Natus Medical Incorporated - FDA 510(k) Cleared Devices

Natus Medical Incorporated, develops diagnostic and monitoring devices for neurological, sensory, and newborn care applications. The company operates with a manufacturing facility in Oakville, Ontario, Canada, and serves healthcare providers globally through neurodiagnostic and sensory screening solutions.

Natus Medical received 10 FDA 510(k) clearances from 10 total submissions between 2010 and 2018. The company's cleared devices span General Hospital, Neurology, Ear/Nose/Throat, and Ophthalmic categories, including phototherapy systems, hearing screeners, neurophysiology monitoring equipment, and retinal imaging devices. The company is currently inactive, with no FDA submissions recorded in the past five years.

Historical FDA 510(k) cleared products include LED phototherapy systems for neonatal jaundice, auditory brainstem response and otoacoustic emissions measurement systems, EEG monitoring devices, and retinal imaging technology. These devices reflect the company's focus on screening, diagnosis, and monitoring of brain, nerve, muscle, and sensory disorders.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database records below.