BEUDAMED
    10,000 results · 50ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·THINLINE/FINELINE LEADS AND ACCESSORIES

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CEEON & TECNIS UV-ABORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

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

    FDA Pre-Market Approval
    FDA Class 3 ·MERLIN PATIENT CARE SYSTEM ACCESSORIES

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM,PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE DERMAL FILLER

    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·OXFORD PARTIAL KNEE SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chilli II Cooled Catheter, Sterile Cables, Tubing Kit

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire Model 3028 Implantable Pulse Generator (IPG)

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, and Intica Neo 5

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC ICD MODEL 7272