BEUDAMED
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    SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Glenoid Baseplate with Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NOTINGHM SHLDR HUM HEAD 48X17 OFFSET

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWS·January 19, 2016

    SEE H-10

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·March 7, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

    CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

    CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

    CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·February 12, 2013

    COD.712 TOP CIRC.RACC.CARDIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTN·December 15, 2011

    Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).

    FDA Recall
    Open, Classified ·Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China·Product code JAK·May 23, 2020

    uCT 760 System, Computed Tomography X-ray System

    FDA Recall
    Terminated ·Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China·Product code JAK·May 8, 2020

    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

    FDA Recall
    Terminated ·Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China·Product code KPR·July 30, 2019

    Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is 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 Recall
    Terminated ·Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China·Product code KPS·August 26, 2019

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

    FDA Recall
    Open, Classified ·UIH Technologies LLC·Product code JAK·September 12, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

    FDA Recall
    Open, Classified ·UIH Technologies LLC·Product code JAK·September 12, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

    FDA Recall
    Open, Classified ·UIH Technologies LLC·Product code JAK·September 12, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

    FDA Recall
    Open, Classified ·UIH Technologies LLC·Product code JAK·September 12, 2025