Smart Soft Healthcare AD FDA Approvals

0 new drug approvals and 3 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
CoLumbo C-Spine510(k)Apr 1, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 1, 2026
CoLumboX510(k)May 28, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 28, 2025
CoLumbo510(k)Jun 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 23, 2022