BEUDAMED
    2,007 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ALERT SYSTEM-COMPANION II

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY SPIRAL, EASYTRAK 2, EASYTRAK 3

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RELIANCE IS-1/DF-1 LEAD FAMILY,RELIANCE 4-SITE LEAD FAMILY

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTEND

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·CVX-300 CORONARY LASER CATHETER

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·ESTEEM

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·SPECTRANETICS LASER SHEATH (SLS)

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY STEERABLE

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LifePulse High Frequency Ventilator

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·Ceramax® Ceramic Total Hip System

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM

    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    FDA Pre-Market Approval
    FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Oxford Partial Knee System

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL EXACT SPINE SEALANT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·IntellaNav™ XP and IntellaNav MiFi™ XP Ablation Catheters

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

    FDA Pre-Market Approval
    FDA Class 3 ·INTELLANAV MIFI™ Open-Irrigated Ablation Catheters

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·PHEMFILCON A