Nova Biomedical Corporation
Nova Biomedical Corporation holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 24 FDA device recalls on record.
Top product codes for Nova Biomedical Corporation
FDA recalls by Nova Biomedical Corporation
10 most recent of 24- Z-3131-2026 — StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
- Z-3130-2026 — StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
- Z-3128-2026 — StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
- Z-3132-2026 — StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
- Z-3129-2026 — StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
- Z-0681-2025 — StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
- Z-0682-2025 — StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
- Z-0683-2025 — StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
- Z-0208-2024 — Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 63368 Stat Profile Prime Plus POC Analyzer (2) PN 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
- Z-0207-2024 — Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nova Biomedical Corporation
- K251281 — Nova Max Creat eGFR Monitoring System
- K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer
- K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer
- K232075 — StatStrip Glucose Hospital Meter System
- K221900 — Stat Profile Prime Plus Analyzer System
- K203549 — Nova Primary Glucose Analyzer System
- K200403 — Stat Profile Prime Plus Analyzer System
- K200204 — Stat Profile Prime Plus Analyzer System
- K200349 — Stat Profile Prime Plus Analyzer System
- K193246 — Stat Profile Prime Plus Analyzer System
- K191626 — Stat Profile Prime ES Comp Plus Analyzer System
- K191365 — Stat Profile Prime ES Comp Plus Analyzer System
- K182549 — StatStrip Xpress 2 Glucose Hospital Meter System
- K182552 — StatStrip Xpress Glucose Hospital Meter System
- K180340 — Stat Profile Prime Plus Analyzer System
- K180186 — Stat Profile Prime Plus Analyzer System
- K180428 — Stat Profile Prime Plus Analyzer System
- K173797 — Stat Profile Prime Plus Analyzer System
- K181043 — StatStrip Glucose Hospital Meter System
- K170464 — StatStrip Xpress Blood Glucose Monitoring System
- K171059 — Nova StatSensor Creatinine Hospital Meter System
- K160990 — Nova Max Uric Acid Monitoring System
- K163490 — StatStrip Xpress 2 Glucose Hospital Meter System
- K161856 — StatStrip Xpress Glucose Hospital Meter System
- K160156 — StatStrip Xpress Blood Glucose Monitoring System
- K152986 — StatStrip Xpress 2 Glucose Hospital Meter System
- K151982 — Stat Profile Prime ABG Analyzer System
- K141907 — 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
- K150461 — StatStrip Xpress Glucose Hospital Meter System
- K150281 — StatStrip Glucose Hospital Meter
- K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
- K132121 — STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
- K131703 — NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
- K131013 — FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
- K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
- K122435 — NOVA ONE BLOOD GLUCOSE MONITOR
- K112638 — NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
- K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
- K110648 — NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.