13 results
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65ms
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Sources: EU EUDAMED, US FDA
SYRINGE SINGLE 200CC INJECTOR SY
FDA Adverse Event
Malfunction
·BRACCO INJENEERING S.A.·Product code DXT·December 6, 2024
SYRINGE SINGLE 200CC INJECTOR SY
FDA Adverse Event
Malfunction
·BRACCO INJENEERING S.A.·Product code DXT·December 6, 2024
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code MMI·September 17, 2025
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·November 8, 2022
ACIST Europe BV
Authorized representative
🇳🇱 Netherlands·4 Manufacturers·14 Devices
ACIST Europe BV
Importer
🇳🇱 Netherlands·4 Manufacturers
Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood.
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGA·February 21, 2008
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Welch Allyn Limited
Importer
🇮🇪 Ireland·8 Manufacturers
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Mediq Suomi Oy
Importer
🇫🇮 Finland·61 Manufacturers
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices