| OptraSCAN System (K260755) | Optrascan, Inc. | 2026-07-02 |
| Blood Volume Analyzer (200) (K261099) | Daxor Corporation | 2026-06-18 |
| XR-Series (XR-10, XR-20) Automated Hematology Analyzers (K253212) | Sysmex America, Inc. | 2026-05-27 |
| STA Satellite Max® (K253658) | Diagnostica Stago, Inc. | 2026-04-27 |
| Seaman Pro/Seaman (K252228) | Checkcells, Inc. | 2026-04-09 |
| HemosIL Factor V Leiden (APC Resistance V) (K260551) | Instrumentation Laboratory (IL) Co. | 2026-03-20 |
| Athelas Home (K243348) | Athelas, Inc. | 2026-02-06 |
| Tru Hematology Test (K251249) | Truvian Sciences, Inc. | 2026-01-16 |
| HemosIL Silica Clotting Time (K253957) | Instrumentation Laboratory (IL) Co. | 2026-01-09 |
| CoaguChek XS Plus System (K253188) | Roche Diagnostics | 2025-10-24 |
| KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) (DEN240067) | Cytocell Limited | 2025-09-19 |
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Quantra QStat Cartridge (K251404) | Hemosonics, LLC | 2025-08-25 |
| CRYOcheck Chromogenic Factor VIII (K251440) | Precision Biologic, Inc. | 2025-08-25 |
| Blood Volume Analyzer (200) (K251087) | Daxor Corporation | 2025-08-04 |
| HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL (K251968) | Instrumentation Laboratory (IL) Co. | 2025-07-24 |
| microINR System (K251564) | Iline Microsystems, S.L. | 2025-07-21 |
| X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144) | Scopio Labs , Ltd. | 2025-06-27 |
| 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 |
| LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830) | Bonraybio Co., Ltd. | 2025-05-30 |
| ConcizuTrace™ ELISA (DEN240035) | Randox Laboratories, Ltd. | 2025-05-22 |
| LensHooke X12 PRO Semen Analysis System (K242388) | Bonraybio Co., Ltd. | 2025-05-09 |
| SQA-iOw Sperm Quality Analyzer (K243114) | Medical Electronic Systems , Ltd. | 2025-05-02 |
| TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024) | Haemonetics | 2025-04-30 |
| INNOVANCE Antithrombin (K242952) | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 |
| microINR System (K243543) | Iline Microsystems, S.L. | 2025-02-27 |
| Xpert® FII & FV (K250218) | Cepheid | 2025-02-21 |
| Alinity h-series System (K243283) | Abbott Laboratories | 2025-02-20 |
| Cito CBC System (K240402) | Cytochip, Inc. | 2025-02-03 |
| HemosIL CL HIT-IgG(PF4-H) (K243374) | Instrumentation Laboratory (IL) Co. | 2025-01-28 |
| TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858) | Haemonetics Corporation | 2025-01-15 |
| VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) (DEN240025) | Ventana Medical Systems, Inc. | 2024-12-05 |
| YO Home Sperm Test (K241628) | Medical Electronic Systems , Ltd. | 2024-11-29 |
| Nova Allegro HbA1c Assay, Nova Allegro Analyzer (K221326) | Nova Biomedical Corporation | 2024-11-22 |
| INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (K240315) | Siemens Healthcare Diagnostics Products GmbH | 2024-10-10 |
| ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) (K242127) | Instrumentation Laboratory (IL) Co. | 2024-08-16 |
| UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (K240252) | Beckman Coulter, Inc. | 2024-07-05 |
| Yumizen H2500 (K232946) | HORIBA ABX SAS | 2024-05-21 |
| AUTION EYE AI-4510 Urine Particle Analysis System (K232416) | Arkray, Inc. | 2024-05-03 |
| HemoScreen Hematology Analyzer (K240636) | Pixcell Medical Technologies | 2024-05-02 |
| UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (K232317) | Urit Medical Electronic Co., Ltd. | 2024-04-26 |
| Access EPO (K240182) | Beckman Coulter, Inc. | 2024-04-22 |
| CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (K232027) | Sebia | 2024-04-04 |
| Citrated: K, KH, RTH, FFH (K232018) | Haemonetics Corporation | 2024-03-29 |
| QStat Cartridge (K240045) | Hemosonics, LLC | 2024-03-27 |
| X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application (DEN230034) | Scopio Labs , Ltd. | 2024-03-22 |
| Xprecia Prime Coagulation System (K230802) | Universal Biosensors Pty, Ltd. | 2024-03-15 |
| Technozym ADAMTS13 Activity (DEN230024) | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | 2024-02-28 |
| ACL TOP 970 CL (K233790) | Instrumentation Laboratory | 2023-12-29 |
| Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer (K230887) | Sysmex America, Inc. | 2023-12-21 |
| HemosIL Chromogenic Factor IX (K230852) | Instrumentation Laboratory Company | 2023-12-13 |
| Q-Pad Test System (K231465) | Qurasense | 2023-12-06 |
| DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600) | Beckman Coulter, Inc. | 2023-11-22 |
| QScout Lab; QScout RLD (K230878) | Ad Astra Diagnostics, Inc. | 2023-11-14 |
| AnemoCheck Home (K221508) | Sanguina, Inc. | 2023-09-29 |
| ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (K221359) | Instrumentation Laboratory CO | 2023-09-29 |
| Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (K214117) | Abbott Diagnostics Technologies AS | 2023-09-27 |
| AI100 with Shonit (K221309) | Sigtuple Technologies Pvt. , Ltd. | 2023-09-19 |
| CRYOcheck Factor VIII Deficient Plasma with VWF (K222831) | Precision Biologic, Inc. | 2023-09-13 |
| Quantra Hemostasis Analyzer (K232215) | Hemosonics, LLC | 2023-08-24 |
| HemoScreen Hematology Analyzer (K222148) | Pixcell Medical Technologies, Ltd. | 2023-08-16 |
| SQA-iO Sperm Quality Analyzer (K220828) | Medical Electronic Systems , Ltd. | 2023-08-07 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |
| Premier Resolution System (K222635) | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023-08-04 |
| i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) | Abbott Laboratories | 2023-07-14 |
| microINR System (K231711) | Iline Microsystems, S.L. | 2023-07-11 |
| HemosIL Liquid Anti-Xa (K223187) | Instrumentation Laboratory CO | 2023-06-23 |
| ACL TOP Family 70 Series (K231031) | Instrumentation Laboratory Company | 2023-06-21 |
| Healgen URS Test Strips (K231045) | Healgen Scientific,, LLC | 2023-06-16 |
| STA R Max 3, STA Compact Max 3 (K212183) | Diagnostica Stago S.A.S | 2023-06-07 |
| vWF Ag (K220728) | Siemens Healthcare Diagnostics Products GmbH | 2023-06-02 |
| Quantra Hemostasis Analyzer (K230461) | Hemosonics, LLC | 2023-03-24 |
| Xpert® FII & FV (K223046) | Cepheid® | 2023-02-15 |
| Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (K223635) | Sienco, Inc. | 2023-01-04 |
| CRYOcheck Chromogenic Factor IX (K214002) | Precision Biologic, Inc. | 2022-12-23 |
| STA- NeoPTimal (K211485) | Diagnostica Stago S.A.S | 2022-12-23 |
| Quantra QPlus System (K223433) | Hemosonics, LLC | 2022-12-13 |
| HemosIL von Willebrand Factor Antigen (K223402) | Instrumentation Laboratory CO | 2022-12-09 |
| QStat Cartridge (K213917) | Hemosonics, LLC | 2022-11-29 |
| Sysmex XW-100 Automated Hematology Analyzer (K210346) | Sysmex America, Inc. | 2022-11-08 |
| Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779) | Coagusense, Inc. | 2022-10-05 |
| HemosIL Liquid Anti-Xa (K213464) | Instrumentation Laboratory CO | 2022-10-04 |
| INNOVANCE VWF Ac (DEN200067) | Siemens Healthcare Diagnostics Products GmbH | 2022-09-29 |
| FINDER G6PD (K201049) | Baebies, Inc. | 2022-09-14 |
| HemosIL ReadiPlasTin (K213426) | Instrumentation Laboratory CO | 2022-08-16 |
| Her-2, ER, PR IHControls (K220163) | Boston Cell Standards, Inc. | 2022-08-15 |
| ROTEM sigma Thromboelastometry System (K201440) | Tem Innovations GmbH | 2022-07-08 |
| Hemosure Accu-Reader A100 (K200754) | W.H.P.M., Inc. | 2022-06-02 |
| Sight OLO (K211840) | S.D. Sight Diagnostics , Ltd. | 2022-05-09 |
| X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (K220013) | Scopio Labs , Ltd. | 2022-05-03 |
| V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (K192931) | Helena Laboratories, Corp. | 2022-04-19 |
| Athelas Home (K200828) | Athelas, Inc. | 2022-03-22 |
| GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 (K202101) | Accriva Diagnostics, Inc. | 2021-12-29 |
| iQ200 System, iChemVELOCITY Automated Urine Chemistry System (K210127) | Beckman Coulter, Inc. | 2021-07-02 |
| microINR System (K201185) | Iline Microsystems, S.L. | 2020-12-18 |
| cobas u 701 microscopy analyzer (K200811) | Roche Diagnostics | 2020-11-06 |
| LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer (K202089) | Bonraybio Co., Ltd. | 2020-10-28 |
| Cryocheck Hex LA (K193556) | Precision Biologic | 2020-10-23 |