| Nova Max Creat eGFR Monitoring System (K251281) | Nova Biomedical Corporation | 2026-01-21 |
| Nova Allegro UACR Assay, Nova Allegro Analyzer (K252206) | Nova Biomedical Corporation | 2026-01-09 |
| Nova Allegro HbA1c Assay, Nova Allegro Analyzer (K221326) | Nova Biomedical Corporation | 2024-11-22 |
| Nova Allegro UACR Assay, Nova Allegro Analyzer (K221813) | Nova Biomedical Corporation | 2024-11-19 |
| StatStrip Glucose Hospital Meter System (K232075) | Nova Biomedical Corporation | 2024-02-23 |
| Stat Profile Prime Plus Analyzer System (K221900) | Nova Biomedical Corporation | 2023-09-29 |
| Nova Primary Glucose Analyzer System (K203549) | Nova Biomedical Corporation | 2022-10-18 |
| Stat Profile Prime Plus Analyzer System (K200403) | Nova Biomedical Corporation | 2020-04-14 |
| Stat Profile Prime Plus Analyzer System (K200204) | Nova Biomedical Corporation | 2020-04-06 |
| Stat Profile Prime Plus Analyzer System (K200349) | Nova Biomedical Corporation | 2020-03-13 |
| Stat Profile Prime Plus Analyzer System (K193246) | Nova Biomedical Corporation | 2020-01-24 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191626) | Nova Biomedical Corporation | 2019-08-16 |
| Stat Profile Prime ES Comp Plus Analyzer System (K191365) | Nova Biomedical Corporation | 2019-07-19 |
| StatStrip Xpress Glucose Hospital Meter System (K182552) | Nova Biomedical Corporation | 2018-12-13 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K182549) | Nova Biomedical Corporation | 2018-12-13 |
| Stat Profile Prime Plus Analyzer System (K180340) | Nova Biomedical Corporation | 2018-09-26 |
| Stat Profile Prime Plus Analyzer System (K180186) | Nova Biomedical Corporation | 2018-08-23 |
| Stat Profile Prime Plus Analyzer System (K180428) | Nova Biomedical Corporation | 2018-08-15 |
| Stat Profile Prime Plus Analyzer System (K173797) | Nova Biomedical Corporation | 2018-07-17 |
| StatStrip Glucose Hospital Meter System (K181043) | Nova Biomedical Corporation | 2018-07-12 |
| StatStrip Xpress Blood Glucose Monitoring System (K170464) | Nova Biomedical Corporation | 2017-11-07 |
| Nova StatSensor Creatinine Hospital Meter System (K171059) | Nova Biomedical Corporation | 2017-05-26 |
| Nova Max Uric Acid Monitoring System (K160990) | Nova Biomedical Corporation | 2017-04-11 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K163490) | Nova Biomedical Corporation | 2017-01-06 |
| StatStrip Xpress Glucose Hospital Meter System (K161856) | Nova Biomedical Corporation | 2016-11-15 |
| StatStrip Xpress Blood Glucose Monitoring System (K160156) | Nova Biomedical Corporation | 2016-06-23 |
| StatStrip Xpress 2 Glucose Hospital Meter System (K152986) | Nova Biomedical Corporation | 2016-01-27 |
| Stat Profile Prime ABG Analyzer System (K151982) | Nova Biomedical Corporation | 2015-09-10 |
| STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A (K141907) | Nova Biomedical Corporation | 2015-05-29 |
| StatStrip Xpress Glucose Hospital Meter System (K150461) | Nova Biomedical Corporation | 2015-05-20 |
| StatStrip Glucose Hospital Meter (K150281) | Nova Biomedical Corporation | 2015-05-06 |
| Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) (K142220) | Nova Biomedical Corporation | 2014-10-17 |
| STATSTRIP GLUCOSE HOSPITAL METER SYSTEM (K132121) | Nova Biomedical Corporation | 2014-09-24 |
| NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM (K131703) | Nova Biomedical Corporation | 2014-03-25 |
| FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM (K131013) | Nova Biomedical Corporation | 2013-10-17 |
| NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (K122688) | Nova Biomedical Corporation | 2013-04-04 |
| NOVA ONE BLOOD GLUCOSE MONITOR (K122435) | Nova Biomedical Corporation | 2012-12-20 |
| NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS (K112638) | Nova Biomedical Corporation | 2012-03-09 |
| NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (K112955) | Nova Biomedical Corporation | 2012-01-05 |
| NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM (K110648) | Nova Biomedical Corporation | 2011-08-29 |