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

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

    FDA Pre-Market Approval
    FDA Class 3 ·PathVysion HER-2 DA Probe Kit

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD)

    PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD)

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE FILLED BREAST IMPLANTS

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SALINE FILLED BREAST IMPLANT

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD); Orbital Atherectomy System Pump (OAS Pump)ViperWire Advance C

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

    Implant, Anti-Gastroesophageal Reflux

    FDA Pre-Market Approval
    FDA Class 3 ·LINX Reflux Management System

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TORONTO SPV VALVE

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE® Silicone-Filled Breast Implants

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

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON®XL MUREX Anti-HBc assay and Control