BEUDAMED
    16 results · 34ms · Sources: EU EUDAMED, US FDA

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    DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131262264·H100, RITE 312 WL CBE HHM

    BRAEMAR MANUFACTURING, LLC

    FDA registration
    BRAEMAR MANUFACTURING, LLC·4 products·🇺🇸 United States

    ER920W WIRELESS EVENT RECORDER

    FDA Adverse Event
    Malfunction ·BRAEMAR MANUFACTURING LLC·Product code MLO·May 10, 2018

    ALLERGEAZE R CLEAR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AMERSHAM HEALTH NEEDLE-GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNIT,C6S 3.0,BTH

    FDA Adverse Event
    Malfunction ·BRAEMAR MANUFACTURING, LLC·Product code DSI·July 6, 2023

    C6 MCOT PPM

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·September 11, 2023

    C6 MCOT PPM

    FDA Adverse Event
    Malfunction ·BRAEMAR MANUFACTURING, LLC·Product code DSI·November 16, 2023

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·May 29, 2013

    6.5X90MM CANN CANC SCR 22

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. 'R.L.·Product code HWC·June 13, 2011

    COBAS INTEGRA 800

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

    UNIVERSAL ELECTRODE-PATCH

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·August 23, 2024

    C6 MCOT PPM

    FDA Adverse Event
    Injury ·BRAEMAR MANUFACTURING, LLC·Product code DSI·November 16, 2023

    ER920W EVENT RECORDER

    FDA Adverse Event
    Malfunction ·BRAEMAR MANUFACTURING LLC·Product code DRG·February 6, 2018

    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