BEUDAMED
    114 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM; SPINAL PAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM

    SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune Gio

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune System

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune®

    Tissue Adhesive For Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOTFF-100A SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOTTF-100A SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVA TTF-100A SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE'S OPTUNE SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOTTF-100A SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE NOVOTTF-100A SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune System

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune System

    Tissue Adhesive For Internal Use

    FDA Pre-Market Approval
    FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOTTF-100A TREATMENT KIT