BEUDAMED
    10,000 results · 36ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR

    Bone Grafting Material, Dental, With Biologic Component

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE Bone Graft

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/ Quadrip

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella CP with SmartAssist

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·RF Conductr MC; RF Marinr 5Fr; RF Marinr 7Fr; and Unipolar Mapping RF Marinr 7Fr

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·PSW 2201.U/1 and NEO 2201.U/1

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

    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 ·Sprint Quattro Lead

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Astron

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus

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

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-EBK PLUS

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CONSULTA CRT-P & SYNCRA CRT-P

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, MODEL 4195 ATTAIN SUREFIX LEAD

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense TM