BEUDAMED
    1,014 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chilli II Cooled RF Ablation system

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HPV Assay

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·ReShape Lap-Band System

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

    Stent Graft, Infrapopliteal, Venous Arterialization

    FDA Pre-Market Approval
    FDA Class 3 ·LimFlow System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM CGM

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI COOLED RPM CATHETER

    System, Oxygen, Aqueous

    FDA Pre-Market Approval
    FDA Class 3 ·TherOx Downstream System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Toric

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere

    Stent Graft, Infrapopliteal, Venous Arterialization

    FDA Pre-Market Approval
    FDA Class 3 ·LimFlow System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)