BEUDAMED
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    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·HERCEPTEST

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

    FDA Pre-Market Approval
    FDA Class 3 ·Arctic Front Advance Pro Cardiac Cryoablation Catheter

    Lens, Contact (Other Material) - Daily

    FDA Pre-Market Approval
    FDA Class 2 ·MENICON SF-P (TM)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC SPRINT FAMILY OF TRANSVENOUS DEFIBRILLATION LEADS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt MR

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity m HR HPV Assay

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX MRI LEAD

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Spatz3 Adjustable Balloon System

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION VISTA TPSA ASSAY

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNX CADENCE VASCULAR CLOSURE DEVICE

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 System

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·COLLACOTE, COLLA TAPE, COLLA PLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTOME CUTTING BALLOON DILATATION DEVICE

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·GENESIS & EON FAMILY OF NEUORSTIMULATION DEVICES

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

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ICD MODEL INSYNC 7272 SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·Ceramic TRANSCEND® Hip Articulation System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

    FDA Pre-Market Approval
    Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™