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

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·MOBILEXCIMER FOR PTK AND PRK

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·QUIK-PAK Electrodes

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·QUIK-PAK™ Electrodes

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·QUIK-PAK Electrodes

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine samaritan® Public Access Automated External Defibrillators and Accessories

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Perceval PLUS Sutureless Heart Valve

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOLECTRON ORTHO-PAK BONE GROWTH STIMULATOR/SPINALPAK SPINAL FUSION STIMULATOR

    Mr-Guided Focused Ultrasound System

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

    LIFE PAK 12

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    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)