BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    BRYAN SPINAL FIXATER (BSF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867057753·UNI GLENOID-PERIPHERAL LOCK SCRW

    FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACRYL-X SYSTEM TM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNI GLENOID-PERIPHERAL LOCK SCRW

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code PHX·January 3, 2023

    UNI GLENOID-PERIPHERAL LOCK SCRW

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code PHX·October 20, 2023

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 14, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 3, 2010

    ATLAS PLUS DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 3, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015