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Ellume COVID-19 Home Test and False Positive Results
Nov 10 – Update: FDA took additional actions related to the recall of certain lots of Ellume COVID-19 Home Tests.
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreNov 10 – Update: FDA took additional actions related to the recall of certain lots of Ellume COVID-19 Home Tests.
Oct 29 – Health care facilities: Do not purchase or use imported medical gloves from companies on Import Alert 80-04.
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Oct 29 - Before choosing implants, talk to your dental provider about potential benefits and risks of the procedure.
Oct 27 - The FDA took several new actions to help those who are considering breast implants make informed decisions.
Sep 30 - The FDA cleared Siemens NAEOTOM Alpha, a major technological improvement for Computed Tomography (CT) imaging.
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.