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

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    STAK-CHEX PLUS RETICS

    FDA 510(k)
    FDA Class 2 ·Hematology

    LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.24cm, without wire

    FDA UDI
    Promepla·03700512967583·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450029305·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450203880·

    ENHANCED COMPENSATING FILTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORBITER II CCI/SPECT ORBITER II CCI/SPECT

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2024

    LIGASURE IMPACT THORACIC

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·April 19, 2013

    STRATUS CS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JHX·September 15, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015