BEUDAMED
    10,000 results · 35ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions 3D System High Resolution Tomosynthesis

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve™ Evolut™ R DCS (EnVeo R DCS), Medtronic CoreValve™ Evolut™ PRO DCS (EnVeo PRO DCS), Medtronic Evolut

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·TRIDYNE™ Vascular Sealant

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4 DR, Enticos 4

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·DEMA/DIVA IMPLANTABLE PULSE GENERATORS

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

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

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HPV 16/18 COMPONENTS

    Pulse Generator, Permanent, Implantable

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

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·TruSight Oncology Comprehensive

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FREQUENCY 55, FREQUENCY 55 ASPHERIC, FREQUENCY XCEL TORIC, FREQUENCY 55 TORIC

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Epicardial Pacing Lead

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC & INSYNC III

    Pulse Generator, Permanent, Implantable

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

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NeuroPace RNS System

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·AEGEA Vapor System