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

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, 2 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Sys

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE PRIME Everolimus Eluting Coronary Stent System / SV / LL ; XIENCE Xpedition Everolimus Eluting Coronary Stent Sys

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Proo Delivery Catheter Sys

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Sys

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·FLEX34 Active Electrode, Insertion Electrode (IE) FLEX34, Insertion Probe, Insertion Probe L and Auditory Nerve Test Sys

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Core Valve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Valve EnVeo R Delivery Catheter Sys

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EFH-16; S60-K; S 60-J; S 60-S

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ENDURANT AND ENDURANT II STENT SYSTEM, ENDURANT II AORTO-UNI-LLIAC(AUI) STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EFH-16; S 60-K; S 60-J; S 60-S

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·Mater Water Vapor System - Model # GEA-SYS-16-0500, Mara Water Vapor Probe Kit - Model # DDK-16-050, Mara Console - Mode