FDA clears an Edap TMS 510(k) for its Focal One device for ablating prostate tissue.
Federal Register notice: FDA corrects a 5/15 proposed rule to amend its regulations concerning the classification of products as biological products, ...
Federal Register notice: FDA announces a 6/27 public workshop entitled Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic F...
Federal Register notice: FDA classifies the in vivo cured intramedullary fixation rod into Class 2 (special controls).
Federal Register notice: FDA announces the renewal of the Pulmonary-Allergy Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA submits a proposed extension for a collection of information on Medical Device Reporting: Electronic Submission Requireme...
TransEnterix files a 510(k) for additional Senhance System instruments, including 3mm diameter instruments for abdominal surgery.
A northern Mississippi judge enters a consent decree of permanent injunction against Delta Pharma (Ripley, MS) and two company officials after failing...