BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    NEUROSTAR TMS THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574879·CoRoent Ant TLIF Ti, 13x13x40mm 8°

    HHM

    FDA UDI
    Oticon A/S·05707131262110·H110, RITE 312 WL DBL HHM

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959045941·DreamWear Full Mask, Medium Wide, with Medium F...

    BECTON DICKINSON

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·August 2, 2013

    POSTERIOR LATERAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Q. FREEZE (MOTION VUE2)

    FDA 510(k)
    FDA Class 2 ·Radiology

    BELIFU

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

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·May 29, 2013

    FREESTYLE BREAST PUMP

    FDA Adverse Event
    Injury ·MEDELA AG·Product code HGX·June 15, 2011

    MODULAR ANALYTICS CORE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 22, 2008

    Philips Respironics DreamWear Full Face Mask

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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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