BEUDAMED
    10,000 results · 111ms · Sources: EU EUDAMED, US FDA

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    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)

    Implantable Cardioverter Defibrillator (Non-Crt)

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

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·remede® System

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

    Stimulator, Electrical, Implantable, For Incontinence

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

    Pulmonary Valve Prosthesis Percutaneously Delivered

    FDA Pre-Market Approval
    Edwards Crimper 9600CR

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TRIFECTA VALVE

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC FAMILY & CONCERTO CRT-ICDS

    Optical Diagnostic Device For Melanoma Detection

    FDA Pre-Market Approval
    FDA Class 3 ·MELAFIND

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate II Left Ventricular Assist System

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

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

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