| FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| Amylase2 (K210633) | Abbott Ireland Diagnostics Division | 2022-05-26 |
| Assure Titanium Blood Glucose Monitoring System (K200788) | Arkray, Inc. | 2022-05-23 |
| Alinity i STAT High Sensitivity Troponin-I (K202525) | Abbott Laboratories Diagnostics Division | 2022-05-19 |
| Elecsys Testosterone II (K211685) | Roche Diagnostics | 2022-05-06 |
| IWL2020 Blood Glucose Monitoring System (K203711) | Roche Diabetes Care, Inc. | 2022-05-06 |
| MTM301 Blood Glucose and Ketone Monitoring System (K202534) | Apex BioTechnology Corp. | 2022-04-06 |
| Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream (K213808) | Co-Innovation Biotech Co., Ltd. | 2022-04-05 |
| Elecsys proBNP II, Elecsys proBNP II STAT (K210546) | Roche Diagnostics | 2022-03-31 |
| GAL-1A Plus Blood Glucose Monitoring System (K213887) | Apex BioTechnology Corp. | 2022-03-29 |
| Creatinine2 (K210452) | Abbott Ireland Diagnostics Division | 2022-03-22 |
| Albumin BCP2 (K203530) | Abbott Ireland Diagnostics Division | 2022-03-18 |
| One Step Pregnancy Test (K210341) | Spd Swiss Precision Diagnostics GmbH | 2022-03-10 |
| GLP systems Track (K213486) | Abbott Laboratories | 2022-03-10 |
| CardioChek Plus Test System; CardioChek Plus Home Test System (K193406) | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2022-02-26 |
| SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream (K212447) | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022-02-18 |
| t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (K203234) | Tandem Diabetes Care, Inc. | 2022-02-15 |
| BD Vacutainer UltraTouch Push Button Blood Collection Set (K212724) | Becton, Dickinson and Company | 2022-02-04 |
| Alltest Pregnancy Rapid Combo Test Cassette (K203272) | Hangzhou AllTest Biotech Co., Ltd. | 2022-01-31 |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648) | Ortho Clinical Diagnostics | 2022-01-28 |
| SmartAdjust technology (K203774) | Insulet Corporation | 2022-01-27 |
| Omnipod 5 ACE Pump (Pod) (K203768) | Insulet Corporation | 2022-01-27 |
| Omnipod 5 SmartBolus Calculator (K203772) | Insulet Corporation | 2022-01-27 |
| POMC/PCSK1/LEPR CDx Panel (DEN200059) | Preventiongenetics, LLC | 2022-01-21 |
| Contour® next GEN Blood Glucose Monitoring System (K193407) | Ascensia Diabetes Care | 2021-12-23 |
| Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221) | Diazyme Laboratories, Inc. | 2021-12-13 |
| Atellica CH Enzymatic Creatinine_3 (ECre3) (K212223) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 |
| Albumin BCG2 (K203248) | Abbott Ireland Diagnostics Division | 2021-11-23 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K210943) | Abbott Diabetes Care, Inc. | 2021-11-22 |
| ST AIA-PACK BNP Assay (K211199) | Tosoh Bioscience, Inc. | 2021-11-08 |
| Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single (K212019) | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-11-04 |
| Piccolo Potassium Test System (K200865) | Abaxis, Inc. | 2021-10-20 |
| MultiSure GK Link Blood Glucose and Ketone Monitoring System (K201880) | Apex BioTechnology Corp. | 2021-10-15 |
| CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System (K201394) | I-Sens, Inc. | 2021-10-05 |
| VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (K201312) | Ortho Clinical Diagnostics | 2021-10-04 |
| Advisor Pro Platform (K210561) | DreaMed Diabetes, Ltd. | 2021-09-28 |
| Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (K200898) | Medicon Hellas S.A | 2021-09-21 |
| Elecsys Troponin T Gen 5 (K201441) | Roche Diagnostics | 2021-09-21 |
| GlucoSure HT Plus Blood Glucose Monitoring System (K202885) | Apex BioTechnology Corp. | 2021-09-15 |
| EASYMAX Tag Self-Monitoring Blood Glucose System (K201258) | Eps Bio Technology Corp. | 2021-09-01 |
| Elecsys Vitamin D total III (K210901) | Roche Diagnostics | 2021-09-01 |
| ADVIA Centaur Enhanced Liver Fibrosis (ELF) (DEN190056) | Siemens Healthcare Diagnostics, Inc. | 2021-08-20 |
| GEM Premier 5000 (K203790) | Instrumentation Laboratory CO | 2021-08-20 |
| Elecsys HCG STAT (K203227) | Roche Diagnostics | 2021-08-18 |
| Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System (K203089) | Dexcom, Inc. | 2021-08-17 |
| Clearblue® Early Digital Pregnancy Test (K200913) | Spd Swiss Precision Diagnostics GmbH | 2021-08-13 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K210958) | Abbott Point of Care, Inc. | 2021-08-13 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K211102) | Abbott Diabetes Care, Inc. | 2021-08-11 |
| CONTOUR® NEXT ONE Blood Glucose Monitoring System (K210687) | Ascensia Diabetes Care | 2021-08-11 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (K200904) | Tosoh Bioscience, Inc. | 2021-08-05 |
| Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) (K203246) | Atlas Link Technology Co., Ltd. | 2021-08-04 |
| OPTI® B-Lac Cassette (K200986) | Opti Medical Systems, Inc. | 2021-08-02 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) (K201761) | Abbott Diabetes Care, Inc. | 2021-07-30 |
| CHIRAVAC Blood Collection Needles (K201009) | Chirana T. Injecta | 2021-07-21 |
| Dexcom G6 Continuous Glucose Monitoring (CGM) System (K201328) | Dexcom, Inc. | 2021-07-15 |
| Finetest Lite Blood Glucose Monitoring System (K203562) | Osang Healthcare Co. , Ltd. | 2021-07-13 |
| ADVIA Centaur® Total hCG assay (K200210) | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 |
| ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (K200256) | Siemens Healthcare Diagnostics, Inc. | 2021-07-02 |
| Yumizen C1200 Creatinine PAP (K193649) | HORIBA ABX SAS | 2021-05-10 |
| Bigfoot Unity Diabetes Management System (K202145) | Bigfoot Biomedical, Inc. | 2021-05-07 |
| IDS Cortisol (K202136) | Immunodiagnostic Systems , Ltd. | 2021-04-13 |
| EasyPoint Blood Collection Plus (K202325) | Retractable Technologies, Inc. | 2021-04-09 |
| Safety Blood Collection Sets for Single Use (K202188) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-02-19 |
| IMMULITE® 2000 Cortisol (K202826) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| IMMULITE/IMMULITE® 1000 Cortisol (K203270) | Siemens Healthcare Diagnostics Products, Ltd. | 2021-01-15 |
| Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (K200876) | Dexcom, Inc. | 2020-12-04 |
| Finetest Lite Smart Blood Glucose Monitoring System (K201396) | Osang Healthcare Co. , Ltd. | 2020-10-16 |
| LIAISON Testosterone xt (K201908) | DiaSorin, Inc. | 2020-10-15 |
| SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (K200544) | Diamond Diagnostics, Inc. | 2020-10-01 |
| IDS-iSYS Ostase BAP (K200475) | Immunodiagnostic Systems , Ltd. | 2020-09-30 |
| BD Preset Syringe & BD A-Line Syringe (K202446) | Becton, Dickinson and Company | 2020-09-25 |
| GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System (K193340) | Microtech Medical, Inc. | 2020-09-11 |
| KetoSens BT Blood B-Ketone Monitoring System (K201551) | I-Sens, Inc. | 2020-09-09 |
| CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV (K192730) | Biosystems S.A. | 2020-09-09 |
| Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (K200027) | Jiangsu Caina Medical Co.,Ltd | 2020-09-09 |
| DreaMed Advisor Pro (K201476) | DreaMed Diabetes, Ltd. | 2020-08-28 |
| ST AIA-PACK BNP (K192380) | Fujirebio Diagnostics,Inc. | 2020-08-24 |
| Distinct® Early Detection Pregnancy Test (K193318) | ACON Laboratories, Inc. | 2020-08-20 |
| AncestryDNA Saliva Collection Kit (K192947) | Ancestry Genomics, Inc. | 2020-08-13 |
| hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream (K200133) | Safecare Biotech (Hangzhou) Co., Ltd. | 2020-08-13 |
| Pointe Scientific Creatinine Kinase (CK) Reagent Set (K191296) | Medtest DX | 2020-08-11 |
| Cell-Free DNA BCT (DEN200001) | Streck, Inc. | 2020-08-07 |
| Quantisal Oral Fluid Collection Device (K200801) | Immunalysis Corporation | 2020-07-28 |
| Control-IQ Technology (K200467) | Tandem Diabetes Care, Inc. | 2020-06-16 |
| FreeStyle Libre 2 Flash Glucose Monitoring System (K193371) | Abbott Diabetes Care, Inc. | 2020-06-12 |
| epoc Blood Analysis System (K200107) | Epocal, Inc. | 2020-06-05 |
| VivaChek Blood Glucose and B-Ketone Monitoring System (K192957) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2020-06-05 |
| Livongo Blood Glucose Monitoring System (BG1000) (K200277) | Livongo Health, Inc. | 2020-06-04 |
| t:slim X2 Insulin Pump with Interoperable Technology (K201214) | Tandem Diabetes Care, Inc. | 2020-06-04 |
| ADVIA Centaur Vitamin D Total (VitD) (K200509) | Siemens Healthcare Diagnostics, Inc. | 2020-05-29 |
| LIAISON® Folate (K192586) | DiaSorin, Inc. | 2020-05-06 |
| Bevel Up Holder (K193074) | Nsp Tech Pte, Ltd. | 2020-04-21 |
| MyCare Psychiatry Clozapine Assay Kit (DEN190028) | Saladax Biomedical, Inc. | 2020-04-16 |
| Stat Profile Prime Plus Analyzer System (K200403) | Nova Biomedical Corporation | 2020-04-14 |
| i-STAT CG4+ Cartridge with the i-STAT 1 System (K200492) | Abbott Point of Care, Inc. | 2020-04-09 |
| RAPIDPoint 500e Blood Gas System (K192240) | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 |
| Tina-quant Hemoglobin A1cDx Gen.3 (K193053) | Roche Diagnostics Operations (Rdo) | 2020-03-26 |
| Bioland Blood Glucose Monitoring System (K191657) | Bioland Technology, Ltd. | 2020-03-20 |
| Stat Profile Prime Plus Analyzer System (K200349) | Nova Biomedical Corporation | 2020-03-13 |
| Steripath Gen2 Blood Collection System (K192247) | Magnolia Medical Technologies, Inc. | 2020-02-28 |