BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·June 2, 2021

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    FDA Enforcement
    Class II ·Terminated·Gibson Bioscience·September 22, 2021

    Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

    FDA Enforcement
    Class II ·Terminated·Rocket Medical Plc·December 4, 2019

    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·June 17, 2015

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019