BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Ventricular (Assist) Bypass

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE 2000 XPI ANTI-HBC IMG

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T-SPOT. TB TEST

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·THE NORMALINE KIT

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·THE NORMALINE KIT

    Wheelchair, Stair Climbing

    FDA Pre-Market Approval
    FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

    Wheelchair, Stair Climbing

    FDA Pre-Market Approval
    FDA Class 2 ·ACCESS MOBILITY SYSTEM

    System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Pre-Market Approval
    FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

    Wheelchair, Stair Climbing

    FDA Pre-Market Approval
    FDA Class 2 ·ACCESS MOBILITY SYSTEM

    System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Pre-Market Approval
    FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

    Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses

    FDA Pre-Market Approval
    FDA Class 3 ·PLASMA SEPARATION SYSTEM

    System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Pre-Market Approval
    FDA Class 2 ·ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM

    Wheelchair, Stair Climbing

    FDA Pre-Market Approval
    FDA Class 2 ·INDEPENDENCE IBOT 3000 MOBILITY SYSTEM

    Wheelchair, Stair Climbing

    FDA Pre-Market Approval
    FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM Hepatitis B Core Antigen (aHBcM) Assay, Atellica IM He

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T SPOT-TB TEST