BEUDAMED
    10,000 results · 104ms · Sources: EU EUDAMED, US FDA

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    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE EXCULDER AAA ENDOPROSTHESIS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS FREE PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Genus DBS System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Interm Therapy System, Verify Evaluation System (SNS Bowel)

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EMBLEM MRI S-CD/ EMBLEM S-CD Pulse Generator (PG)

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire II Upper Airway Stimulator

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY (COMFILCON) SOFT CONTACT LENS

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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·TactiCath Contact Force Ablation Catheter, Sensor Enabled

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EnVeo R and EnVeo PRO delivery catheter system (DCS)

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Crimper 9600CR

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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

    Pulmonary Valve Prosthesis Percutaneously Delivered

    FDA Pre-Market Approval
    Edwards SAPIEN 3 Transcatheter Heart Valve

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

    FDA Pre-Market Approval
    FDA Class 3 ·Dimension Vista TPSA Flex reagent cartridge (K6452)