BEUDAMED
    10,000 results · 35ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta , Syncra and Viva CRT-P

    Mr-Guided Focused Ultrasound System

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

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON QuantiFERON TB Gold Plus

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IntellaNav ST

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve Evolut R and Evolut PRO System

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NexGen® LPS-Flex / LPS-Mobile Bearing Knee

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Talent Occluder With Occluder Delivery System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Tendril STS, UltiPace

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Symplicity G3™ Renal Devervation RF Generator

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR, -T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T D

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Coronary Drug-Eluting Stent

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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL CAPSUREFIX 6940

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSARCI100 COCHLEAR IMPLANT

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK AV FAMILY (INCLUDES PRIZM AND VITALITY FAMILIES)

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·KRONOS LV-T CRT-D

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·GENESYS HTA SYSTEM