BEUDAMED
    10,000 results · 53ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Endurant, Endurant II, and Endurant IIs Stent Graft System

    Stimulator, Electrical, Implantable, For Incontinence

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Solo Smart Heart Valve

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Sense Lead

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Verds, Sensia IPG ; Advisa DR IPG; Advisa DR & SR MRI IPG; Relia IPG

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G Pump

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve Evolut R Transcatheter Aortic Valve System, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valv

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Spinal Cord Stimulati

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Sense Lead, Vitatron Crystalline Lead

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Preveleak Surgical Sealant

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Sense Lead, Vitatron Crystalline Lead

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RHA® Redensity™, RHA®2, RHA®3, RHA®4

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·EGFR pharmDx

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Pulse Generators

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant