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FDA releases the form FDA-483 with 14 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing faci...[ Price : $8.95]
FDA clears an iCardio.ai 510(k) for its artificial intelligence software EchoMeasure for interpreting echocardiography.[ Price : $8.95]
FDA gives the green light to Iota Biosciences for an early feasibility study of its investigational implantable device in underact...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Endosseous Dental Implants and Endosseous Dental Implant Ab...[ Price : $8.95]
FDA approves a Bausch + Lomb PMA for its EnVista Envy intraocular lens for use in cataract surgery.[ Price : $8.95]
GSK says it will submit a BLA based on positive data from two Phase 3 trials evaluating depemokimab in chronic rhinosinusitis with...[ Price : $8.95]
FDA clears a Heidelberg Engineering 510(k) for its Spectralis Flex Module for imaging the posterior segment of pediatric and adult...[ Price : $8.95]
Federal Register notice: FDA announces that it approved on 9/17 a product application that redeemed a priority review voucher Nova...