BEUDAMED
    10,000 results · 46ms · Sources: EU EUDAMED, US FDA

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·Paradigm Spine Coflex Interlaminar Stabilization Device

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACMI FALOPE RING BAND

    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

    FDA Pre-Market Approval
    FDA Class 3 ·LCS UNICOMPARTMENTAL KNEE SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    Implant, Intragastric For Morbid Obesity

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Xience Skypoint Everolimus Eluting Coronary Stent System

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx® DownStream® Cartridge (DSC-2)

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SYNERGYST PULSE II GENERATOR

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL TIME ? MMT-522/722 INSULIN PUMP

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·R3 delta Ceramic Acetabular System

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3 Left Ventricular Assist System