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

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    CONTEC Oxygen Concentrator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    PACENTRIC CONNECT, TRAVELER AND WEB

    FDA 510(k)
    FDA Class 2 ·Radiology

    XPERT MRSA/SA SSTI ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 20, 2013

    NEONATAL HEATED-WIRE CIRCUITS

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·April 28, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA.·Product code LFR·September 23, 2008

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024

    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