BEUDAMED
    947 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Carotid Sinus Nerve

    FDA Pre-Market Approval
    FDA Class 3 ·Barostim System

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Aesculap Implant Systems

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Enroute Transcarotid Stent System

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Microny family of Pacemakers

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE

    Implant, Dermal, For Aesthetic Use

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

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

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

    FDA Pre-Market Approval
    FDA Class 3 ·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra, Assura, Epic+/HF/HF+/II HF/II+

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TREO Abdominal Stent-Graft System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist

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

    FDA Pre-Market Approval
    FDA Class 3 ·Prolieve Thermodilation System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE Transcarotid Stent System

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EMBLEM S-ICD VI Electrode (Lead)

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERION INTERSPINOUS SPACER

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·Raindrop® Near Vision Inlay

    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