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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Livewire TC Ablation, Livewire TC Cables, Safire Ablation Catheter and Safire Cables

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Refyne, Restylane Defyne, and Restylane Kysse

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTAPRO™ and Rotalink Rotational Atherectomy System

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·Gynecare Interceed™ Absorbable Adhesion Barrier

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFeron TB Gold and QuantiFeron TB Gold Plus

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG and Relia IPG

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    FDA Pre-Market Approval
    FDA Class 3 ·Parvovirus B19 IgM Enzyme Immunoassay

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment

    Ventilator, High Frequency

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

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Perclose ProStyle Suture-Mediated Closure and Repair System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·SenTiva™ Generator, SenTiva Duo™ Generator