Consumer Information on: KAMRA Inlay

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PMA Final Decisions for February 2015

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Meeting Materials posted for April 30

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Posted Presentations and Webcast to Public Workshop – An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment

The Food and Drug Administration (FDA) announced a public Workshop entitled “Clinical Considerations of Risk in the Postmarket Environment.” The purpose of the workshop was 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, or…

Class I Medical Device Recall: LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits

Recall Class: Class I Date Recall Initiated: March 13, 2015 Product: Ebola Virus One-Step Test Kits Product Codes and Lot Numbers: All lots of the Ebola Virus One-Step Test kits are affected by this recall. The affected devices were sold in California and exported internationally to Sierra Leone, Canada, and Denmark between October 2014 and…