BEUDAMED
    2,546 results · 31ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

    Light Source System, Diagnostic Endoscopic

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·R Series MCU 20.01 software release

    System, Imaging, Fluorescence

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands, RADIESSE® (+) Lidocaine, RADIESSE (+) Jawline

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·PerClot Polysaccharide Hemostatic System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Restylane Injectable Gel

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MEMORYGEL BREAST IMPLANT

    System, Laser, Fiber Optic, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·Optiguide Cylindrical Fiber Optic

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·COHERENT OPAL PHOTOACTIVATOR

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RHA 3

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE® Family of Injectable Gels

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

    System, Laser, Fiber Optic, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·HEMOBLAST™ Bellows

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Silicone Gel Breast Implants