BEUDAMED
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    Implantable Cardioverter Defibrillator (Non-Crt)

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

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·SMART AND SMART CONTROL NITINOL STENT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·SPECTRANETICS LASER SHEATHS (SLS)

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT, PREMIXED

    Intervertebral Fusion Device With Bone Graft, Lumbar

    FDA Pre-Market Approval
    FDA Class 2 ·AFFINITY ANTERIOR CERVICAL CAGE SYSTEM

    Aspiration Therapy System

    FDA Pre-Market Approval
    FDA Class 3 ·AspireAssist

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

    Pulmonary Valve Prosthesis Percutaneously Delivered

    FDA Pre-Market Approval
    9600CR Crimper

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COLOGUARD

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Revo MRI SureScan IPG

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·COFLEX® INTERLAMINAR TECHNOLOGY

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·XACT® Carotid Stent System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis