| TRUE METRIX Self Monitoring Blood Glucose System (K262116) | Trividia Health, Inc. | 2026-07-23 |
| SmartGuard Technology; Predictive Low Glucose Technology (K261962) | Medtronic MiniMed | 2026-07-09 |
| Omnipod 6 algorithm (K261461) | Insulet Corporation | 2026-06-29 |
| i-STAT Crea cartridge with the i-STAT 1 System (K261039) | Abbott Point of Care, Inc. | 2026-06-26 |
| twiist Automated Insulin Delivery (AID) System (K261672) | Deka Research and Development | 2026-06-17 |
| cobas pulse blood glucose monitoring system (K252323) | Roche Diagnostics | 2026-06-12 |
| Stelo Glucose Biosensor System (K260935) | Dexcom, Inc. | 2026-06-12 |
| i-STAT hs-TnI cartridge with the i-STAT Alinity System (K253051) | Abbott Point of Care, Inc. | 2026-06-11 |
| Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (K261402) | Dexcom, Inc. | 2026-06-08 |
| Female Culture Device; Male Culture Device; Transfer Device; Access Device (K252899) | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 |
| Stelo Glucose Biosensor System (K261359) | Dexcom, Inc. | 2026-05-21 |
| ABL90 FLEX PLUS System (K252488) | Radiometer Medicals Aps | 2026-05-01 |
| ABL90 FLEX PLUS System (K252475) | Radiometer Medicals Aps | 2026-05-01 |
| iLet ACE Pump (K253976) | Beta Bionics, Inc. | 2026-04-30 |
| Elecsys Calcitonin (K252431) | Roche Diagnostics GmbH | 2026-04-24 |
| Control-IQ+ technology (K260429) | Tandem Diabetes Care, Inc. | 2026-04-24 |
| IDS-iSYS Total Testosterone (K252728) | Immunodiagnostic Systems Limited | 2026-04-15 |
| BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (K260128) | Becton, Dickinson and Company | 2026-04-15 |
| BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube (K252378) | Becton, Dickinson and Company | 2026-04-10 |
| ABL90 FLEX PLUS System, safeCLINITUBES (K252207) | Radiometer Medicals Aps | 2026-04-10 |
| BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder (K252506) | Becton, Dickinson and Company | 2026-04-10 |
| SMART M-CELL Bone Marrow Concentration System (K250518) | Miracell Co., Ltd. | 2026-04-02 |
| SMART M-CELL PRP Concentration System (K250516) | Miracell Co., Ltd. | 2026-04-02 |
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
| BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes (K252040) | Becton, Dickinson and Company | 2026-03-13 |
| MiniMed Flex pump (K253743) | Medtronic Minimed, Inc. | 2026-03-12 |
| Atellica CH Diazo Total Bilirubin (D_TBil) (K251998) | Siemens Healthcare Diagnostics, Inc. | 2026-02-27 |
| QSCHECK UISACR (K252619) | Qstag, Inc. | 2026-02-20 |
| Alere NT-proBNP for Alinity i (K253539) | Axis-Shield Diagnostics, Ltd. | 2026-02-18 |
| Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490) | Roche Diagnostics | 2026-02-12 |
| ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491) | Roche Diagnostics | 2026-02-12 |
| Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 |
| SmartGuard Technology; Predictive Low Glucose Technology (K253701) | Medtronic Minimed | 2026-02-03 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253737) | Dexcom, Inc. | 2026-02-03 |
| Nova Max Creat eGFR Monitoring System (K251281) | Nova Biomedical Corporation | 2026-01-21 |
| MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (K253470) | Medtronic Minimed, Inc. | 2026-01-15 |
| SmartGuard technology; Predictive Low Glucose technology (K253585) | Medtronic Minimed, Inc. | 2026-01-14 |
| Nova Allegro UACR Assay, Nova Allegro Analyzer (K252206) | Nova Biomedical Corporation | 2026-01-09 |
| Core Metabolic (K251157) | Truvian Health | 2026-01-09 |
| Medconn 8K Glycated Hemoglobin Test System (K252749) | Shanghai Medconn Medical Technology Co., Ltd. | 2026-01-06 |
| Lipids (K251091) | Truvian Health | 2025-12-30 |
| Healgen® URS Test Strips (K251800) | Healgen Scientific,, LLC | 2025-12-23 |
| DBLG2 (K251152) | Diabeloop | 2025-12-19 |
| Tru Liver Health Test Panel (K251074) | Truvian Health | 2025-12-19 |
| Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (K253710) | Dexcom, Inc. | 2025-12-17 |
| Omnipod 5 algorithm (K251779) | Insulet Corporation | 2025-12-03 |
| Tru Kidney Health Test Panel; Tru Analyzer (K251058) | Truvian Health | 2025-11-26 |
| Dexcom Smart Basal (K252818) | Dexcom, Inc. | 2025-11-18 |
| Tandem Mobi insulin pump with interoperable technology (K253074) | Tandem Diabetes Care, Inc. | 2025-11-06 |
| AllTest Urinary Tract Infection Test (K252607) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393) | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 |
| Glucose2 (K252357) | Abbott Ireland | 2025-10-24 |
| On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System (K250085) | ACON Laboratories, Inc. | 2025-10-10 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (K250073) | Tosoh Bioscience, Inc. | 2025-10-03 |
| iLet ACE Pump (K252770) | Beta Bionics, Inc. | 2025-09-29 |
| Steripath® Flow™ Blood Collection System (K251812) | Magnolia Medical Technologies | 2025-09-25 |
| t:slim X2 insulin pump with interoperable technology (K250792) | Tandem Diabetes Care, Inc. | 2025-09-24 |
| Biolinq Shine Autonomous Time-in-Range Microsensor (DEN240080) | Biolinq Incorporated | 2025-09-23 |
| MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (K251040) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 |
| SmartGuard technology; Predictive Low Glucose technology (K251217) | Medtronic Minimed, Inc. | 2025-08-29 |
| Origin™ (K243965) | Nerv Technology Inc. (D.B.A.) Fluidai Medical | 2025-08-21 |
| Access hsTnI (K243483) | Beckman Coulter, Inc. | 2025-08-01 |
| Elecsys Cortisol III (K242505) | Roche Diagnostics | 2025-07-17 |
| Shinetell PlusTM Digital Early Pregnancy Test (K251053) | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 |
| BD Vacutainer® Eclipse™ Blood Collection Needle (K243207) | Becton, Dickinson and Company | 2025-07-03 |
| MiniMed 780G insulin pump (K251032) | Medtronic Minimed, Inc. | 2025-07-01 |
| Medconn Glycated Hemoglobin Test system (K242911) | Shanghai Medconn Medical Technology Co., Ltd. | 2025-06-20 |
| Access hsTnI (K242870) | Beckman Coulter, Inc. | 2025-06-16 |
| Blood collection tube holders (K250961) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 |
| Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (K244047) | Venocare, Inc. | 2025-05-23 |
| Control-IQ+ technology (K250798) | Tandem Diabetes Care, Inc. | 2025-05-21 |
| Cystatin C (K242585) | SENTINEL CH. SpA | 2025-05-16 |
| i-STAT CG4+ cartridge with the i-STAT 1 System (K244014) | Abbott Point of Care, Inc. | 2025-05-02 |
| Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (K250907) | Sol-Millennium Medical, Inc. | 2025-04-30 |
| Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (K243570) | Siemens Healthcare Diagnostics | 2025-04-25 |
| Dexcom G7 15 Day Continuous Glucose Monitoring System (K243214) | Dexcom, Inc. | 2025-04-09 |
| UASure II Blood Uric Acid Monitoring System (K242209) | Apex BioTechnology Corp. | 2025-04-04 |
| twiist system (K250930) | Deka Research & Development Corp. | 2025-04-02 |
| BD Vacutainer® Multiple Sample Luer Adapter (K243649) | Becton, Dickinson and Company | 2025-03-21 |
| Signos Glucose Monitoring System (K250106) | Signos, Inc. | 2025-03-21 |
| Revogene (K243922) | Meridian Bioscience, Inc. | 2025-03-20 |
| Access Cortisol; DxC 500i Clinical Analyzer (K242190) | Beckman Coulter, Inc. | 2025-03-05 |
| PIVO™ Pro Needle-free Blood Collection Device (K241586) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 |
| Control-IQ+ technology (K243823) | Tandem Diabetes Care, Inc. | 2025-02-24 |
| FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (K250117) | Assure Tech., LLC | 2025-02-13 |
| Calcium2 (K244042) | Abbott Ireland | 2025-02-10 |
| Elecsys sFlt-1 and Elecsys PlGF (K241453) | Roche Diagnostics | 2025-02-07 |
| Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135) | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 |
| TeleRPM Gen2 Blood Glucose Monitoring System (K243060) | Guangdong Transtek Medical Electronics Co., Ltd. | 2025-01-30 |
| Alere NT-proBNP for Alinity i Reagent Kit (K241176) | Axis-Shield Diagnostics, Ltd. | 2025-01-16 |
| FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (K243573) | Assure Tech., LLC | 2025-01-15 |
| ABL90 FLEX PLUS System (K241037) | Radiometer Medicals Aps | 2025-01-14 |
| Safecare Urinary Tract Infection Test (K242767) | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-01-10 |
| i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984) | Abbott Point of Care, Inc. | 2025-01-03 |
| iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394) | Andon Health Co, Ltd. | 2024-12-20 |
| ABL90 FLEX PLUS System (K240998) | Radiometer Medicals Aps | 2024-12-13 |
| Atellica® CH Creatinine_3 (Crea3) (K242685) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 |
| XPER Technology PREMIUM Pro Blood Glucose Monitoring System (K221349) | Taidoc Technology Corporation | 2024-11-19 |
| Nova Allegro UACR Assay, Nova Allegro Analyzer (K221813) | Nova Biomedical Corporation | 2024-11-19 |
| RIGHTEST Blood Glucose Monitoring System Max Tel (K240637) | Bionime Corporation | 2024-11-04 |