BEUDAMED
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    PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HTW·February 22, 2008

    PERPOS Driver; Catalog # 6112 Interventional Spine, Inc. A cannulated, driver to be used over a K-wire to engage the head of the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) and drive it into the bone. The PERPOS Driver (61 12) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02), a component of the Reusable BONE-LOK PLS System (9039-01, 9039-02), or as a stand-alone tool.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code HXX·February 3, 2011

    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01

    FDA Recall
    Terminated ·Phadia US Inc·Product code LSW·December 14, 2020

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·December 18, 2013

    Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·June 5, 2019

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Enforcement
    Class II ·Terminated·Lsi Medience Corporation·November 30, 2016

    Pathfast D-Dimer, Reference number: PF1051-KUS

    FDA Recall
    Terminated ·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016

    RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use

    FDA Recall
    Terminated ·Ability Dynamics LLC·Product code ISW·June 2, 2014

    Polyflex Esophageal Stent 20/16mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Polyflex Esophageal Stent 20/16mm x 120mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·July 15, 2010

    Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010

    Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog Number M00513810. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010

    Polyflex Esophageal Stent 25/21mm x 150mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger

    FDA Recall
    Terminated ·iwalk inc·Product code ISW·October 26, 2012

    Polyflex Esophageal Stent 25/21mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Polyflex Esophageal Stent 23/18mm x 90mm

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·April 16, 2003

    Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/15. Catalog Number M00513830. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010

    Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code ESW·May 17, 2010