BEUDAMED
    10,000 results · 51ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·CERVICAL-STIM

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX INJECTABLE GEL

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMX PSAS

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony™ OptiBlue™ Extended Range of Vision (ERV) IOL

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·INCRAFT AAA Stent Graft System

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

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

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

    FDA Pre-Market Approval
    FDA Class 3 ·TactiFlex Ablation Catheter, Sensor Enabled

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·MARA Water Vapor Ablation System

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·MFK IOL

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·polymacon Soft (Hydrophilic) Extended Wear Contact Lenses

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FR3 Defibrillator

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE FAMILY OF ICDS