BEUDAMED
    2,118 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·INSPIRIS RESILIA Aortic Valve

    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

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·remede System

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

    FDA Pre-Market Approval
    FDA Class 3 ·CERAMAX Ceramic Hip System

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

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

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

    Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

    FDA Pre-Market Approval
    FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·PERFLUORON

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EON NEUROSTIMULATION SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·mySCS™ GO Therapy Controller App

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·AUDALLION BEAMFORMER

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VITESSE POINT 9 MM X80 & EXTREME POINT 9MM X80 PERCUTANEOUS CORONARY ANGIOPLASTY CATHETER, MODELS 110-004 AND 110-002