BEUDAMED
    222 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN ETI-MAK-2 PLUS

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·Lacrosse NSE ALPHA Coronary Dilatation Catheter

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN HBSAG CONFIRMATORY TEST

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER NAV AND EZ STEER NAV DS CATHETERS

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS PRESCRIPTION INSERTS

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS PRESCRIPTION INSERTS

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS® Corneal Implants

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·NIT-OCCLUD SYSTEM

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS PRESCRIPTION INSERTS

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS CORNEAL RING SEGMENTS

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HEALTHTRONICS OSSATRON