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    PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code KOG·November 17, 2014

    OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer

    FDA Recall
    Terminated ·Innovatech Medical Resources L.P.·Product code KOG·August 8, 2011

    ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

    FDA Recall
    Terminated ·ConforMIS, Inc.·Product code OOG·August 31, 2015

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PNG·April 22, 2023

    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr

    FDA Recall
    Terminated ·Pdg Product Design Group Inc 9165 Shaughnessy St Vancouver Canada British Columbia·Product code IOR·June 12, 2012

    RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·July 13, 2015

    Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

    FDA Recall
    Terminated ·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code IZL·January 18, 2016

    MobileDiagnost wDR motorized portable diagnostic X-ray systems.

    FDA Recall
    Terminated ·Sedecal S.A. C/Pelaya, 9-13 Pol. Industrial Rio De Janiero Algete Spain·Product code IZL·August 6, 2014

    Sedecal NOVA FA DR System. for diagnostic radiography.

    FDA Recall
    Open, Classified ·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code MQB·July 18, 2018

    CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.

    FDA Recall
    Terminated ·Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt·Product code KGX·February 21, 2011