BEUDAMED
    10,000 results · 48ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAYANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK P2, VENTAK P3

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·RESTOREULTRA IMPLANTABLE NEUROSTIMULATOR

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Algovita Spinal Cord Stimulation System

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Myocardial Pacing Lead

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReStor Posterior Chamber Intraocular Lenses

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS TAQMAN HBV TEST

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·DUROLANE

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HBV

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·COAPTITE

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

    Stimulator, Autonomic Nerve, Implanted (Depression)

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY SYSTEM

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY

    Stimulator, Autonomic Nerve, Implanted (Depression)

    FDA Pre-Market Approval
    FDA Class 3 ·PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MAXIMOII ICD

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·COLLACOTE ABSORABLE COLLAGEN WOUND DRESSING