BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    CRW STEREOTACTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024664·B-P MODULAR EXTENSION W/ULTRACOAT - 11 MM X 200 MM

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·June 29, 2017

    OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 7, 2011

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 15, 2016

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024