BEUDAMED
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    Filters Classification: FDA Class 3 ×

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

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

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Microny II SR+

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable System for Remodulin

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer Muscular VSD Occluder

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE REFYNE and RESTYLANE DEFYNE

    Stent, Superficial Femoral Artery, Drug-Eluting

    FDA Pre-Market Approval
    FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·Integrity Coronary Stent Systems

    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

    FDA Pre-Market Approval
    FDA Class 3 ·Vysis CLL FISH Probe Kit

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Novus Lead

    Stimulator, Invasive Bone Growth

    FDA Pre-Market Approval
    FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor Saline-Filled and SPECTRUM® Breast Implants

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·NG3 Implantable Cardioverter Defibrillator (ICD), ORIGEN, INOGEN, DYNAGEN EL ICD'S; NG2 Implantable Cardioverter Defibri

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Spinal Cord Stimulation (SCS)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Stability Quad MRI Surescan

    Pulse Generator, Permanent, Implantable

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