BEUDAMED
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    IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS IMPRESSION BARREL

    FDA 510(k)
    FDA Class 1 ·Dental

    CHARTER LABORATORIES INC. LENS LUBRICANT

    FDA 510(k)
    FDA Unclassified ·Unknown

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON - BELGIUM/ ALCON N.V.·Product code KYG·May 8, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·February 15, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIV.·Product code FNL·January 12, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NPT·November 3, 2025

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024