Siemens Healthineers AG is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Siemens Healthineers AG - FDA 510(k) Cleared Devices
Recent clearances: BIOGRAPH One, syngo.MR Applications (VB80), Syngo Carbon Clinicals (VA41)
4
Total
4
Cleared
0
Denied
Siemens Healthineers AG has 4 FDA 510(k) cleared medical devices. Based in Forchheim, DE.
Latest FDA clearance: Jun 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.
FDA 510(k) Regulatory Record - Siemens Healthineers AG
4 devices