BEUDAMED
    6,778 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF CRT-D SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity+, Endurity, Accent family of Pacemakers

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ Tonic Lenses

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

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Sense Lead, Vitatron Crystalline Lead

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra AV TPS, Micra TPS

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra AV TPS, Micra TPS

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

    FDA Pre-Market Approval
    FDA Class 3 ·Concerto ICD, Concerto II CRT-D, Conslta DR4 ICD, Consulta ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Prot

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP

    Enzyme Immunoassay, Fetal Fibronectin

    FDA Pre-Market Approval
    FDA Class 3 ·Rapid fFN for the TLiIQ System

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·LEGEND PLUS

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic