BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    CHROMID CARBA agar (CARB)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 7, 2022

    VYPRO-MESH II

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code FTL·June 20, 2013

    NDEHP LS TWN 2CLVE

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD·Product code FPA·July 7, 2011

    MITEK EXPRESSEW SUTURE PASSER

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·September 29, 2008

    SenTec Membrane Changer Insert [5 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

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017