BEUDAMED
    398 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·CONCEPTUS ESSURE SYSTEM

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain StarFix Lead

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SelectSecure Lead

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Sprint Quattro Lead Models 6935, 6944, 6947

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Onyx Liquid Embolic System

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT™ Absorbable Hemostat, SURGICEL® SNOW™ Absorbable Hemostat

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM IMPLANTABLE NEUROSTIMULATORS

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Sapien 3 - Transcatheter Heart Valve and Accessories

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    FDA Pre-Market Approval
    FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·IMPLANTABLE NEUROSTIMULATORS FOR SPINAL CORD STIMULATION

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

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

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·ACTIVA THERAPY FOR DBS

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor Saline-Filled and SPECTRUM® Breast Implants

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    FDA Pre-Market Approval
    FDA Class 3 ·MiSight 1 day (omafilcon A)

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor MemoryGel® Silicone Gel-Filled Breast Implants