BEUDAMED
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    THE HEART LASER CO2 TMR SYSTEM

    FDA Adverse Event
    Malfunction ·PLC MEDICAL SYSTEMS, INC.·Product code MNO·April 2, 1999

    THE HEART LASER CO2 TMR SYSTEM

    FDA Adverse Event
    Death ·PLC MEDICAL SYSTEMS, INC.·Product code MNO·March 5, 1999

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·February 28, 2018

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·July 13, 2023

    Deltec Cozmo 3 ml Insulin Cartridge with 0.7mm(22G) x 12.5mm (1/2 in.) needle and cap. Reorder No. 21-1750-24. Immediate container states STERILE EO, Rx Only , Deltec, Inc., St. Paul, MN 55112. Additional labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged. do not use if package is opened or damaged, or if product appears damaged. Made in Mexico for: Deltec 1265 Grey Fox Road, St. Paul, MN 55112 USA, Smiths, smiths Medical - a part of Smiths Group plc.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·October 15, 2004

    PROTHIA

    Importer
    🇫🇷 France·4 Manufacturers

    Medica, medicinska zastopstva, trgovina, marketing in posredovanje, d.o.o.

    Importer
    🇸🇮 Slovenia·6 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    Vingmed AB

    Importer
    🇸🇪 Sweden·25 Manufacturers

    Shanghai International Holding Corp. GmbH(Europe)

    Authorized representative
    🇩🇪 Germany·637 Manufacturers·33064 Devices

    Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ionexchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LCP·December 1, 2009

    Surgical lighting systems iLED and TruLight in use with the ALC+ function. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

    FDA Recall
    Terminated ·Trumpf Medical Systems, Inc.·Product code FSY·January 9, 2012

    Qualrep Services B.V.

    Authorized representative
    🇳🇱 Netherlands·24 Manufacturers·43 Devices

    ICON (LR) Limited

    Authorized representative
    🇮🇪 Ireland·37 Manufacturers·384 Devices

    GE Medical Systems SCS

    Authorized representative
    🇫🇷 France·27 Manufacturers·564 Devices

    Philips Medical Systems Nederland B.V.

    Authorized representative
    🇳🇱 Netherlands·21 Manufacturers·1029 Devices

    MPS Medical Product Service GmbH

    Authorized representative
    🇩🇪 Germany·35 Manufacturers·1959 Devices

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    MedPass SAS

    Authorized representative
    🇫🇷 France·13 Manufacturers·130 Devices