Medical Device Manufacturer · CN , Suzhou

Realton (Suzhou) Medical Technology Co., Ltd. - FDA 510(k) Cleared De...

3 submissions · 3 cleared · Since 2020

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Realton (Suzhou) Medical Technology Co., Ltd. General & Plastic Surgery ✕

2 devices

1-2 of 2

Regulatory consultants 510(k) submission support ecosystem

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.

Guangzhou Osmunda Medical Device Technical Services Co., Ltd.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 23, 2026