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Nova Biomedical Corporation

35 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blo recall (Z-0681-2025)Nova Biomedical Corporation2024-12-20
StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription recall (Z-0682-2025)Nova Biomedical Corporation2024-12-20
StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Pres recall (Z-0683-2025)Nova Biomedical Corporation2024-12-20
Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, pl recall (Z-0207-2024)Nova Biomedical Corporation2023-11-01
Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, recall (Z-0208-2024)Nova Biomedical Corporation2023-11-01
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Me recall (Z-0650-2014)Nova Biomedical Corporation2014-01-09
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The No recall (Z-1897-2013)Nova Biomedical Corporation2013-08-09
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova recall (Z-1898-2013)Nova Biomedical Corporation2013-08-09
Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nov recall (Z-1899-2013)Nova Biomedical Corporation2013-08-09
Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: recall (Z-1900-2013)Nova Biomedical Corporation2013-08-09
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitte recall (Z-1901-2013)Nova Biomedical Corporation2013-08-09
Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: recall (Z-1902-2013)Nova Biomedical Corporation2013-08-09
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: T recall (Z-1903-2013)Nova Biomedical Corporation2013-08-09
Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max G recall (Z-1904-2013)Nova Biomedical Corporation2013-08-09
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product u recall (Z-1905-2013)Nova Biomedical Corporation2013-08-09
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Pr recall (Z-1906-2013)Nova Biomedical Corporation2013-08-09
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 recall (Z-1153-2013)Nova Biomedical Corporation2013-04-19
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only) recall (Z-1154-2013)Nova Biomedical Corporation2013-04-19
Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Wa recall (Z-1783-2010)Nova Biomedical Corporation2010-06-10
Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX anal recall (Z-1328-2009)Nova Biomedical Corporation2009-05-07
Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedic recall (Z-1472-2008)Nova Biomedical Corporation2008-09-23
Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Walth recall (Z-0724-2008)Nova Biomedical Corporation2008-02-16
Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 recall (Z-0725-2008)Nova Biomedical Corporation2008-02-16
Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 recall (Z-0726-2008)Nova Biomedical Corporation2008-02-16
Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA recall (Z-0295-2008)Nova Biomedical Corporation2008-01-17
Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942 recall (Z-0576-06)Nova Biomedical Corporation2006-02-28
Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413 recall (Z-0577-06)Nova Biomedical Corporation2006-02-28
CCX Operating Software , Version 4.08 recall (Z-0578-06)Nova Biomedical Corporation2006-02-28
Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942 recall (Z-0826-04)Nova Biomedical Corporation2004-07-20
Stat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413 recall (Z-0827-04)Nova Biomedical Corporation2004-07-20
Stat Profile Critical Care Xpress CCX (R) Analyzer Catalog Number: 37562 R= Refurbished recall (Z-0828-04)Nova Biomedical Corporation2004-07-20
Stat Profile Critical Care Xpress CCX+ (R) Anaylzer Catalog NUmber: 37555 R= Refurbished recall (Z-0829-04)Nova Biomedical Corporation2004-07-20
ABG Replacement Pump Assembly Catalog Number: 37092 recall (Z-0830-04)Nova Biomedical Corporation2004-07-20
Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra recall (Z-0060-04)Nova Biomedical Corporation2003-10-24
Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with recall (Z-0061-04)Nova Biomedical Corporation2003-10-24

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Every clearance here is in the API, with alerts when new ones post.