Guangdong Horigen Mother & Baby Products 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
Wearable breast pump (Model: XN/MD-2249BS, ZFHF)510(k)Sep 1, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Sep 1, 2026
Electric Breast Pump510(k)May 6, 2022Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	May 6, 2022
Electric Breast Pump510(k)May 4, 2021Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	May 4, 2021
Single-use medical face mask510(k)Mar 7, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 7, 2021