BEUDAMED
    66 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROPEL

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL® Absorbable Hemostats

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·Adherus AutoSpray Dural and ET Dural Sealant

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA™ Implant System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA™ System

    Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

    FDA Pre-Market Approval
    FDA Class 3 ·OPRA Implant System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge