Siemens Healthcare Diagnostic Products GmbH

FDA Regulatory Profile

Siemens Healthcare Diagnostic Products GmbH appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 11, 2026.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)August 11, 2026
K242952INNOVANCE AntithrombinMarch 28, 2025
K232624CardioPhase® hsCRPNovember 27, 2023
K172286Automated Blood Coagulation Analyzer CS-2500December 18, 2017
K150678Sysmex Automated Blood Coagulation Analyzer CS-5100January 11, 2016