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

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    DISCOSCOPES, CERVICAL ENDOSCOPES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEFORTE NEURO SYSTEM BONE PLATE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDTRONIC MINIMED 670G

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code CGA·December 6, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 24, 2013

    FORTIFY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·September 30, 2014

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

    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