BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    STRATUS ESTRADIOL FLUOREMETRIC ENZYME

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756349598·CARDIAC CATH PACK

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Best Glove-Nitrile Powder Free Examination Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

    130 DEG AIMING ARM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·September 2, 2021

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL- NEUROMODULATION DIV·Product code LGW·November 18, 2010

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·July 2, 2014

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·December 19, 2012

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·H10·Product code KWP·April 4, 2013

    NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·July 30, 2014