BEUDAMED
    10,000 results · 51ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Origen, Dynagen, Inogen EL ICD; Origen, Dynagen, Inogen MINI ICD

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK RX ULTRA™ Coronary Stent System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Tendril MRI

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

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Aveir™ Delivery Catheter

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HiResolution Bionic Ear System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE PRO RX Nitinol Stent System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon lntraocular Lenses with the AutonoMe Delivery System

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad

    Replacement Heart-Valve

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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé™ GPS™ Self-Expanding Peripheral Stent System, Protégé™ RX Carotid Stent System

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen LPS-Flex / LPS-Mobile Bearing Knee

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

    FDA Pre-Market Approval
    FDA Class 3 ·Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet (MR Conditio

    Stent, Superficial Femoral Artery, Drug-Eluting

    FDA Pre-Market Approval
    FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Aurora EV-ICD System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 400 DR/SR IPG