BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NON-CONTACT INFRARED THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCHITECT IVANCOMYCIN

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LEH·May 20, 2026

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 1, 2014

    2520274-2013-02887

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KTW·May 29, 2013

    GYNECOLOGY DISPOSABL

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE·Product code HIH·June 17, 2011

    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