BEUDAMED
    10,000 results · 31ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MedEl EAS System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Mi1210 SYNCHRONY ST Cochlear Implant

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·SONNET 3 (EAS) Audio Processor, MAESTRO 11

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM

    Tester, Acoustic, Bone Quality

    FDA Pre-Market Approval
    FDA Class 3 ·QUS-2 CALCANEAL ULTRASONOMETER

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EPT-1000 CARDIAC ABLATION SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERA

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL

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

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR,

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·TRYTON Side Branch Stent

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI ICD DR, MOMENTUM™ EL ICD VR, MOMENTUM™ EL

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

    FDA Pre-Market Approval
    FDA Class 3 ·MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, VIGIL

    Implantable Cardioverter Defibrillator (Non-Crt)

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

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·enVista Hydrophobic Acrylic Intraocular Lens