BEUDAMED
    128 results · 23ms · Sources: EU EUDAMED, US FDA

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    IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEC·November 11, 2010

    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.

    FDA Recall
    Terminated ·Qualigen Inc·Product code CEC·November 8, 2013

    Dimension Free Thyroxine (FT4L) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEC·January 2, 2018

    Alinity i Free T4 Reagent Kit, List Number 07P7030

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CEC·November 21, 2018

    Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CEC·March 5, 2018

    Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    Access Immunoassay Systems Free T4, Part Number: 33880

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEC·March 24, 2010

    The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEC·April 12, 2010

    Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEC·April 30, 2019

    Access System-Free T4 Assay, B01902E, Catalog No. 33880

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEC·May 9, 2017

    ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CEC--·December 15, 2003

    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011

    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code GCT·May 20, 2011

    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012

    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·October 3, 2012

    Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)

    FDA Recall
    Terminated ·Natus Medical Inc·Product code ETY·June 27, 2005

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Recall
    Terminated ·Ceg Enterprises Llc·Product code MCF·April 5, 2016

    GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015