BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    TEMPUS PRO WITH ENHANCED FEATURES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AEQUALIS

    FDA Adverse Event
    Injury ·TORNIER SAS·Product code KWS·May 23, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 20, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDF·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD.·Product code FCX·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDS·July 22, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015