Sysmex America, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sysmex America, Inc. - FDA 510(k) Cleared Devices
Recent clearances: XR-Series (XR-10, XR-20) Automated Hematology Analyzers, Sysmex XR-Series (XR-10) Automated Hematology Analyzer, Sysmex XR-Series (XR-20) Automated Hematology Analyzer
31
Total
31
Cleared
0
Denied
Sysmex America, Inc. has 31 FDA 510(k) cleared hematology devices. Based in Mundelein, US.
Latest FDA clearance: May 2026. Active since 2003.
Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sysmex America, Inc.
31 devices
Cleared
May 27, 2026
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
Hematology
240d
Cleared
Jun 25, 2025
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
Hematology
89d
Cleared
Jun 25, 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
Hematology
54d
Cleared
Jun 02, 2025
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
Hematology
63d
Cleared
Dec 21, 2023
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
Hematology
265d
Cleared
Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
Hematology
638d
Cleared
Jan 25, 2019
Sysmex XN-L Automated Hematology Analyzer
Hematology
143d
Cleared
Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Hematology
90d
Cleared
Apr 23, 2018
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
Hematology
304d
Cleared
Nov 06, 2017
XW-100 Automated Hematology Analyzer for CLIA Waived Use
Hematology
68d
Cleared
Dec 22, 2016
Sysmex XN-L Automated Hematology Analyzer
Hematology
300d
Cleared
Oct 21, 2016
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH...
Chemistry
238d