BEUDAMED
    913 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: FDA Class 2 × Regulation: Us FDA × Clear all

    Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORGENTEC ANTI-SS-A(RO) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    NEGATIVE CONTROL SERUM FOR CF RO ID

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AUTOSTAT II ANTI-SS-A/RO ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANTI-ENA ANTIBODY TEST [SS-A (RO)]

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SS-A(RO) & SS-B(LA) ANTIBODY ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

    FDA classification
    FDA Class 2 ·Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

    Radioimmunoassay For Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

    Radioimmunoassay For Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

    Fluorescence Polarization Immunoassay For Cyclosporine

    FDA Pre-Market Approval
    FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD