| XR-Series (XR-10, XR-20) Automated Hematology Analyzers (K253212) | Sysmex America, Inc. | 2026-05-27 |
| Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943) | Sysmex America, Inc. | 2025-06-25 |
| Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371) | Sysmex America, Inc. | 2025-06-25 |
| Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965) | Sysmex America, Inc. | 2025-06-02 |
| Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (K230887) | Sysmex America, Inc. | 2023-12-21 |
| Sysmex XW-100 Automated Hematology Analyzer (K210346) | Sysmex America, Inc. | 2022-11-08 |
| Sysmex XN-L Automated Hematology Analyzer (K182389) | Sysmex America, Inc. | 2019-01-25 |
| Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (K182062) | Sysmex America, Inc. | 2018-10-30 |
| Sysmex UF-5000 Fully Automated Urine Particle Analyzer (K171883) | Sysmex America, Inc. | 2018-04-23 |
| XW-100 Automated Hematology Analyzer for CLIA Waived Use (K172604) | Sysmex America, Inc. | 2017-11-06 |
| Sysmex XN-L Automated Hematology Analyzer (K160538) | Sysmex America, Inc. | 2016-12-22 |
| Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control (K160541) | Sysmex America, Inc. | 2016-10-21 |
| XW-100 Automated Hematology Analyzer, XW QC CHECK (K143577) | Sysmex America, Inc. | 2015-10-12 |
| SYSMEX XN SERIES (K141681) | Sysmex America, Inc. | 2014-12-05 |
| SYSMEX XN-SERIES (K112605) | Sysmex America, Inc. | 2012-10-19 |
| SYSMEX MODEL XT-4000I (K091313) | Sysmex America, Inc. | 2010-03-30 |
| SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (K083002) | Sysmex America, Inc. | 2009-02-03 |
| SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER (K081890) | Sysmex America, Inc. | 2008-10-10 |
| SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER (K081610) | Sysmex America, Inc. | 2008-08-29 |
| SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (K080887) | Sysmex America, Inc. | 2008-05-02 |
| SYSMEX XE-5000 (K071967) | Sysmex America, Inc. | 2007-11-20 |
| SYSMEX MODEL UF1000I (K070910) | Sysmex America, Inc. | 2007-05-25 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES (K061150) | Sysmex America, Inc. | 2006-07-06 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES (K060656) | Sysmex America, Inc. | 2006-05-10 |
| SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (K053135) | Sysmex America, Inc. | 2006-01-04 |
| SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER (K051459) | Sysmex America, Inc. | 2005-09-23 |
| IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K051199) | Sysmex America, Inc. | 2005-08-08 |
| RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K050589) | Sysmex America, Inc. | 2005-05-04 |
| SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) (K040073) | Sysmex America, Inc. | 2004-03-18 |
| SYSMEX POCH-100I (K032677) | Sysmex America, Inc. | 2004-02-11 |
| IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K032039) | Sysmex America, Inc. | 2003-09-08 |