BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    PT DISTAL TIP CEMENT SPACER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRI-COUNT CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    DART CK-MB REAGENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·July 2, 2015

    TORQUE LIMITING ATTACHMENT 1.2NM

    FDA Adverse Event
    Injury ·DEPUY SYNTHES POWER TOOLS·Product code LXH·June 25, 2014

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 3, 2013

    Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 14, 2013