[ Price : $8.95]
FDA accepts for review a U-Systems PMA for a breast cancer screening indication for the somo*v Automated Breast Ultrasound (ABUS) ...[ Price : $8.95]
Baxter recalls six lots of Gammagard Liquid [immune globulin intravenous (human)] 10%, 1g size, due to the potential for metallic ...[ Price : $8.95]
FDA clears a Fresenius Medical Care 510(k) for the 2008K@home, a hemodialysis system for home use.[ Price : $8.95]
FDA clears an Ethicon Endo-Surgery 510(k) for the Enseal G2 Curved and Straight Tissue Sealers, intended for use in providing vess...[ Price : $8.95]
CDRH issues a SOP on decision levels for requests for additional or changed information for premarket submissions.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance, Investigational Device Exemptions for Early Feasibility Medical Device Cli...[ Price : $8.95]
FDA issues guidances to promote early-stage development of medical devices, including initial trials in humans.[ Price : $8.95]
Rep. Dan Burton introduces a bill to move the date used to determine a dietary ingredient that is eligible to be grandfathered.