The FDA Safety Information and Adverse Event Reporting Program
- Requesting Speakers from CDRH
- Upcoming Webinar on Hearing Aids: The Basic Information You Need to Know (5/23/12)
- Federal Register: Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comments
- Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability
- FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
- Pediatric X-ray Imaging
- Draft Guidance for Industry and Food and Drug Administration Staff – Pediatric Information for X-ray Imaging Device Premarket Notifications
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Inspection by Accredited Persons Program
- Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
- Public Workshop – Device Improvements for Pediatric X-ray Imaging, July 16, 2012
- Consumer Information on: Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) – H100004
- Federal Register: Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals; Public Workshop
- Mammography Facility Adverse Event and Action Report – May 2, 2012
- Summary Information for: Presillion plus CoCr Coronary Stent on RX System
- Consumer Information on: Presillion plus CoCr Coronary Stent on RX System – P110004
- Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
- Summary Information for: Epic? Vascular Self-Expanding Stent System
- In Vitro Companion Diagnostic Devices
- Summary Information for: BONDTM ORACLETM Human Epidermal Growth Factor Receptor 2 (HER2 ) Immunohistochemical (IHC) System
- Consumer Information on: Epic? Vascular Self-Expanding Stent System – P110035
- Consumer Information on: BOND? ORACLE? Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System – P090015
- Class I Medical Device Recall: Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays
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