| i-STAT G3+ cartridge with the i-STAT 1 System (K223857) | Abbott Point of Care, Inc. | 2023-09-15 |
| i-STAT G cartridge with the i-STAT 1 System (K223755) | Abbott Point of Care, Inc. | 2023-09-11 |
| Minuteful-kidney test (K222921) | Healthy.Io, Ltd. | 2023-09-08 |
| ISE Electrodes (K230890) | Randox Laboratories, Ltd. | 2023-09-08 |
| VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197) | Ortho Clinical Diagnostics | 2023-09-05 |
| BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes (K213670) | Becton, Dickinson and Company | 2023-08-25 |
| Access Folate Assay (K223590) | Beckman Coulter, Inc. | 2023-08-23 |
| IDS ACTH II (K223867) | Immunodiagnostic Systems Limited | 2023-08-18 |
| BlueStar CGM insulin dose calculator (K222888) | Welldoc, Inc. | 2023-08-11 |
| GEM Premier 7000 with IQM3 (K223608) | Instrumentation Laboratory Company | 2023-08-10 |
| Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (K213131) | Roche Diabetes Care GmbH | 2023-08-10 |
| Accu-Chek Solo micropump system with interoperable technology (K213134) | Roche Diabetes Care GmbH | 2023-08-10 |
| ReliOn Premier BLU Blood Glucose Monitoring System (K230625) | I-Sens, Inc. | 2023-08-10 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K223710) | Abbott Point of Care, Inc. | 2023-07-28 |
| Quantisal™ II Oral Fluid Collection Device (K223781) | Immunalysis Corporation | 2023-07-28 |
| DEKA ACE Pump System (K213536) | Deka Research and Development | 2023-07-25 |
| A-LYTE® Integrated Multisensor (IMT Na K Cl) (K222438) | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 |
| Alkaline Phosphatase2 (K223317) | Abbott Ireland Diagnostics Division | 2023-07-21 |
| Elecsys proBNP II, Elecsys proBNP II STAT (K223637) | Roche Diagnostics | 2023-07-21 |
| ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (K220977) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-07-20 |
| AXINON® LDL-p Test System (K210801) | Numares AG | 2023-07-19 |
| BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes (K213953) | Becton, Dickinson and Company | 2023-07-17 |
| Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (K222116) | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 |
| Tandem Mobi Insulin Pump with Interoperable Technology (K223213) | Tandem Diabetes Care, Inc. | 2023-07-10 |
| Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood (K230080) | Yangzhou Medline Industry, Co., Ltd. | 2023-07-07 |
| Unistik® ShieldLock, Unistik VacuFlip (K223854) | Owen Mumford, Ltd. | 2023-06-30 |
| KidneyIntelX.dkd (DEN200052) | Renalytix Ai, Inc. | 2023-06-29 |
| MIO Blood Glucose Monitoring System (K223722) | Mio Labs, Inc. | 2023-06-28 |
| iLet® ACE Pump (K231485) | Beta Bionics, Inc. | 2023-06-21 |
| PAXgene® Blood DNA Tube (K231469) | Preanalytix GmbH | 2023-06-21 |
| Atellica® CH Diazo Direct Bilirubin (D_DBil) (K223078) | Siemens Healthcare Diagnostics, Inc. | 2023-06-12 |
| Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937) | Abbott Laboratories | 2023-06-05 |
| ADVIA Centaur® Anti-Müllerian Hormone (AMH) (K221801) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 |
| K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (K230408) | Sb-Kawasumi Laboratories, Inc. | 2023-06-01 |
| iLet® Dosing Decision Software (K220916) | Beta Bionics, Inc. | 2023-05-19 |
| Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790) | Abbott Laboratories | 2023-05-19 |
| iLet® ACE Pump (K223846) | Beta Bionics, Inc. | 2023-05-19 |
| B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (DEN220027) | Brahms GmbH, Part of Thermo Fisher Scientific | 2023-05-18 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System (K231081) | Dexcom, Inc. | 2023-05-15 |
| Alinity i STAT High Sensitivity Troponin-I (K230994) | Abbott Laboratories Diagnostics Division | 2023-05-04 |
| Kurin Blood Culture Collection Set with Kurin Lock Technology (K220677) | Kurin, Inc. | 2023-04-28 |
| AUTION MAX AX-4060 Urinalysis System (K193514) | Arkray, Inc. | 2023-04-13 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K223435) | Abbott Diabetes Care, Inc. | 2023-04-13 |
| Elecsys FT4 IV (K220456) | Roche Diagnostics | 2023-04-07 |
| Blood Collection Needle (with/without Needle Holder) (K223323) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-03-24 |
| BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder (K220212) | Becton, Dickinson and Company | 2023-03-24 |
| Atellica® CH Diazo Total Bilirubin (D_TBil) (K222104) | Siemens Healthcare Diagnostics, Inc. | 2023-03-20 |
| BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (K222478) | Becton, Dickinson and Company | 2023-03-10 |
| FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System (K222447) | Abbott Diabetes Care, Inc. | 2023-03-03 |
| Bigfoot Unity® Diabetes Management System (K222280) | Bigfoot Biomedical, Inc. | 2023-03-01 |
| MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) (K230038) | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-02-28 |
| Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K223810) | Sb-Kawasumi Laboratories, Inc. | 2023-02-24 |
| FreeStyle Libre 2 System, FreeStyle Libre 3 System (K223537) | Abbott Diabetes Care, Inc. | 2023-02-21 |
| Access Cortisol (K223038) | Beckman Coulter, Inc. | 2023-02-08 |
| Access AMH (K223679) | Beckman Coulter, Inc. | 2023-02-03 |
| GEM Premier ChemSTAT (K223090) | Instrumentation Laboratory CO | 2023-01-27 |
| Tacrolimus Assay Kit (K203833) | Shanghai Genext Medical Technology Co., Ltd. | 2023-01-27 |
| EasyStat 300 (K211559) | Medica Corporation | 2023-01-27 |
| Revogene (K222779) | Meridian Bioscience, Inc. | 2023-01-26 |
| Tidepool Loop (K203689) | Tidepool Project | 2023-01-23 |
| Access 25(OH) Vitamin D Total (K223503) | Beckman Coulter, Inc. | 2023-01-19 |
| Access Testosterone (K223405) | Beckman Coulter, Inc. | 2023-01-13 |
| Dexcom G6 Continuous Glucose Monitoring (CGM) System (K223931) | Dexcom, Inc. | 2023-01-11 |
| Total Bilirubin2 (K223324) | Abbott Ireland Diagnostics Division | 2022-12-29 |
| Access Total ßhCG (5th IS) (K221990) | Beckman Coulter, Inc. | 2022-12-27 |
| Access Vitamin B12 (K223289) | Beckman Coulter, Inc. | 2022-12-23 |
| GlucoSure ADVANCE Link Blood Glucose Monitoring System (K222234) | Apex BioTechnology Corp. | 2022-12-21 |
| Dexcom G7 Continuous Glucose Monitoring System (K213919) | Dexcom, Inc. | 2022-12-07 |
| MissLan™ Digital Pregnancy Rapid Test (K222305) | Guangzhou Decheng Biotechnology Co., Ltd. | 2022-11-30 |
| Steripath Micro Blood Collection System (K222299) | Magnolia Medical Technologies | 2022-11-30 |
| CONTOUR® NEXT GEN Blood Glucose Monitoring System (K223293) | Ascensia Diabetes Care U.S., Inc. | 2022-11-18 |
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |
| BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System (K220421) | Apex BioTechnology Corp. | 2022-11-04 |
| ORAcollect®•Dx (K212745) | DNA Genotek, Inc. | 2022-10-27 |
| Eclipse Blood Collection Set (K213690) | Eclipse Medcorp, LLC | 2022-10-26 |
| Safety Blood Collection Needle (Without Needle Holder) (K222141) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-10-21 |
| Nova Primary Glucose Analyzer System (K203549) | Nova Biomedical Corporation | 2022-10-18 |
| SuperCheck Pro Blood Glucose Monitoring System (K213061) | Ok Biotech Co., Ltd. | 2022-10-07 |
| Velano Vascular Blood Collection Adapter (K201237) | Velano Vascular | 2022-10-03 |
| Clearblue ® Early Pregnancy Test (K213379) | Spd Swiss Precision Diagnostics GmbH | 2022-09-21 |
| cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (K220134) | Roche Diagnostics | 2022-09-16 |
| SOL-GUARD Safety Pull Button Collection Set (K213718) | Sol-Millennium Medical, Inc. | 2022-08-30 |
| GlucoLeader Enhance 2 Blood Glucose Monitoring System (K212248) | Hmd Biomedical, Inc. | 2022-08-29 |
| K-SHIELD Zen (K220799) | Sb-Kawasumi Laboratories, Inc. | 2022-08-29 |
| GlucoSure Link Blood Glucose Monitoring System (K212140) | Apex BioTechnology Corp. | 2022-08-25 |
| SmartAdjust(TM) technology (K220394) | Insulet Corporation | 2022-08-19 |
| SmartBolus Calculator (K222239) | Insulet Corporation | 2022-08-19 |
| Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System (K202739) | Bioland Technology, Ltd. | 2022-08-12 |
| Safety Blood Collection Needles with/without Needle Holder (K220900) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-08-10 |
| Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System (K221259) | Dexcom, Inc. | 2022-07-29 |
| 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) (K220258) | Avia Vascular | 2022-07-14 |
| Revogene (K220480) | Meridian Bioscience, Inc. | 2022-07-11 |
| VIDAS NEPHROCHECK (K210793) | Biomérieux SA | 2022-07-08 |
| Minuteful - kidney test (K210069) | Healthy.Io, Ltd. | 2022-07-06 |
| Cholesterol2 (K203597) | Abbott Ireland Diagnostics Division | 2022-06-30 |
| hCG One Step Pregnancy Test (K212418) | Healstone Biotech, Inc. | 2022-06-30 |
| FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (K201037) | Taidoc Technology Corporation | 2022-06-16 |
| Elecsys AMH (K203757) | Roche Diagnostics | 2022-06-10 |
| Urea Nitrogen2 (K203771) | Abbott Ireland Diagnostics Division | 2022-05-31 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System (K212132) | Abbott Diabetes Care, Inc. | 2022-05-26 |