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Federal Register notice: FDA announces a 12/12 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committ...[ Price : $8.95]
FDA clears a TransEnterix Surgical 510(k) for the Senhance System, a new robotically-assisted surgical device (RASD) for use in mi...[ Price : $8.95]
FDA accepts a Prometic BLA for Ryplazim (plasminogen), indicated for treating plasminogen deficiency.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance on Assessing User Fees Under the Prescription Drug User Fee Amendmen...[ Price : $8.95]
Commissioner Scott Gottlieb says FDA has been expediting reviews and approvals of different dosage forms and generic versions of p...[ Price : $8.95]
FDA clears a NuVasive 510(k) for an expanded use of its Precice system to now include open and closed fracture fixation, pseudoart...[ Price : $8.95]
FDA clears a Siemens Medical Solutions 510(k) for the first seven-tesla magnetic resonance imaging device, Magnetom Terra, which m...[ Price : $8.95]
Attorney Adrienne Lenz reviews new FDA guidance on the least burdensome requirement for medical device deficiency letter.