BEUDAMED
    315 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-MAK-2 PLUS ASSAY AND HBsAg CONFIRMATORY TEST ASSAYS

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·FineTuner Echo

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·VIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME SYSTEM,PARADIGM REAL-TIME REVEL SYSTEM

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MINIMED 530G SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·CentriMag Circulatory Support System

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Oxford™ Cementless Partial Knee System

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·SOUNDTEC DIRECT SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX APEX EXIMER LASER WORKSTATION

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Aesculap activL Artificial Disc

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MYOPORE SUTURELESS MYOCARDIAL PACING LEAD