Siemens Healthineers AG
Siemens Healthineers AG appears in FDA public data with 0 recalls, 7 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 31, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 9
- Compliance Actions
- 0
Known Names
siemens-healthineers, siemens-healthineers-international, 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-healthcare-diagnostics
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | July 31, 2026 |
| K253690 | LungMaps | June 15, 2026 |
| K253023 | BIOGRAPH One | January 15, 2026 |
| K253495 | syngo.MR Applications (VB80) | November 20, 2025 |
| K251059 | Syngo Carbon Clinicals (VA41) | October 24, 2025 |
| K241898 | Symbia SPECT and SPECT/CT Systems | July 26, 2024 |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | March 20, 2019 |