BEUDAMED
    825 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·RF ENCHANCER II ABLATION CATHETER

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·PRISMAFLEX TPE 2000 Set

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve™ EnVeo™ R Delivery Catheter System, CoreValve™ EnVeo™ PRO Delivery Catheter System, Evolut™ PRO+ Delivery Cath

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC SELECTSECURE MODEL 3830 LEAD

    Coronary Drug-Eluting Stent

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

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Allure Quadra

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System – RX and OTW

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·O2OPTIX/AIR OPTIX AQUA/AIR OPTIX FOR ASTIGMATISM/AIR OPTIX AQUA MULTIFOCAL

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity Spyral™ Renal Denervation System

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·Oxford Partial Knee System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus