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    AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 13, 2010

    CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535)

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·May 9, 2014

    InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF DBM002. InterGro DBM product contain human tissue (allograft bpm) and are intended for transplantation. Products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure.

    FDA Recall
    Terminated ·Michigan Orthopaedic Products, Inc.·Product code MQV·May 5, 2008

    FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The FLAIR Endovascular Stent Graft is available in both flared and straight configurations. The distal end of the flared configuration devices are approximately 4mm larger in diameter than the body section.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MIH·October 19, 2015

    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood

    FDA Recall
    Terminated ·BBI SOLUTIONS OEM LTD 8 Tom McDonald Avenue Dundee United Kingdom·Product code GHH·June 1, 2016

    Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code DSY·January 5, 2016

    Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code DSY·January 5, 2016

    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019

    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code MSD·May 31, 2019