GE Healthcares Datex-Ohmeda unit recalls its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says it became a...
Maquet Cardiovascular recalls its Atrium Express Dry Suction Dry Seal Chest Drain in response to a related components recall by another company due to...
More than 260 congressional Democrats ask the Supreme Court to reverse lower court rulings restricting the use of the medical abortion drug mifepristo...
Just two days after agreeing to a consent decree, FDA says that Philips Respironics reported over 7,000 medical device reports and 111 death reports f...
Federal Register notice: FDA corrects a 12/21/2023 notice announcing the availability of a final guidance entitled Development of Monoclonal Antibody ...
CDRH director Jeffrey Shuren says the Center will propose down-classifying many in vitro diagnostic tests from Class 3 to Class 2 in the hope of incre...
Some 29 advocacy groups call on FDA to act quickly to finalize a ban on electric skin shock devices used to treat self-injurious or aggressive behavio...
FDA warns Thailands S&J International Enterprises about CGMP violations in its production of finished drugs and refusing to allow some records to be c...
