| BD Vacutainer® One Use Holder (K242320) | Becton, Dickinson and Company | 2024-11-01 |
| BD Vacutainer® Citrate Blood Collection Tubes (K240455) | Becton, Dickinson and Company | 2024-10-31 |
| IDS-iSYS Free Testosterone (K240865) | Immunodiagnostic Systems Limited | 2024-10-23 |
| Alkaline Phosphatase (K240468) | Abbott Laboratories Diagnostics Division | 2024-10-16 |
| HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (K240242) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 |
| Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (K240640) | Sejoy Biomedical Co., Ltd. | 2024-10-08 |
| YSI 2900C Biochemistry Analyzer (K210933) | Ysi, Inc. | 2024-09-30 |
| Eversense 365 Continuous Glucose Monitoring (CGM) System (K241335) | Senseonics, Incorporated | 2024-09-16 |
| Hipro Glycosylated Hemoglobin (HbA1c) Test System (K220999) | Shijiazhuang Hipro Biotechnology Co., Ltd. | 2024-09-12 |
| embecta Insulin Delivery System (K234027) | Embecta Medical I, LLC | 2024-08-30 |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (K241787) | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 |
| SmartAdjust™ Technology (K241777) | Insulet Corporation | 2024-08-26 |
| VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (K222126) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 |
| Shinetell Digital Pregnancy Test (K241978) | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 |
| CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (K232404) | Medicon Hellas S.A | 2024-08-09 |
| Innovita HCG Pregnancy Rapid Combo Test (K241919) | Innovita (Tangshan) Biological Technology Co., Ltd. | 2024-08-02 |
| ARCHITECT Active-B12 (Holotranscobalamin) (K233541) | Axis-Shield Diagnostics, Ltd. | 2024-07-31 |
| EasyStat 300 (K220328) | Medica Corporation | 2024-07-26 |
| Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (K241800) | Siemens Healthcare Diagnostics, Inc. | 2024-07-26 |
| Cell-Free DNA BCT (K231776) | Streck, Inc. | 2024-07-26 |
| Tandem Mobi Insulin Pump with interoperable technology (K241078) | Tandem Diabetes Care, Inc. | 2024-07-26 |
| Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165) | Siemens Healthcare Diagnostics, Inc. | 2024-07-25 |
| Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (K234091) | Genalyte, Inc. | 2024-07-22 |
| VACUETTE® QUICKSHIELD Complete (Plus) (K233979) | Greiner Bio-One North America, Inc. | 2024-07-19 |
| MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream (K240643) | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 |
| Elecsys Folate III (K233060) | Roche Diagnostics | 2024-06-17 |
| Libre Rio Continuous Glucose Monitoring System (K233861) | Abbott Diabetes Care | 2024-06-07 |
| WaveSense Jazz Blood Glucose Monitoring System (K241304) | Agamatrix | 2024-06-06 |
| Distinct® Digital Pregnancy Test (K232715) | ACON Laboratories, Inc. | 2024-05-31 |
| Lingo Glucose System (K233655) | Abbott | 2024-05-29 |
| SmartAdjust(TM) technology (K232741) | Insulet Corporation | 2024-05-29 |
| DEKA ACE Pump System (K241178) | Deka Research and Development | 2024-05-24 |
| CamAPS FX (K232603) | Camdiab , Ltd. | 2024-05-23 |
| VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581) | Ortho Clinical Diagnostics | 2024-05-08 |
| Emily's Care Nourish Test System (Model 1) (K234088) | Lactation Lab, Inc. | 2024-05-03 |
| Access Intrinsic Factor Ab (K240800) | Beckman Coulter, Inc. | 2024-05-03 |
| Eversense AP CGM System (DEN230052) | Senseonics, Incorporated | 2024-04-29 |
| cobas pulse blood glucose monitoring system (K220272) | Roche Diagnostics | 2024-04-26 |
| Dexcom G7 Continuous Glucose Monitoring System (K240902) | Dexcom, Inc. | 2024-04-23 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System (K233537) | Abbott Diabetes Care, Inc. | 2024-04-23 |
| Access Ostase (K232904) | Beckman Coulter | 2024-04-15 |
| HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx (K233624) | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 |
| Access NT-proBNP (K232164) | Beckman Coulter, Inc. | 2024-04-12 |
| MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (K232587) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024-04-12 |
| ACESO Early Pregnancy Test (K234152) | Aceso Laboratories, Inc. | 2024-04-05 |
| ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (K233050) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 |
| Elecsys PTH , Elecsys PTH STAT (K231927) | Roche Diagnostics | 2024-03-22 |
| Tandem Mobi insulin pump with interoperable technology (K240309) | Tandem Diabetes Care, Inc. | 2024-03-21 |
| PATHFAST®hs-cTnI-II (K231974) | Phc Corporation | 2024-03-20 |
| DEKA ACE Pump System (K233952) | Deka Research and Development | 2024-03-13 |
| DEKA Loop (K234055) | Deka Research and Development | 2024-03-13 |
| Safety Sliding Blood Collection Set (K232781) | Jiangsu Caina Medical Co.,Ltd | 2024-03-07 |
| Access Free T4 (K240273) | Beckman Coulter, Inc. | 2024-03-06 |
| Stelo Glucose Biosensor System (K234070) | Dexcom, Inc. | 2024-03-05 |
| Access Intact PTH (K232791) | Beckman Coulter, Inc. | 2024-03-01 |
| Dexcom G7 Continuous Glucose Monitoring System (K234133) | Dexcom, Inc. | 2024-02-26 |
| StatStrip Glucose Hospital Meter System (K232075) | Nova Biomedical Corporation | 2024-02-23 |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System (K231679) | Ascensia Diabetes Care | 2024-02-23 |
| Access CK-MB (K234005) | Beckman Coulter, Inc. | 2024-02-16 |
| Access SHBG (K233480) | Beckman Coulter, Inc. | 2024-02-08 |
| FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream (K233174) | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 |
| BD Vacutainer® K2 EDTA Blood Collection Tubes (K231373) | Becton, Dickinson and Company | 2024-02-02 |
| Clearblue® Early Detection Pregnancy Test (K240025) | Spd Swiss Precision Diagnostics GmbH | 2024-01-31 |
| EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II (K232864) | Nantong Egens Biotechnology Co., Ltd. | 2024-01-26 |
| LifeOutcomes C-Quest™ Blood Culture Sampling Device (K231282) | Lifeoutcomes, LLC | 2024-01-26 |
| BD Vacutainer® Fluoride Blood Collection Tubes (K231237) | Becton, Dickinson and Company | 2024-01-19 |
| RIGHTEST Blood Glucose Monitoring System Max Tel (K231192) | Bionime Corporation | 2024-01-19 |
| VivaChek Link Plus Blood Glucose Monitoring System (K233058) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
| Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder (K232881) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023-12-22 |
| Inessa System (K230545) | Triple Jump Israel , Ltd. | 2023-12-20 |
| BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (K230855) | Becton, Dickinson and Company | 2023-12-20 |
| Access hsTnI (K222881) | Beckman Coulter, Inc. | 2023-12-18 |
| iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 |
| ProNephro AKI™ (NGAL) (K232761) | Bioporto Diagnostic, Inc. | 2023-12-07 |
| Monarch Blood Collection Set (K232308) | The Monarch Company | 2023-12-04 |
| Access hsTnI (K230648) | Beckman Coulter, Inc. | 2023-12-04 |
| BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (K230391) | Becton, Dickinson and Company | 2023-12-01 |
| TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System (K231476) | Sinocare, Inc. | 2023-12-01 |
| BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube (K230493) | Becton, Dickinson and Company | 2023-11-27 |
| Quantisal™ Oral Fluid Collection Device (K232898) | Immunalysis Corporation | 2023-11-21 |
| t:slim X2 Insulin Pump with Interoperable Technology (K232380) | Tandem Diabetes Care, Inc. | 2023-11-03 |
| Control-IQ Technology (K232382) | Tandem Diabetes Care, Inc. | 2023-11-03 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230285) | Abbott Point of Care, Inc. | 2023-10-27 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230275) | Abbott Point of Care, Inc. | 2023-10-27 |
| Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen (K213146) | Jiangsu Rongye Technology Co., Ltd. | 2023-10-27 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230300) | Abbott Point of Care, Inc. | 2023-10-27 |
| SmartBolus Calculator (K231824) | Insulet Corporation | 2023-10-18 |
| Omnipod 5 ACE Pump (K231826) | Insulet Corporation | 2023-10-18 |
| Macro & Micro-Test HCG Pregnancy Test Midstream (K230741) | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2023-10-13 |
| Tandem Mobi insulin pump with interoperable technology (K233044) | Tandem Diabetes Care, Inc. | 2023-10-05 |
| endo.digital Platform (K232722) | DreaMed Diabetes, Ltd. | 2023-10-03 |
| Miris Human Milk Analyzer (HMA) (K223085) | Miris AB | 2023-09-29 |
| UltraFlo-R Push Button Blood Collection Set (K220458) | Innovative Medical Technologies, Inc. | 2023-09-29 |
| Stat Profile Prime Plus Analyzer System (K221900) | Nova Biomedical Corporation | 2023-09-29 |
| PIVO™ Pro Needle-free Blood Collection Device (K230865) | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-28 |
| EasyStat 300 (K220396) | Medica Corporation | 2023-09-26 |
| ADVIA Centaur® NT-proBNPII (PBNPII) (K220265) | Siemens Healthcare Diagnostics, Inc. | 2023-09-24 |
| ALFIS Vitamin D, ALFIS-3 Analyzer (K221817) | Immunostics Inc., | 2023-09-22 |
| iLet® Dosing Decision Software (K232224) | Beta Bionics, Inc. | 2023-09-22 |
| Cholestech LDX ™ System (K223179) | Alere San Diego, Inc. | 2023-09-20 |