BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    DR. BOO POWDER-FREE LATEX EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377072351·RELINE C Ti Rod, 3.5x240mm Straight

    SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

    FDA 510(k)
    FDA Class 2 ·Hematology

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code BTR·August 17, 2016

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·January 18, 2013

    TERUMO STERNAL SAW II

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·December 22, 2010

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 17, 2014

    PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014