BEUDAMED
    10,000 results · 34ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Ultra (samfilcon A) Contact Lens

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE® Injectable Implant

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Acrysof IQ Aspheric UV absorbing IOL with the UltraSert Pre-Loaded Delivery System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Voluma XC for Chin Augmentation

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·EMDOGAIN

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·UVAR PHOTOPHORESIS SYSTEM

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM MODEL 3023 AND TRANSCEND MODEL 3726 IMPLANTABLE NEUROSTIMULATORS

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Navion Thoracic Stent Graft System

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScaan Lead and Sprint Quattro MRI SureScan Lead

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC DUAL CHAMBER PACEMAKERS