BEUDAMED
    488 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3100A FREQUENCY OSCILLATORY VENTILATOR

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LifePulse High Frequency Ventilator

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·ReSure Sealant

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LifePulse High Frequency Ventilator

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LifePulse High Frequency Ventilator

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

    FDA Pre-Market Approval
    FDA Class 3 ·ResQCPR™ System

    Ventilator, High Frequency

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

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·ReSure Sealant

    Ventilator, High Frequency

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

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·4Kscore Test

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE/IMMULITE 1000 THIRD GENERATION PSA

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·BAYER IMMUNO 1 COMPLEXED PSA ASSAY

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

    FDA Pre-Market Approval
    FDA Class 3 ·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Complexed PSA (cPSA) Assay

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE 2000 Prostate-Specific Antigen (PSA)

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·BAYER ADVIA IMS COMPLEXED PSA ASSAY

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Complexed PSA (cPSA) Assay