Medical Device Manufacturer · SE , Linkoping

Amra Medical AB - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2018

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amra Medical AB Radiology ✕

2 devices

1-2 of 2

Cleared Nov 24, 2021

Radiology · 152d

Cleared Dec 06, 2018

Radiology · 363d

Data Source

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

Last updated: May 23, 2026