BEUDAMED
    192 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PK-175/2,3m Patient Cable, PK-83, 2.5m

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT TOTAL PSA (LN 6C06)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT FREE PSA (LN 6C07)

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus® Hybrid™ L24 Cochlear Implant System

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD PrepStain System

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·MONOPREP PAP TEST

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·MONOPREP PAP TEST

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus® Hybrid™ L24 Cochlear Implant System

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·AUTOCYTE PREP SYSTEM

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid Cochlear Implant System

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid L24 Implant System

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·PREPSTAIN SYSTEM

    Agent, Occluding, Vascular, Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·VenaSeal™ Closure System

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THIN PREP PROCESSORS