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

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD

    Coronary Drug-Eluting Stent

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

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·THE HEART LASER CO2 TMR SYSTEM

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Lap-Band Adjustable Gastric Banding System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Corox OTW BP

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 PharmDx

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® CARDIOFORM ASD Occluder

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·ARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·SOLESTA

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL Pleural Air Leak Sealant

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·Puregraft Serene Breast Implant

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Optune System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RESTYLANE INJECTABLE GEL

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·SOLESTA INJECTABLE GEL

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·BRYAN Cervical Disc