BEUDAMED
    3,089 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·Amplatzer™ Muscular VSD Occluder

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·PROGRAMMER TO SUPPORT VARIOUS PACEMAKERS & DEFIBRILLATORS

    System, Endovascular Graft, Aortic Aneurysm Treatment

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

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate 4000 (“Neuro”) Type 1.0 & 1.1

    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