BEUDAMED
    72 results · 11ms · Sources: EU EUDAMED, US FDA

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    ***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

    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

    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

    Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GAC·December 29, 2011

    PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    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

    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    FDA Recall
    Terminated ·DePuy Spine, Inc.·Product code GCC·July 31, 2013

    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