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

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFS·November 6, 2014

    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

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

    Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFS·November 13, 2014

    Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    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

    Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·August 24, 2004

    Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software

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

    Digital Radiography System Model DFP8000D

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

    High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system.

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code JAA·September 21, 2005

    Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code IYN·May 23, 2005