Medical Device Manufacturer · DE , Forchheim

Siemens Healthineers AG - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2025

Total

Cleared

Denied

Siemens Healthineers AG has 6 FDA 510(k) cleared medical devices. Based in Forchheim, DE.

Latest FDA clearance: Sep 2026. Active since 2025. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Siemens Healthineers AG Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Siemens Medical Solutions USA, Inc. and Regulatory Technology Services, LLC.

Siemens Healthineers AG is one of 467 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Siemens Healthineers AG

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Oct 05, 2026