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

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    FIBRINOGEN CONTROL PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    OSTEOSYMBIONICS, ST TEMPORALIS IMPLANT

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

    AQUASENS FLUID MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 2, 2015

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024