BEUDAMED
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    FDA Pre-Market Approval
    GEM DR, GEM II VR, GEM II DR, AND GEM III IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEM & GEM II VR

    EliA ANCA/GBM Positive Control 2500/5000

    FDA UDI
    Phadia AB·07333066013152·EliA ANCA/GBM Positive Control 2500/5000

    QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

    FDA 510(k)
    FDA Class 2 ·Immunology

    COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

    FDA 510(k)
    FDA Class 2 ·Immunology

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEM III DR 7275, GEM III VR 7231, GEM DR 7271

    SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD

    FDA 510(k)
    FDA Class 1 ·Dental

    Model 2004 Maestro Implant Kit

    FDA UDI
    Reshape Lifesciences Inc.·00857334004279·The Model 2004 Implant Kit consists of a Model ...

    Formthotics

    FDA UDI
    FOOT SCIENCE INTERNATIONAL LIMITED·09419430004464·Firm Extended Wedges Self Adhesive - M

    Formthotics

    FDA UDI
    FOOT SCIENCE INTERNATIONAL LIMITED·09419430003955·Firm Rearfoot Wedges Plain - M

    Formthotics

    FDA UDI
    FOOT SCIENCE INTERNATIONAL LIMITED·09419430004433·Firm Rearfoot Wedges Self Adhesive - M

    Formthotics

    FDA UDI
    FOOT SCIENCE INTERNATIONAL LIMITED·09419430003986·Firm Extended Wedges Plain - M

    FDA Pre-Market Approval
    GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS

    Personal KinetiGraph (PKG)

    FDA UDI
    GKC MANUFACTURING PTY LTD·09359011000280·The Personal KinetiGraph (PKG) is intended to q...

    Personal Kinetigraph (PKG)

    FDA UDI
    GKC MANUFACTURING PTY LTD·09369998107773·The Personal Kinetigraph (PKG) is intended to q...

    Personal KinetiGraph (PKG)

    FDA UDI
    GKC MANUFACTURING PTY LTD·09359011000310·The PKG Smart Charger is a portable charging st...

    Personal KinetiGraph (PKG)

    FDA UDI
    GKC MANUFACTURING PTY LTD·09359011000327·The PKG Smart Charger is a portable charging st...

    Personal KinetiGraph (PKG)

    FDA UDI
    GKC MANUFACTURING PTY LTD·09359011000297·The PKG Smart Charger is a portable charging st...