BEUDAMED
    1,962 results · 23ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·ONYX LIQUID EMBOLIC SYSTEM

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense®

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    FDA Pre-Market Approval
    FDA Class 3 ·Parvovirus B19 IgG Enzyme Immunoassay

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·8-Channel Adapters

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    FDA Pre-Market Approval
    FDA Class 3 ·Parvovirus B19 IgM Enzyme Immunoassay

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC TOTAL ASSAY

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed™ Infusion System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T-SPOT ®.TB

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY PULSE GENERATOR, LEAD AND PATIENT KIT

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON - TB Gold Test and TB Gold Plus Test

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Torque Wrench

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

    Tympanostomy Tube Delivery Product With Drug

    FDA Pre-Market Approval
    FDA Class 3 ·Tula® System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·AEGEA Vapor System, AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, AEGEA Vapor Generator Accessory Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE VDD 2 LEAD,PRODIGY IPG,SERVICE KIT-PACEMAKER REPAIR KIT,VITATRON BRILLIANT S+ VDD LEAD