Ewoosoft Co., Ltd. FDA Approvals

0 new drug approvals and 12 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
Clever One510(k)May 23, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 23, 2025
EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)510(k)Jul 23, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 23, 2024
Ez3D-i /E3510(k)Jul 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 14, 2023
EzDent Web510(k)Apr 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 21, 2023
EzDent-i / E2 / Prora View/ Smart M Viewer510(k)Feb 17, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 17, 2023
Ez3D-i/E3510(k)Sep 6, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2022
EzDent-i / E2 / Prora View/ Smart M Viewer510(k)Aug 12, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 12, 2022
EzOrtho v1.3510(k)Feb 23, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2022
EzDent-i/ E2/ Prora View/ Smart M Viewer510(k)Oct 4, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 4, 2021
EzDent Web510(k)Sep 28, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 28, 2021
EzOrtho510(k)Aug 23, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 23, 2021
Ez3D-i/E3510(k)Aug 20, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 20, 2021