FDA warns Abbott about QS violations at its Sylmar, CA, manufacturing facility.
The former CEO of Action Packing and Design, Paul Rodriguez, pleads guilty to trafficking in counterfeit labels and packaging.
FDA clears a Ventec Life Systems 510(k) for VOCSN, a portable life support device that combines five respiratory therapies ventilation, oxygen, cough...
FDA clears a United Orthopedic 510(k) for its E-XPE polyethylene knee insert that is designed to provide patients with knee replacements with reduced ...
FDA permits marketing of the Philips IntelliSite Pathology Solution whole slide digital imaging system.
Purdue resubmits at the suggestion of FDA its petition asking for restrictions to ensure the safety and effectiveness of follow-on products citing But...
The Campaign for Mercury Free Dentistry petitions FDA to warn dentists and their patients that amalgam should not be used in children under age 15, pr...
President Trump lifts his January-ordered hiring freeze affecting FDA and other agencies, and instead he has ordered agencies to take immediate action...