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

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·Gynecare Interceed™ Absorbable Adhesion Barrier

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

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

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG and Relia IPG

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

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

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LifePulse High Frequency Ventilator

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Perclose ProStyle Suture-Mediated Closure and Repair System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Coronary Stent System

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·SenTiva™ Generator, SenTiva Duo™ Generator

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Lead

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe™ Delivery System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta CRT-P C4TR01; Syncra CRT-P C2TR01

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBSAG QUALITTATIVE/CONFIRMATORY