BEUDAMED
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    MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799004284·

    P.F.C. SIGMA

    FDA UDI
    DEPUY (IRELAND)·10603295241003·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING CURVED...

    Ambler Surgical

    FDA UDI
    AMBLER SURGICAL CORP.·10190660200029·MICS Slit knife, 2.0mm wide, angled blade, full...

    URASSIST

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    M.U.S.T. Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·February 14, 2013

    PROMUS PREMIER?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 28, 2014

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·January 17, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 27, 2015

    PEDICLE SCREW LATERAL CONNECTOR L150

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023

    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017