BEUDAMED
    10,000 results · 51ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) ; FLEXABILITY ABLATION CATHETER(UNI-DIRECTIONAL)

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE® Injectable Gels

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Biomet EBI Bone Healing System

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE +/PS+

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE VDD 2 LEAD, SERVICE KIT-PACEMAKER REPAIR KIT, VITATRON BRILLIANT S+ VDD LEAD

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD L1 IHC 22C3 pharmDx

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

    Stent, Superficial Femoral Artery, Drug-Eluting

    FDA Pre-Market Approval
    FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·VIABAHN ENDOPROSTHESIS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE TAG Thoracic Endoprosthesis

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device and Delivery System

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus