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

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    TOA

    FDA 510(k)
    FDA Class 2 ·Dental

    artegral

    FDA UDI
    Merz Dental GmbH·D7091972061·posteriors; shade B2; size XL; lower jaw

    MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PRECICE UNYTE System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRULIANT TIB IMP PS INSERT SZ 4.5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 26, 2024

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·January 22, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·January 27, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 31, 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