BEUDAMED
    9,270 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: FDA Class 3 ×

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·SOLESTA

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·PROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SPRINT QUATTRO SECURE LEAD

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·ThinPrep Processors and ThinPrep Imaging System

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·HIGH FREQUENCY OSCILLATING VENTILATOR

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF ICDS

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·ANTHEM, ALLURE, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF ICDS

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT DEVICE

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Solesta Injectable Gel

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

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

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE