BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471149878·K-WIRE - DOUBLE TROCAR FULLY THREADED 2.0mm DIA...

    DRILL SLEEVE F. SOLID STEPDRILL

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·February 23, 2012

    ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    CARDIOMET 4000 GAS MONITORING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·February 14, 2013

    HARMONIC ACE 23CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·January 17, 2011

    FREESTYLE INSULINX

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·July 28, 2014

    1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010