BEUDAMED
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    Filters Classification: FDA Class 3 ×

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI, Endurity MRI

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON - TB GOLD IN-TUBE

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·ADX PULSE GENERATOR FIRMWARE ANOMALY CORRECTION

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE NITINOL STENT SYSTEM & PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASOSEAL (TM)

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

    Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

    FDA Pre-Market Approval
    FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

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

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNADIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CALIBRATO

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Cordis® EXOSEAL® Vascular Closure Device

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Prometra Programmable Infusion Pump System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·REPLY & ESPRIT SR & DR Pacemakers

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire Upper Airway Stimulation System

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS® Total Knee System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge, SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SU