BEUDAMED
    10,000 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chilli II ™ Cooled Ablation Catheter and Cable

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Hancock II Bioprosthesis

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ellipse DR, Ellipse VR

    Implanted Brain Stimulator For Epilepsy

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accent MRI Pacemaker

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·BIOENTERICS LAP-BAND

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL TIME SYSTEM

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SPINALOGIC 1000 BONE GROWTH STIMULATOR

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ACS MULTI-LINK CORONARY STENT SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINTY/IDENTITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES