BEUDAMED
    409 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·CELERITY,COROX,ENTOVIS HF(-T),EVIA HF (-T),STRATOS

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIO-SEAL Vascular Closure Devices

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO HERCEPTEST

    Stimulator, Autonomic Nerve, Implanted (Depression)

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY MODEL 302 LEAD

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·DEXTRUS,ECURO,EFFECTA,ESTELLA,EVIA,ENTOVIS,SELOX,SETROX S,SOLOX,TILDA

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS EXPRESS2 CORONARY STENT SYSTEM

    Mitral Valve Repair Devices

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

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VERIFLEX MONORAIN & OVER-THE-WIRE CORONARY STENT SYSTEM

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·ILESTO,IFORIA,LUMAX

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION)