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

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    3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIPOSONIX SYSTEM, MODEL 1 P00XXXX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·June 20, 2013

    54CM BIPOLAR LEAD

    FDA Adverse Event
    Injury ·GREATBATCH MEDICAL·Product code DTB·July 19, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 17, 2014

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    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