BEUDAMED
    10,000 results · 32ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 530G System

    Coronary Drug-Eluting Stent

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters

    Stent, Renal

    FDA Pre-Market Approval
    FDA Class 3 ·RX Herculink Elite Renal and Biliary Stent System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/ Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 530G Insulin Pump

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·COMPLETE SE VASCULAR STENT SYSTEM

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Vascular Closure System (VCS)

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HBV

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·Tecnis 3-Piece Multifocal IOL

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    FDA Pre-Market Approval
    FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Sapien XT Transcatheter Heart Valve

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System, TECNIS® OptiBlue™ 1-Piece IOL with TECNIS Simplicity™ Deliv

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MINIMED 530G SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G5 Mobile Continuous Glucose Monitoring System

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·eCoin (Electroceutical Coin)