BEUDAMED
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    OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112694·BARRON CORNEAL PUNCH 9.5MM

    MICROVASIVE LITHOTRIPTOR FLEXPROBE II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STIMPOD NMS450 NERVE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TAXUS® LIBERTÉ®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 8, 2013

    TOTAL ASR ACET IMP SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·November 10, 2010

    COMPRESSOR MINI

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code BTI·February 24, 2014

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013