Siemens Healthcare Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL), ADVIA 2120i, ADVIA 2120, LOCI Total Vitamin D Total Assay, LOCI VITD CAL
92
Total
92
Cleared
0
Denied
Siemens Healthcare Diagnostics has 92 FDA 510(k) cleared medical devices. Based in Newark, US.
Latest FDA clearance: Apr 2025. Active since 2008. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Siemens Healthcare Diagnostics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics
92 devices
Cleared
Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
Chemistry
158d
Cleared
Aug 11, 2017
ADVIA 2120i, ADVIA 2120
Hematology
289d
Cleared
Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
Chemistry
212d
Cleared
Mar 09, 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-,...
Chemistry
234d
Cleared
Nov 17, 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI)...
Chemistry
66d
Cleared
Sep 30, 2016
Xprecia Stride Coagulation System, Xprecia System PT Controls
Hematology
442d
Cleared
Nov 04, 2015
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus...
Toxicology
282d
Cleared
Sep 18, 2015
Dimension Vista MMB Assay
Chemistry
263d
Cleared
Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista...
Chemistry
441d
Cleared
Apr 13, 2015
IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
Chemistry
82d
Cleared
Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
Immunology
32d
Cleared
Nov 17, 2014
CLINITEK NOVUS
Chemistry
242d
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