Siemens Healthcare Diagnostic Products GmbH FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
INNOVANCE® D-Dimer 2.0 (SMN 10873803)510(k)Aug 11, 2026Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Aug 11, 2026
INNOVANCE Antithrombin510(k)Mar 28, 2025Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Mar 28, 2025
CardioPhase® hsCRP510(k)Nov 27, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Nov 27, 2023