BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    EYE PROCEDURE PACK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376677040·Proximity 3-Level ACP, 40 mm

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587673·Apex Femoral Nail Retrograde Ø 8.5 x 340mm

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529586775·Apex Femoral Nail GT Right Ø 8.5 x 340mm

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585877·Apex Femoral Nail GT Left Ø 8.5 x 340mm

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529580919·Apex Femoral Nail PF Left Ø 8.5 x 340mm

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529581923·Apex Femoral Nail PF Right Ø 8.5 x 340mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376677071·Proximity 3-Level ACP, 40 mm

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376677057·Proximity 3-Level X-Lordotic ACP, 40 mm

    MICROMEDICS SPHENOID SINUS STENT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376677064·Proximity 3-Level X-Lordotic ACP, 40 mm

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 26, 2012

    AUTOCLAVEABLE INTERNAL HANDLES (MSERIES)

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·March 17, 2014

    PIN TO ROD COUPLING HOFFMANN II MRI 4-5/8MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code KTT·September 20, 2010

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018