BEUDAMED
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    Disposable Hemoclip

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

    LessRay

    FDA UDI
    Nuvasive, Inc.·00887517732699·LessRay Computer Enclosure

    BENCO

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975035271·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707022633·CALIBRA BANDS 2ND MOLAR n.SUL 4

    Universal Dilator

    FDA UDI
    SPINEOLOGY INC.·M7405230004·Tightener

    Greenwald Surgical Company, Inc.

    FDA UDI
    GRACE MANUFACTURING, INC.·10801334013325·STORZ S/S SPIKED ROLLER ELECTRODE Model # ...

    0.55% ORTH-PHTHALALDEHYDE SOLUTION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

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

    BD FLASHBACK BLOOD COLLECTION NEEDLES 21G X 1"

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code JKA·November 5, 2017

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 12, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 31, 2011

    DELTA CER HEAD 12/14 32MM +5

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LZO·July 16, 2013

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 6, 2021

    Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·November 18, 2020

    Positron Emission Tomography and Computed Tomography System, Model: uMI 550

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022

    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