BEUDAMED
    15 results · 33ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR Connecting and Extension Sets

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Saluda Medical Evoke® SCS System

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·Sphere-9™ Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable System for Remodulin (ISR)

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator

    Stent Graft, Infrapopliteal, Venous Arterialization

    FDA Pre-Market Approval
    FDA Class 3 ·LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft

    Stent Graft, Infrapopliteal, Venous Arterialization

    FDA Pre-Market Approval
    FDA Class 3 ·LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TREO Abdominal Stent-Graft System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM