BEUDAMED
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    NUCLISENS Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

    FDA Recall
    Terminated ·BIOMERIEUX Grenoble Biomerieux Institut Christophe Merieux; 5 Rue Des Berges; Cs·Product code PPM·January 10, 2020

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    FDA Recall
    Terminated ·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013

    NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.

    FDA Enforcement
    Class II ·Terminated·BIOMERIEUX - Grenoble·March 4, 2020

    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.

    FDA Recall
    Terminated ·Mortara Instrument, Inc·Product code DPS·May 29, 2015

    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.

    FDA Enforcement
    Class II ·Terminated·Mortara Instrument, Inc·June 24, 2015

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code LYS·October 20, 2006

    Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    StemPro MSC SFM CTS"

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NDS·June 11, 2019

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

    X-ray, Computed Tomography, Model TSX101A

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAK·January 14, 2003

    Digital Radiography System Model DFP-8000D/FPD,

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAA·November 10, 2005

    Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·January 27, 2004

    Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code IYN·October 2, 2007

    NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshiba America Medical Systems, Inc., Tustin, CA.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code IYO·August 29, 2007

    Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAK·October 1, 2007