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

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    Electrical Stimulator System

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814640·GENUMEDI SILVER SIZE I

    PureLife+ Air/Water Syringe Tips

    FDA UDI
    PURELIFE, LLC·D79011922011·PureLife+ Air/Water Syringe Tips, Assorted Colo...

    ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOURS LAPIDUS PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·March 3, 2020

    COMPLETE SE ILIAC

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIO·February 21, 2017

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    FDA Adverse Event
    Injury ·COVIDIEN·Product code FGE·February 21, 2017

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 22, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; 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; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

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

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021