BEUDAMED
    947 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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

    Diagnostic Low Electric Field

    FDA Pre-Market Approval
    FDA Class 3 ·MarginProbe System

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·Visian Toric ICL (Implantable Collamer Lens)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Toric1-Piece Intraocular Lenses (IOLs) Models ZCT300 and ZCT400

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·ReShape Integrated Dual Ballon System

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·LVIS and LVIS Jr.

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Onclarity HPV Assay

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·COFLEX INTERLAMINAR TECHNOLOGY

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT (DERMAL FILLERS)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI and Endurity MRI family of Pacemakers

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

    Tricuspid Valve Repair Device, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·TriClip G4 System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·Tryton Side Branch Stent

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·PulseSelect™ Pulsed Field Ablation (PFA) system

    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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs