Disior, Ltd. FDA Approvals

0 new drug approvals and 6 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
ENOS Software Guided External Fixation System510(k)Feb 26, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 26, 2026
SMART PCFD510(k)Sep 29, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 29, 2025
SMART Bun-Yo-Matic X-Ray510(k)Jul 2, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 2, 2024
SMART Bun-Yo-Matic CT510(k)Jun 20, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 20, 2024
Bonelogic510(k)Dec 8, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
Bonelogic510(k)Feb 5, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 5, 2021