BEUDAMED
    3,169 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Aveir™ VR Leadless Pacemaker, Aveir™ DR Leadless Pacemaker

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·EVOLENCE COLLAGEN FILLER

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biomedics Toric/ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·activL Artifical Disc

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    FDA Pre-Market Approval
    FDA Class 3 ·Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE Sierra Everolimus Eluting Coronary Stent System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLogic™

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MIRACLIP CLIP DELIVERY SYSTEM

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Livewire™ TC XLS™ Ablation Catheter, Livewire™ TC XLS™ Bi-Directional Ablation Catheter, Livewire™ TC Catheter Extension

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

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS

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

    FDA Pre-Market Approval
    FDA Class 3 ·HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT