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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 Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·May 28, 2014

    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

    Capnostream20 M NICU (CPM), CS08654RN

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    Capnostream20 M ADULT ICU (CPM), CS08654RA

    FDA Enforcement
    Class II ·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 6, 2016

    Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc·October 3, 2018

    Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc·October 3, 2018

    Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc·October 3, 2018

    ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 16, 2018

    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 Enforcement
    Class II ·Terminated·BBI SOLUTIONS OEM LTD·November 2, 2016

    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 7, 2021

    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

    FDA Enforcement
    Class II ·Terminated·Alcon Research, Ltd.·July 8, 2015

    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