BEUDAMED
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    Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·January 10, 2007

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·January 10, 2007

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Enforcement
    Class II ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Enforcement
    Class III ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022