BEUDAMED
    741 results · 71ms · Sources: EU EUDAMED, US FDA

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    ABBOTT LABORATORIES, INC.

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES, INC.·Product code DQX·February 25, 2005

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·August 7, 2019

    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular·January 9, 2013

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·August 7, 2019

    Abbott Diagnostics GmbH

    Importer
    🇩🇪 Germany·6 Manufacturers

    Abbott GmbH

    Authorized representative
    🇩🇪 Germany·4 Manufacturers

    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JQP·October 27, 2008

    Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular·July 25, 2012

    CLINICAL CHEMISTRY CARBON DIOXIDE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code KHS·July 9, 2018

    RX ACCUNET

    FDA Adverse Event
    ABBOTT LABORATORIES, INC·Product code NTE·March 7, 2012

    PLUM XL

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES, INC.·Product code FRN·March 11, 2002

    PLUM A+

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES, INC.·Product code FRN·March 11, 2002

    ABBOTT

    FDA Adverse Event
    Injury ·ABBOTT LABORATORIES INC·Product code FRN·November 4, 2003

    ABBOTT AXSYM SYSTEM

    FDA Adverse Event
    Other ·ABBOTT LABORATORIES, INC.·Product code JJE·September 7, 2000

    IMX ANALYZER

    FDA Adverse Event
    Other ·ABBOTT LABORATORIES, INC.·Product code LCI·June 26, 2000

    ABBOTT LABORATORIES

    FDA Adverse Event
    Injury ·ABBOTT LABORATORIES, INC.·Product code MGB·June 27, 2000

    LIFECARE PLUM PUMP MODEL 5000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES, INC.·Product code FRN·May 26, 2000

    ABBOTT AXSYM SYSTEM

    FDA Adverse Event
    Other ·ABBOTT LABORATORIES, INC.·Product code JJE·June 30, 2000

    LIFECARE PCA PLUS INFUSER

    FDA Adverse Event
    Other ·ABBOTT LABORATORIES, INC.·Product code MEA·May 26, 2000

    ABBOTT AXSYM SYSTEM

    FDA Adverse Event
    Other ·ABBOTT LABORATORIES, INC.·Product code JJE·May 31, 2000