BEUDAMED
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    regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025