FDA clears ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube in three sizes.
FDA and commissioner Robert Califf launch a new 'Rumor Control' Web page as part of the agency's first effort to address misinformation.
FDA warns Natick, MA-based Zyno Medical about Quality System and other violations in its production of infusion pumps and administration sets.
FDA clears a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart function and fluid status ...
FDA sends CorMedix a second complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure p...
FDA warns West Sacramento, CA-based Valley Biosystems about violations in its conduct of two nonclinical laboratory studies.
FDA warns Natick, MA-based Infutronix about Quality System and Medical Device Reporting violations in its production of infusion pumps and administrat...
FDA issues Bavarian Nordic an emergency use authorization for its smallpox/monkeypox vaccine Jynneos to allow healthcare providers to use administer i...
