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

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi

    Implant, Intragastric For Morbid Obesity

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

    Cardiac Ablation Percutaneous Catheter

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

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chilli II Cooled Ablation Catheter and Cable

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·NUVASIVE PCM CERVICAL DISC SYSTEM

    Kit, Rna Detection, Human Papillomavirus

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

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Touch Dispenser

    System, Oxygen, Aqueous

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

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses

    Sensor, Glucose, Invasive

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

    Optoacoustic Imaging System

    FDA Pre-Market Approval
    FDA Class 3 ·Imagio® Breast Imaging system

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·DERMAGRAFT (HUMAN FIBROBLAST -DERIVED DERMAL SUBSTITUTE)

    Sensor, Electro-Optical (For Cervical Cancer)

    FDA Pre-Market Approval
    FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

    Sensor, Glucose, Invasive

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

    Lenses, Soft Contact, Extended Wear

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

    Implant, Intragastric For Morbid Obesity

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

    Cardiac Ablation Percutaneous Catheter

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

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent inject W Trabecular Micro-Bypass System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·COMFILCON A EXTENDED WEAR-LENSES

    Analyzer, Diagnostic, Fiber Optic (Colon)

    FDA Pre-Market Approval
    FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM