BEUDAMED
    77 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

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

    FDA Pre-Market Approval
    FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Ceramax Ceramic Total Hip System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Ceramax Ceramic Total Hip System

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·PROTEGE GPS STENT SYSTEM

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems

    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    FDA Pre-Market Approval
    FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac)

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PROTEGE GPS/RX CAROTID STENT SYSTEMS

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé GPS Self Expanding Peripheral Stent System

    Stent, Carotid

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

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·PROTEGE GPS & RX CAROTID STENT SYSTEMS

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé GPS Self-Expanding Peripheral Stent System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protégé™ GPS™ Self-Expanding Peripheral Stent System