| STA Satellite Max® (K253658) | Diagnostica Stago, Inc. | 2026-04-27 |
| Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965) | Sysmex America, Inc. | 2025-06-02 |
| TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024) | Haemonetics | 2025-04-30 |
| TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858) | Haemonetics Corporation | 2025-01-15 |
| Citrated: K, KH, RTH, FFH (K232018) | Haemonetics Corporation | 2024-03-29 |
| ACL TOP 970 CL (K233790) | Instrumentation Laboratory | 2023-12-29 |
| ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (K221359) | Instrumentation Laboratory CO | 2023-09-29 |
| STA R Max 3, STA Compact Max 3 (K212183) | Diagnostica Stago S.A.S | 2023-06-07 |
| ROTEM sigma Thromboelastometry System (K201440) | Tem Innovations GmbH | 2022-07-08 |
| 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 |
| Hemochron Signature Elite (K193041) | Accriva Diagnostics, Inc. | 2019-11-22 |
| QNext and DG-PT (K183390) | Diagnostic Grifols, S.A. | 2019-08-21 |
| TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (K183160) | Haemonetics Corporation | 2019-05-09 |
| CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (K173202) | Sekisui Medical Co., Ltd. | 2018-05-09 |
| Automated Blood Coagulation Analyzer CS-2500 (K172286) | Siemens Healthcare Diagnostic Products GmbH | 2017-12-18 |
| Sysmex CS-5100 (K172333) | Siemens Healthcare Diagnostics Products GmbH | 2017-10-31 |
| TEG 6s Hemostasis System (K160502) | Haemonetics Corporation | 2017-04-19 |
| ACL AcuStar (K170314) | Instrumentation Laboratory CO | 2017-03-03 |
| Sysmex CS-2100i (K162688) | Siemens Healthcare Diagnostics Products GmbH | 2016-12-26 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K162420) | Siemens Healthcare Diagnostics Products GmbH | 2016-12-12 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K161317) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-02 |
| Sysmex Automated Blood Coagulation Analyzer CS-2100i (K161312) | Siemens Healthcare Diagnostics Products GmbH | 2016-09-01 |
| Sysmex Automated Blood Coagulation Analyzer CS-2100i (K151259) | Siemens Healthcare Diagnostics Products GmbH | 2016-01-26 |
| Sysmex Automated Blood Coagulation Analyzer CS-5100 (K150678) | Siemens Healthcare Diagnostic Products GmbH | 2016-01-11 |
| STA R MAX (K151867) | Diagnostica Stago S.A.S | 2015-08-07 |
| CORA (Coagulation Resonance Analysis) System (K150041) | Coramed Technologies, LLC | 2015-06-26 |
| STA COMPACT MAX (K130090) | Diagnostica Stago, Incorporated | 2013-02-12 |
| EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K101533) | Tem Innovations GmbH | 2011-08-10 |
| ROTEM DELTA THROMBOELASTOMETRY SYSTEM (K083842) | Pentapharm GmbH | 2010-03-23 |
| STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K093167) | Diagnostica Stago, Inc. | 2009-12-22 |
| STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER (K093001) | Diagnostica Stago, Incorporated | 2009-12-18 |
| DESTINY MAX COAGULATION ANALYZER (K083896) | Trinity Biotech | 2009-07-02 |
| ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS (K083518) | Instrumentation Laboratory CO | 2009-03-13 |
| BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 (K083175) | Siemens Healthcare Diagnostics | 2009-01-26 |
| BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 (K083159) | Siemens Healthcare Diagnostics | 2009-01-26 |
| STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER (K082248) | Diagnostica Stago, Inc. | 2008-12-12 |
| STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER (K082675) | Diagnostica Stago, Inc. | 2008-10-10 |
| SMARTCHECK INR SYSTEM (K071265) | Inverness Medical Innovations, Inc. | 2007-11-30 |
| ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (K061014) | Helena Laboratories | 2006-05-10 |
| ACL ELITE; ACL ELITE PRO (K060162) | Instrumentation Laboratory CO | 2006-02-21 |
| COAG-A-MATE MTX III (K051030) | bioMerieux, Inc. | 2005-12-23 |
| HEMORAM/AGGRAM ANALYZER (K050053) | Helena Laboratories | 2005-07-11 |
| IMMEDIA PROTHROMBIN TIME SYSTEM (K050243) | Farallon Medial, Inc. | 2005-06-06 |
| MDA B.30 (K050513) | bioMerieux, Inc. | 2005-04-01 |
| HEMOCHRON SIGNATURE ELITE (K050016) | International Technidyne Corp. | 2005-02-10 |
| HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 (K040359) | Instrumentation Laboratory CO | 2004-03-19 |
| POTENS + (K033137) | Wada, Inc. | 2003-12-08 |
| HEMOCHRON RESPONSE/SYSTEM (K030818) | International Technidyne Corp. | 2003-04-02 |
| MODIFICATION TO STANDARD HUMAN PLASMA (K023141) | Dade Behring, Inc. | 2003-01-16 |
| AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED (K021162) | Sigma Diagnostics, Inc. | 2002-08-30 |
| HEMOCHRON JR. SIGNATURE + (K020798) | International Technidyne Corp. | 2002-03-28 |
| BCS SYSTEM (K013114) | Dade Behring, Inc. | 2001-11-09 |
| BCT SYSTEM (K011665) | Dade Behring, Inc. | 2001-08-09 |
| SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 (K011235) | Dade Behring, Inc. | 2001-07-20 |
| SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 (K010494) | Dade Behring, Inc. | 2001-05-01 |
| BEHRING COAGULATION SYSTEM, MODEL BCS (K002080) | Dade Behring, Inc. | 2000-11-16 |
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (K002177) | Haemoscope Corp. | 2000-09-14 |
| COAGUCHEK S SYSTEM, MODEL 2138280 (K994349) | Roche Diagnostics Corp. | 2000-09-06 |
| MODIFICATION OF ACL ADVANCE (K002400) | Instrumentation Laboratory CO | 2000-08-30 |
| BEHRING COAGULATION TIMER ANALYZER (BCT) (K001064) | Dade Behring, Inc. | 2000-06-21 |
| DADE BEHRING COAGULATION ANALYZER (BCT) (K001067) | Dade Behring, Inc. | 2000-06-20 |
| BEHRING COAGULATION SYSTEM (BCS) (K000973) | Dade Behring, Inc. | 2000-05-26 |
| THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES (K993678) | Haemoscope Corp. | 2000-05-05 |
| ACL 9000 SYSTEM (K000053) | Instrumentation Laboratory CO | 2000-03-15 |
| BEHRING COAGULATION SYSTEM (BCS) (K992959) | Dade Behring, Inc. | 2000-01-11 |
| DADE BEHRING BFTII (K984501) | Dade Behring, Inc. | 1999-07-28 |
| TAS ANALYZER, MODEL 1009 (K990566) | Cardiovascular Diagnostics, Inc. | 1999-05-14 |
| HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (K990449) | International Technidyne Corp. | 1999-04-13 |
| COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P (K983892) | Roche Diagnostics/Boehringer Mannheim GmbH | 1999-04-13 |
| STAR AUTOMATED MULTI-PARAMETRIC ANALYZER (K983460) | American Bioproducts Co. | 1998-11-12 |
| AVOCET PT (K980839) | Avocet Medical, Inc. | 1998-09-30 |
| SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 (K981711) | Dade Behring, Inc. | 1998-09-30 |
| HEPTRAC ELECTRONIC QUALITY CONTROL (K981815) | Medtronic Blood Management | 1998-07-30 |
| HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE (K974799) | International Technidyne Corp. | 1998-07-07 |
| COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569) | Boehringer Mannheim Corp. | 1998-01-09 |
| CS-400 COAGULATION ANALYZER SYSTEM (A1208) (K972260) | Sigma Diagnostics, Inc. | 1997-10-20 |
| BEHRING COAGULATION SYSTEM (K970431) | Behring Diagnostics, Inc. | 1997-05-05 |
| SYSMEX CA-1000/SYSMEX CA-5000 (K964946) | Sysmex Corp. | 1997-03-18 |
| THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 (K961908) | Helena Laboratories | 1996-12-10 |
| KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) (K960875) | Sigma Diagnostics, Inc. | 1996-09-10 |
| PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (K954202) | Medtronic Hemotec, Inc. | 1996-06-20 |
| AMAX CS-190 COAGULATION ANALYZER SYSTEM (K955720) | Sigma Diagnostics, Inc. | 1996-03-13 |
| KC 1A COAGULATION ANALYZER/SET (K955724) | Sigma Diagnostics, Inc. | 1996-03-12 |
| KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM (K955735) | Sigma Diagnostics, Inc. | 1996-03-11 |
| COAGUCHEK SYSTEM (K952625) | Boehringer Mannheim Corp. | 1995-11-21 |
| ACL FUTURA COAGULATION SYSTEM (K951891) | Instrumentation Laboratory CO | 1995-11-03 |
| SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER (K952560) | Sienco, Inc. | 1995-09-05 |
| CASCASE 480 SNSLYZER (K951497) | Helena Laboratories | 1995-09-01 |
| BEHRING FIBRINTIMER A (K926551) | Behring Diagnostics, Inc. | 1995-04-18 |
| TOA MEDICAL ELECTRONICS CA-1000 (K942096) | Sysmex Corp. | 1995-03-24 |
| TOA MEDICAL ELECTRONICS CA-5000 (K942097) | Sysmex Corp. | 1995-03-24 |
| HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM (K940957) | International Technidyne Corp. | 1994-10-18 |
| ACT CONTROL SET (K940840) | Sigma Diagnostics, Inc. | 1994-07-19 |
| JR. MICROCOAGULATION SYSTEM (K940401) | International Technidyne Corp. | 1994-05-11 |
| TOA MEDICAL ELECTRONICS CA-5000 (K933886) | Toa Medical Electronics USA, Inc. | 1994-01-27 |
| R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470 (K934747) | R & D Batteries, Inc. | 1993-12-03 |
| CA-1000 AUTOMATED COAGULATION ANALYZER (K931149) | Toa Medical Electronics USA, Inc. | 1993-11-03 |
| DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI (K933188) | Baxter Diagnostics, Inc. | 1993-09-22 |
| HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION (K930068) | Technidyne Corp. | 1993-09-02 |
| BOEHRINGER MANNHEIM COAGUCHEK SYSTEM (K930454) | Boehringer Mannheim Corp. | 1993-08-05 |