BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    uOmnispace

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD INTIMA II¿ IV CATHETER 24 G X 0.75 IN.

    FDA Adverse Event
    Injury ·BD (SUZHOU)·Product code FOZ·February 16, 2017

    PATHWAY STM-10 PELVIC FLOOR STIMULATOR

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

    REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

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

    CRYSTALENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB SURGICAL·Product code HQL·November 12, 2008

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 31, 2011

    MP70 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code DSI·July 12, 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