BEUDAMED
    10,000 results · 43ms · Sources: EU EUDAMED, US FDA

    DIMENSION EXL WITH LM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GentleCath Glide Intermittent Urinary Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

    FDA 510(k)
    FDA Class 2 ·Hematology

    Atellica® IM High-Sensitivity Troponin I (TnIH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

    FDA 510(k)
    FDA Class 2 ·Immunology

    Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GentleCath Glide Intermittent Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry