Medical Device Manufacturer · US , Nederland , CO

Shenzhen Med-Link Electronics Tech Co., Ltd. - FDA 510(k) Cleared Dev...

14 submissions · 14 cleared · Since 2009

Recent clearances: Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS), Disposable Non-invasive EEG Sensor, Med-link Disposable ECG Cable and Leadwires

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shenzhen Med-Link Electronics Tech Co., Ltd. General Hospital ✕

3 devices

1-3 of 3

Cleared Jan 08, 2026

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P,...

General Hospital · 268d

Cleared Aug 25, 2020

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

General Hospital · 267d

Cleared Jun 18, 2019

Med-link Temperature Probes

General Hospital · 266d