Clarius Mobile Health Corp. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Clarius Ejection Fraction AI510(k)Mar 2, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 2, 2026
Clarius Median Nerve AI510(k)May 8, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 8, 2025
Clarius Prostate AI510(k)Apr 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2025
Clarius OB AI510(k)Jun 14, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2024
Clarius Bladder AI510(k)Nov 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 13, 2023
Clarius Ultrasound Scanner510(k)Oct 5, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 5, 2023
Clarius AI510(k)Jan 23, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 23, 2023
Clarius Ultrasound Scanner510(k)Nov 15, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Nov 15, 2021