BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Apex Locator, DPEX III

    FDA 510(k)
    FDA Unclassified ·Unknown

    REPROCESSED RESTEP COMPRESSION SLEEVES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOUNDATION

    FDA 510(k)
    FDA Class 2 ·Dental

    DR FOG TREATED SPONGE, STERILE

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code OCT·September 16, 2020

    AFX SYSTEM

    FDA Adverse Event
    Death ·ENDOLOGIX, INC.·Product code MIH·June 20, 2013

    TRAY, FOLEY, BARDEX I.C. TEMPERATURE SENSING INFECTION CONTR

    FDA Adverse Event
    Malfunction ·BARD·Product code KOD·July 14, 2011

    PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE

    FDA Adverse Event
    Malfunction ·HOSPIRA DE COSTA RICA LTD.·Product code FPA·September 29, 2008

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019

    Ingenia 1.5T S-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 Model: 781347

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