BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    AIRSTRIP REMOTE PATIENT MONITORING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169606142·SPACER 2133450 OLIF25 27MM 18 DEG 14X50

    HHM

    FDA UDI
    Oticon A/S·05707131261243·H110, BTE 13 WL 85 CNB HHM

    CELL-DYN EMERALD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·June 11, 2018

    FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PHONAK TINNITUS BALANCE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    INSIGNIA

    FDA Adverse Event
    Death ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·June 20, 2011

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·August 22, 2008

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    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