BEUDAMED
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    Medical Diode Laser Systems

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRISMAFLEX

    FDA Adverse Event
    Malfunction ·GAMBRO LUNDIA AB·Product code KDI·June 7, 2024

    FREEDOM CONSTRAINED LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ExcelsiusGPS Cranial 1.0 Module

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD ULTRA-FINE¿ PEN NEEDLE 32G X 4MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 15, 2016

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·August 31, 2011

    COMFORT

    FDA Adverse Event
    Other ·M.C. HEALTHCARE PRODUCTS A DIVISION OF SPAN MEDICAL PRODUCTS CANADA INC·Product code FNL·July 11, 2013

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025