Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Mammography Facility Adverse Event and Action Report
<!– –> <!– Page Last Updated: 03/19/2015 –> Page Last Updated: 03/19/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Public Workshop – An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment
The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Clinical Considerations of Risk in the Postmarket Environment.” The purpose of the workshop is to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator,…
Transcript posted for Feb. 20, 2015 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
%PDF-1.7 % 6752 0 obj stream xmo8_ogՊHzY,h^mIsnK4uǙ!-[h83!هE/{w`tr9,f۽Xt:=^,ﯦ?A@`a 8wqRmx J(@2pxLll6pRrۆatCGð~2/X{$2
Summary Information for: WATCHMAN LAA Closure Technology
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Meeting Notice:April 30
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Ear, Nose, and Throat 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…
Updated Infections Associated with Reprocessed Duodenoscopes
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than…
510(k) Final Decisions
<!– –> <!– Page Last Updated: 03/13/2015 –> Page Last Updated: 03/13/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Webinar: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Final Guidance
<!– –> <!– Page Last Updated: 03/12/2015 –> Page Last Updated: 03/12/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Updated Reprocessing of Reusable Medical Devices
Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes. When used on patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices undergo “reprocessing,” a…