BEUDAMED
    29 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip Delivery System

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Epi proColon

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Cardiva VASCADE VCS

    Prosthesis, Intervertebral Disc

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

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Mobi-C Cervical Disc Prosthesis for use at One or Two Levels

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY LEAD

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY SPIRAL LEAD, ACUITY X4 LEAD

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE LEAD

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Monitor, Lung Water Measurement

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

    Monitor, Lung Water Measurement

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FRx Defibrillator

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart FR3 Defibrillator

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER