BEUDAMED
    10,000 results · 32ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·BETA-CATH(TM)SYSTEM

    Ventricular (Assist) Bypass

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Bioprosthesis

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate II Left Ventricular Assist System

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·enVista One-Piece Foldable Acrylic Intraocular Lens (IOL)

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·QuickFlex µ, Quartet

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas® HPV

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

    Ventricular (Assist) Bypass

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

    Prosthesis, Spinous Process Spacer/Plate

    FDA Pre-Market Approval
    FDA Class 3 ·Superion Indirect Decompression System

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·NuVasive PCM Cervical Disc

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ACS MULTI-LINK RX DUET & ACS MULTI-LINK OTW DUET CORONARY STENT SYSTEMS

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

    Extended Depth Of Focus Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IC-8® Apthera™ Intraocular Lens (IOL)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NeuroPac RNS System