Siemens Healthineers

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
9
Compliance Actions
0

Known Names

siemens healthcare diagnostics, siemens-healthineers, siemens medical systems, corindus vascular robotics, siemens healthineers international, siemens medical solutions diagnostics, varian medical systems international, varian medical systems particle therapy, siemens medical instruments, siemens-healthineers-international

Recent 510(k) Clearances

K-NumberDeviceDate
K253023BIOGRAPH OneJanuary 15, 2026
K253495syngo.MR Applications (VB80)November 20, 2025
K251059Syngo Carbon Clinicals (VA41)October 24, 2025
K241898Symbia SPECT and SPECT/CT SystemsJuly 26, 2024
K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemMarch 20, 2019