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

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MAXIM PFS MODEL 033-301

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationFocus CDxBRCA

    Stimulator, Functional Neuromuscular, Scoliosis

    FDA Pre-Market Approval
    FDA Class 3 ·SCOLITRON(TM) STIMULATOR

    Cap, Cooling (Infants)

    FDA Pre-Market Approval
    FDA Class 3 ·OLYMPIC COOL-CAP

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·KONTUR 55 EW

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OMNISCEINCE PROSTHETIC CARDIAC VALVE

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

    Stimulator, Fetal, Acoustic

    FDA Pre-Market Approval
    FDA Class 3 ·FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·CDS II (SODIUM CHONDROITIN SULFATE)

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

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTION ctDx FIRST

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FINISHED METHAFILCON A CONTACT LENSES

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT

    Occluder, Internal Vessel, Temporary

    FDA Pre-Market Approval
    FDA Class 3 ·LEGOO

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX EXCIMER LASER SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

    Tissue Graft Of 6mm And Greater

    FDA Pre-Market Approval
    FDA Class 3 ·DARDIK BIOGRAFT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·URYX URETHRAL BULKING AGENT