BEUDAMED
    4,992 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II Cardiac Ablation System and Cable

    Pulse-Generator, Single Chamber, Single

    FDA Pre-Market Approval
    FDA Class 3 ·INTERTACH

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·FLEXTEND LEADS

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Ophthalmic Viscosurgical Devices

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ALTRUA 2 /ESSENTIO/ PROPONENT/ ACCOLADE

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

    FDA Pre-Market Approval
    FDA Class 3 ·VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P

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

    FDA Pre-Market Approval
    FDA Class 3 ·NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY Distal Tip Laser Weld Process

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer PFO Occluder

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·1CDELS B-13F (P-10) & B-1H (P-11)

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™, A

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VARIOUS FAMILIES OF PULSE GENERATORS AND ACCESSORIES

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·COSMOS(TM) SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Single-Piece PMMA Posterior Chamber IOL

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Acuity Steerable Lead System