ClearanceBrief
Company ยท CN

Guangdong Transtek Medical Electronics Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2025. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DXNSystem, Measurement, Blood-Pressure, Non-Invasive14
MNWAnalyzer, Body Composition2
NBWSystem, Test, Blood Glucose, Over The Counter1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 30, 2025K243060TeleRPM Gen2 Blood Glucose Monitoring System
Guangdong Transtek Medical Electronics Co., Ltd., CN
NBW
Aug 21, 2024K241351Blood Pressure Monitor (TMB-2092-G)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Jun 7, 2024K240832Blood Pressure Monitor (BBZ32-AA01)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
May 31, 2024K240254Blood Pressure Monitor (TMB-2296-BT)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Apr 29, 2024K240102Blood Pressure Monitor (TMB-2287-B)
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Dec 20, 2023K233130Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Nov 28, 2023K232713Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Nov 22, 2023K232621Blood pressure monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Jun 30, 2023K223374Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Aug 29, 2022K220676Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Mar 9, 2021K202891Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Dec 6, 2020K202599Transtek Wrist Blood Pressure Monitor
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Apr 9, 2019K181832Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Oct 14, 2016K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure De
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
Sep 18, 2013K131394TRANSTEK GLASS BODY FAT ANALYZER
Guangdong Transtek Medical Electronics Co., Ltd., CN
MNW
Jun 19, 2013K131395TRANSTEK BLOOD PRESSURE MONITOR
Guangdong Transtek Medical Electronics Co., Ltd., CN
DXN
May 30, 2013K130311TRANSTEK BODY FAT ANALYZER
Guangdong Transtek Medical Electronics Co., Ltd., CN
MNW

Latest recalls

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