BEUDAMED
    2,328 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIMUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATIN

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY SYSTEM

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

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

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

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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·S-ICD SYSTEM

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Essentio SR, Essentio DR, Essentio EL DR, Proponent SR, Proponent DR, Proponent EL DR, Accolade SR, Accolade DR, Accola

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

    FDA Pre-Market Approval
    FDA Class 3 ·MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, VIGIL

    System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ColoSense

    Implanted Brain Stimulator For Epilepsy

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ESSENTIO™ MRI SR, ESSENTIO™ MRI DR, ESSENTIO™ MRI EL DR, PROPONENT, ACCOLADE™ MRI SR, ACCOLADE™ MRI DR, ACCOLADE™ MRI EL

    Implantable Cardioverter Defibrillator (Non-Crt)

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

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·DRUG DELIVERY INFUSION

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·POLYMACON EXTENDED WEAR LENSES

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT FREE PSA

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Novus Lead

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS® CL Foldable Silicone Posterior Chamber IOL