BEUDAMED
    275 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HPV Test

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·SECURE -C CERVICAL ARTIFICIAL DISC

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·SleepSync Programmer

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·VITATRON DA+ C SERIES PULSE GENERATORS

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

    FDA Pre-Market Approval
    FDA Class 3 ·LCS (R) Total Knee System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·Therakos CELLEX Procedural Kit

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·SIR-SPHERES

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy Systems

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) System

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPARED FUSION DEVICE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM