Siemens Healthcare Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Siemens Healthcare Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Atellica CH Diazo Total Bilirubin (D_TBil), Atellica® IM TSH3-Ultra II (TSH3ULII), Atellica IM Total PSA II (tPSAII)
152
Total
151
Cleared
1
Denied
Siemens Healthcare Diagnostics, Inc. has 151 FDA 510(k) cleared medical devices. Based in New York, US.
Latest FDA clearance: Feb 2026. Active since 2008. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Siemens Healthcare Diagnostics, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Siemens Healthcare Disgnostics, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Siemens Healthcare Diagnostics, Inc.
152 devices
Cleared
Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
Chemistry
245d
Cleared
Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
Chemistry
262d
Cleared
Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
Immunology
222d
Cleared
Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
Immunology
261d
Cleared
Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
Immunology
262d
Cleared
Jun 20, 2025
Atellica IM Thyroglobulin (Tg)
Immunology
267d
Cleared
Dec 04, 2024
Atellica® CH Creatinine_3 (Crea3)
Chemistry
89d
Cleared
Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Chemistry
35d
Cleared
Jul 25, 2024
Atellica® IM High-Sensitivity Troponin I (TnIH)
Chemistry
90d
Cleared
Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
Chemistry
192d
Cleared
Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Chemistry
112d
Cleared
Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
Chemistry
601d
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