Smiths Medical recalls (Class 1 device correction) its ParaPAC Plus P300 and P310 Ventilators due to inadvertent tidal volume knob movement.
FDA awards de novo marketing clearance to Germitecs Chronos automated disinfection device for reducing the risk of cross-contamination with ultrasound...
Federal Register notice: FDA makes available a final guidance entitled Clarification of Radiation Control Regulations for Manufacturers of Diagnostic ...
FDA commissioner Robert Califf and other top officials outline areas the agency believes can be optimized to help improve the advice received from adv...
FDA approves Establishment Labs Holdings Motiva SmoothSilk Ergonomix and Motiva SmoothSilk Round breast implants for breast augmentation.
CDRH posts four dental final guidances under its Performance Criteria for Safety and Performance Based Pathway program.
FDA approves Sanofi and Regenerons Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive...
FDA approves Bristol-Myers Squibbs Cobenfy (xanomeline and trospium chloride) capsules for treating schizophrenia in adults.
