BEUDAMED
    3,100 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid L24 Cochlear Implant System

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY+

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·THERMATRX OFFICE THERMO THERAPY

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

    FDA Pre-Market Approval
    FDA Class 3 ·NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL CATHETERS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Manual Retraction Kit

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CIBA VISION EXTENDED WEAR SOFT CONTACT LENSES

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Aveir™ VR Delivery Catheter, Aveir™ DR Delivery Catheter

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV ASSAY

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TRIFECTA HEART VALVE

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Prestiege LP Cervical Disc - Two-Level

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

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM