BEUDAMED
    10,000 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    FDA Pre-Market Approval
    FDA Class 3 ·EndoForce™ Connector for Endovascular Venous Anastomosis

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    FDA Pre-Market Approval
    FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

    LIFEPAK 12 BIPHASIC

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PELLETHANE 75D

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    STELA MODEL UJ45 PACING LEADS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL M SERIES ETCO2 OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AECD ARRHYTHMIA DETECTION SOFTWARE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    STERILIZATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular