BEUDAMED
    10,000 results · 50ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink Encore Programmer, CareLink Encore Programmer Head, CareLink SmartSync Device Manager Patient Connector, CareLi

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Algovita Spinal Cord Stimulation System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Biocor, Biocor Supra, Epic, Epic Supra

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·HV Splitter/Adaptor kit, Sprint Quattro Lead