BEUDAMED
    969 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

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

    Kit, Rna Detection, Human Papillomavirus

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

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Controller, Closed-Loop, Blood-Pressure

    FDA Pre-Market Approval
    FDA Class 3 ·TITRATOR{TM} MODEL 10K

    Implant, Intragastric For Morbid Obesity

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Praxis (MiSeqDx) Extended RAS Panel

    System, Oxygen, Aqueous

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

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

    Lenses, Soft Contact, Extended Wear

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

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV ASSAY

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

    Sensor, Glucose, Invasive

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

    Implant, Intragastric For Morbid Obesity

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

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Natural Eyes HydraWear™ XW Multifocal

    Lenses, Soft Contact, Extended Wear

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

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Toric

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac

    Intraocular Pressure Lowering Implant

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

    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

    FDA Pre-Market Approval
    FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System