BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    TOSHIBA, SMIT ROENTGEN

    FDA 510(k)
    FDA Class 1 ·Radiology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700744·GC Initial™ MC Clear Fluorescence CL-F, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700711·GC Initial™ MC Clear Fluorescence CL-F, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·10888867335179·Guidewire, .062" (1.6 mm), Trocar

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024551046·

    Persona®

    FDA UDI
    Zimmer, Inc.·00889024550957·

    OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LASTAC SYSTEM

    VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 12, 2014

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 15, 2010

    FENESTRATED BIPOLAR FORCEPS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·December 10, 2012

    IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imaging data viewing.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014