BEUDAMED
    373 results · 27ms · 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 ·Guardian Sensor 3

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Guardian Sensor 3

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYTEM

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT (TM) OPTICAL BIOPSY SYSTEM

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Device, Testicular Hypothermia

    FDA Pre-Market Approval
    FDA Class 3 ·REPRO-MED - THD

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE