BEUDAMED
    2,784 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

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

    FDA Pre-Market Approval
    FDA Class 3 ·VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems, Pisces, Specify, and Vectris Spinal Cord Stimulati

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·THINLINE/FINELINE ENDOCARDIAL PACING LEADS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 411

    Ventilator, High Frequency

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

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SUPARTZ FX, VISCO-3

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Wrench

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Restore, Itrel, Synergy, Intellis, Vanta, Sequentia LT, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris

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

    FDA Pre-Market Approval
    FDA Class 3 ·ANTI-HBCM IMMULITE ASSAY

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Bowel)

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable System for Remodulin

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI

    Sensor, Glucose, Invasive

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Accessory, Stabilizer

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US