BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Alice NightOne

    FDA UDI
    Respironics, Inc.·00606959047341·Alice NightOne System, Wireless, Nonin, North A...

    MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CHINA NAILS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

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

    PARADIGM INSULIN INFUSION PUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 29, 2013

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 20, 2011

    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