BEUDAMED
    60 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    PATLOG 2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    HemosIL Liquid Anti-Xa

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05)

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemosIL Liquid Anti-Xa

    FDA 510(k)
    FDA Class 2 ·Hematology

    Bone Sonometer

    FDA Pre-Market Approval
    FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

    DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

    DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

    FDA 510(k)
    FDA Class 2 ·Immunology

    AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

    FDA 510(k)
    FDA Class 2 ·Immunology

    AXIS-SHIELD ACVTIVE-B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry