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

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    IOGYN ENDOSCOPE

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

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·04026704541751·PVC NASOPHARYNGEAL AIRWAY STERILE

    AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 33cm x 130°

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016659·

    NEUFLEX

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295017912·NEUFLEX FINGER-PIP IMPLANT 3 CEMENTLESS

    BRIVO MR355, OPTIMA MR360

    FDA 510(k)
    FDA Class 2 ·Radiology

    BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 23, 2023

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

    MAESTRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·June 8, 2011

    10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330) The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355/ Optima MR360 reflect the spatial distribution or molecular environment of 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