BEUDAMED
    22 results · 26ms · Sources: EU EUDAMED, US FDA

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    Assure Titanium Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055735·METZENBAUM SCISSORS STRAIGHT BLADES POWER CUT B...

    ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JJE·September 11, 2009

    ARCHITECT SYSTEM SOFTWARE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·September 25, 2009

    WILSON-COOK ZILVER BILIARY STENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    APEX MODULAR HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

    ZILVER BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·July 29, 2011

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·July 1, 2013

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2020