Siemens Healthcare Diagnostics Products GmbH is one of 234 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Siemens Healthcare Diagnostics Products GmbH - FDA 510(k) Cleared Dev...
Recent clearances: INNOVANCE Anti-Xa (OPPU05), N Antisera to Human Immunoglobulins (IgG, IgA, and IgM), vWF Ag
19
Total
18
Cleared
1
Denied
Siemens Healthcare Diagnostics Products GmbH has 18 FDA 510(k) cleared medical devices. Based in Marburg, DE.
Latest FDA clearance: Oct 2024. Active since 2016. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Siemens Healthcare Diagnostics Products GmbH Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics Products GmbH
19 devices
Cleared
Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
Hematology
251d
Cleared
Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Immunology
28d
Cleared
Jun 02, 2023
vWF Ag
Hematology
445d
Cleared
Dec 16, 2022
CardioPhase® hsCRP
Chemistry
490d
Not Cleared
Sep 29, 2022
INNOVANCE VWF Ac
Hematology
701d
Cleared
Mar 02, 2022
N Latex FLC kappa, N Latex FLC lambda
Immunology
212d
Cleared
Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
Immunology
511d
Cleared
Jul 14, 2021
N Latex FLC kappa, N Latex FLC lambda
Immunology
621d
Cleared
May 03, 2019
N Latex FLC kappa, N Latex FLC lambda
Immunology
29d
Cleared
Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
Immunology
90d
Cleared
Sep 07, 2018
INNOVANCE Free PS Ag
Hematology
88d
Cleared
Nov 17, 2017
N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC...
Immunology
158d
Cleared
Oct 31, 2017
Sysmex CS-5100
Hematology
90d
Cleared
May 12, 2017
N Latex Cystatin C
Chemistry
32d
Cleared
Dec 26, 2016
Sysmex CS-2100i
Hematology
90d
Cleared
Dec 12, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
Hematology
104d
Cleared
Sep 02, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
Hematology
114d
Cleared
Sep 01, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
Hematology
114d
Cleared
Jan 26, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
Hematology
259d