Siemens Healthcare Diagnostic Products GmbH is one of 470 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Siemens Healthcare Diagnostic Products GmbH - FDA 510(k) Cleared Devi...
Recent clearances: INNOVANCE® D-Dimer 2.0 (SMN 10873803), INNOVANCE Antithrombin, CardioPhase® hsCRP
5
Total
5
Cleared
0
Denied
Siemens Healthcare Diagnostic Products GmbH has 5 FDA 510(k) cleared medical devices. Based in Marburg, DE.
Latest FDA clearance: Aug 2026. Active since 2016. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Siemens Healthcare Diagnostic Products GmbH Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Siemens Healthcare Disgnostics Products GmbH as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostic Products GmbH
5 devices
Cleared
Aug 11, 2026
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
Hematology
242d
Cleared
CT
Mar 28, 2025
INNOVANCE Antithrombin
Hematology
184d
Cleared
Nov 27, 2023
CardioPhase® hsCRP
Immunology
90d
Cleared
Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
Hematology
143d
Cleared
Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
Hematology
301d