BEUDAMED
    14 results · 30ms · Sources: EU EUDAMED, US FDA

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    MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190653·Femoral Sizing Guide Bushing 3 deg

    CHARNLEY

    FDA UDI
    DEPUY INTERNATIONAL LTD·10603295240501·CHARNLEY WEIGHT AND 24 INCHES CHAIN

    ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    1.5T and 3.0T 16 CH GE Shoulder Coils

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 23, 2019

    SCREW,FIXATION,BONE

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

    QUANTUM¿ MAVERICK¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·February 14, 2013

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 17, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code IKX·July 28, 2014

    SCREW, FIXATION, BONE

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

    TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°

    FDA Adverse Event
    Death ·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015

    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

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·August 22, 2018