Use: These devices can identify certain gram negative bacteria and measure how these bacteria…
Updated MQSA National Statistics
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