Medical Device Manufacturer · CH , Lausanne

Smartcardia SA - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

2

Total

2

Cleared

0

Denied

FDA 510(k) cleared devices by Smartcardia SA Cardiovascular ✕

2 devices

1-2 of 2

Cleared Oct 31, 2024

SmartCardia 7L Platform (MCT)

Cardiovascular · 238d

Cleared Aug 30, 2023

SmartCardia 7L Platform

Cardiovascular · 120d

Data Source

Sourced from the FDA 510(k) public files . 5,396 total devices indexed.

Last updated: Mar 22, 2026