BEUDAMED
    10,000 results · 50ms · Sources: EU EUDAMED, US FDA

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRESTIGE® Cervical Disc

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    FDA Pre-Market Approval
    FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

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

    FDA Pre-Market Approval
    FDA Class 3 ·MetriQ Pump

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    FDA Pre-Market Approval
    FDA Class 3 ·TRUFILL n-BCA Liquid Embolic System

    Filler, Bone Void, Synthetic Peptide

    FDA Pre-Market Approval
    FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH1

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

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·SCULPTRA AESTHETIC

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA VENTRICULAR SUPPORT SYSTEMS

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·ESTEEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN 4-SITE HEADER ICD MODELS