| 2026-04-09 | K252228 | Seaman Pro/Seaman | Checkcells, Inc. | Hematology |
| 2026-02-06 | K243348 | Athelas Home | Athelas, Inc. | Hematology |
| 2025-06-27 | K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs , Ltd. | Hematology |
| 2025-05-30 | K242830 | LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer | Bonraybio Co., LTD. | Hematology |
| 2025-05-09 | K242388 | LensHooke X12 PRO Semen Analysis System | Bonraybio Co., LTD. | Hematology |
| 2024-05-03 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray Inc. | Hematology |
| 2023-09-19 | K221309 | AI100 with Shonit | SigTuple Technologies Pvt. Ltd. | Hematology |
| 2022-05-03 | K220013 | X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | Hematology |
| 2022-03-22 | K200828 | Athelas Home | Athelas Inc. | Hematology |
| 2020-10-28 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology |
| 2020-10-16 | K200595 | CellaVision DC-1, CellaVision DC-1 PPA | CellaVision AB | Hematology |
| 2020-10-02 | K201301 | X100 with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs LTD. | Hematology |
| 2019-11-01 | K190898 | Sight OLO | Sight Diagnostics Ltd. | Hematology |
| 2018-11-16 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | Hematology |
| 2018-11-05 | K181288 | Athelas One | Athelas Inc. | Hematology |
| 2017-08-01 | K171315 | Advanced RBC Application | Cella Vision AB | Hematology |
| 2013-03-22 | K120771 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | BECKMAN COULTER, INC. | Hematology |
| 2011-09-16 | K102778 | CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION | CELLAVISION AB | Hematology |
| 2010-05-12 | K092116 | EASYCELL CELL LOCATOR | MEDICA CORP. | Hematology |
| 2008-12-05 | K080595 | CELLAVISION DM96 WITH THE BODY FLUID APPLICATION | CELLAVISION AB | Hematology |
| 2004-02-10 | K033840 | CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER | CELLAVISION AB | Hematology |
| 2001-03-15 | K003301 | DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER | CELLAVISION AB | Hematology |