Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities unused inventory.
FDA warns against the use of over-the-counter anti-choking devices because they are not approved or cleared by the agency.
FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.
FDA announces that its Medical Devices Advisory Committees Molecular and Clinical Genetics Panel is scheduled to review a Guardant Health PMA for its ...
FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...
Endos Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the p...
Federal Register notice: FDA seeks comments on an information collection extension entitled Data To Support Social and Behavioral Research as Used by ...
Pharmaceutical Research and Manufacturers of America urges FDA to hold more meetings on innovative clinical trial approaches to allow more discussion ...
