Cowellmedi Co., Ltd. FDA Approvals

0 new drug approvals and 7 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
SFIT Abutment510(k)Sep 16, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 16, 2025
INNO SLA Mini Plus® Implant System510(k)Dec 27, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 27, 2024
INNO SLA Submerged Hybrid Ti-Base System510(k)Dec 20, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
Meta G UCLA Abutment510(k)Nov 21, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 21, 2023
INNO SLA Submerged Narrow Implant System510(k)Oct 18, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 18, 2023
InnoGenic Non-resorbable Membrane510(k)Feb 24, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 24, 2023
INNO SLA Submerged Implant System510(k)Jan 25, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 25, 2022