H&abyz Co., Ltd. FDA Approvals

0 new drug approvals and 4 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
HnX-P1, HnX-PB510(k)Aug 4, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 4, 2025
A1417MCW/A1717MCW/F1417MCW510(k)Mar 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 6, 2023
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)510(k)Nov 15, 2021Radiology	Radiology	510(k)Substantially Equivalent (Special)	Nov 15, 2021
ADD510(k)Mar 12, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 12, 2021