BEUDAMED
    10,000 results · 45ms · Sources: EU EUDAMED, US FDA

    PreludeSYNC EZ Radial Compression Device

    FDA registration
    Merit Medical Australia Pty Ltd.·1 product·🇦🇺 Australia

    MEDICAL COMPONENTS INC

    FDA registration
    MEDICAL COMPONENTS INC·1 product·🇺🇸 United States

    ClampEase

    FDA registration
    ADVANCED VASCULAR DYNAMICS·1 product·🇺🇸 United States

    UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UniCel DxC SYNCHRON Systems Glucose (GLUH) reagent

    Device
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

    SYNCHRON LX/DxC Blood Urea Nitrogen (BUNm)

    Device
    EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

    CHEMISTRY ANALYZER DxC 700 AU with ISE

    Device
    EU IVDR · Eu Ivd Class A ·Beckman Coulter Inc.·On the market·32 countries

    UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

    FDA 510(k)
    FDA Class 2 ·Immunology

    CHEMISTRY ANALYZER DxC 700 AU for Direct Track Sampling

    Device
    EU IVDR · Eu Ivd Class A ·Beckman Coulter Inc.·On the market·32 countries

    ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry