BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    CAPILLARY'S HEMOGLOBIN(E) (PN 2007)

    FDA 510(k)
    FDA Class 2 ·Hematology

    ConMed Linvatec

    FDA UDI
    Provision·B504OM50522910·

    HALL

    FDA UDI
    Conmed Corporation·20845854000318·LARGE BONE HALL BLADE, RECIPROCATOR, 12.5 X 76 ...

    LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code CHI·March 4, 2011

    SYNCHRON VANCOMYCIN REAGENT

    FDA Adverse Event
    BECKMAN COULTER INC.·Product code LEH·June 10, 2011

    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA

    FDA 510(k)
    FDA Class 2 ·Immunology

    MOTOR-DRIVE MANIPULATOR MM-89

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

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 31, 2010

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 8, 2011

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

    5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems) Signa HDxt (K052293 Signa HDx and HDxt MR Systems ) The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDe MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa HDe system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 4, 2013

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 23, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 12, 2011

    HENRY SCHEIN

    FDA Adverse Event
    Malfunction ·A.R. MEDICOM INC. (SHANGHAI) LTD.·Product code FXX·December 12, 2016

    HENRY SCHEIN SOFT EARLOOP FACE MASK

    FDA Adverse Event
    Other ·A.R. MEDICOM·Product code FXX·July 27, 2012