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 ...
Draeger Medical recalls its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while operating on battery pow...
FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous...
FDA clears a Cochlear 510(k) to lower the patient age for its Cochlear Osia System from 12 years to five years for children with conductive hearing lo...
