BEUDAMED
    144 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC IMPLANTABLE CARDIO-VERTER DEFIBRILLATOR SYSTEMS ENTRUST ICOS

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Sapien XT Transcatheter Heart Valve

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Intuity Elite Valve System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Sapien 3 Transcatheter Heart Valve and Ultra Transcatheter Heart Valve

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·DiamondTemp Ablation Catheters

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve™ Evolut™ R Transcatheter Aortic Valve, Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve,

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Avalus Bioprosthesis, Model 400

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    FDA Pre-Market Approval
    FDA Class 3 ·TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA VS-100 MP PC IO

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·SILIKON 1000

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL DR, L30

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·A209 SICD Gen 2, A219 SICD MRI

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, L31

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

    FDA Pre-Market Approval
    FDA Class 3 ·U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P

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

    FDA Pre-Market Approval
    FDA Class 3 ·G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN CRT-D,

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Spinal Cord Stimulation (SCS) Leads

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) Leads