FDA clears a Zynex 510(k) for its TensWave, a transcutaneous electrical nerve stimulation therapy for reducing chronic and acute pain.
FDA clears a Ventis Medical 510(k) for the VM-2000, an emergency transport ventilator that allows medical personnel to provide respiratory support in ...
FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, Japan.
FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to manage diabetes.
Federal Register notice: FDA revokes a 2020 emergency use authorization granted to Roche Molecular Systems for the cobas SARS-CoV2 & Influenza A/B nuc...
Federal Register notice: FDA classifies intervertebral body graft containment devices into Class 2 (special controls).
FDA warns Atlanta, GA-based physician Julio Flamini about concerns related to investigations at his Clinical Integrative Research Center of Atlanta.
FDA warns Coral Gables, FL-based Mother Stem Institute about illegally marketing stromal vascular fraction products derived from donor adipose tissue ...
