Guangdong Transtek Medical Electronics Co., Ltd. FDA Approvals

0 new drug approvals and 11 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
TeleRPM Gen2 Blood Glucose Monitoring System510(k)Jan 30, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 30, 2025
Blood Pressure Monitor (TMB-2092-G)510(k)Aug 21, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Aug 21, 2024
Blood Pressure Monitor (BBZ32-AA01)510(k)Jun 7, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 7, 2024
Blood Pressure Monitor (TMB-2296-BT)510(k)May 31, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 31, 2024
Blood Pressure Monitor (TMB-2287-B)510(k)Apr 29, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 29, 2024
Blood Pressure Monitor510(k)Dec 20, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
Blood Pressure Monitor510(k)Nov 28, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 28, 2023
Blood pressure monitor510(k)Nov 22, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2023
Blood Pressure Monitor510(k)Jun 30, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 30, 2023
Blood Pressure Monitor510(k)Aug 29, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 29, 2022
Blood Pressure Monitor510(k)Mar 9, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 9, 2021