BEUDAMED
    10,000 results · 42ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer II, Blazer II HTD, Blazer Prime HTD

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE TAG Thoracic Branch Endoprosthesis (TBE Device)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Essentio MRI, Proponent MRI, Accolade MRI Pacemakers

    Leadless Pacemaker

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

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys total PSA Test System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK CR2 Defibrillator

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PHYSIO-STIM LITE BONE GROWTH STIMULATOR

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UP350 UV/ABSORBING POSTERIOR CHAMBER IOL

    Prosthesis, Ligament, Ptfe

    FDA Pre-Market Approval
    FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·TCI HEARTMATE(R) 1000A IP LVAD

    System, Esophageal Pacing

    FDA Pre-Market Approval
    FDA Class 3 ·TAPSCOPE 550

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·COCHLEAR C1500 SERIES IMPLANTS

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEXGEN LPS-FLEX/ LPS MOBILE BEARING KNEE SYSTEM

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENSES

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Home Monitoring System Version 3.52.0