BEUDAMED
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    S2 System, Locking Screw Fully Threaded

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWC·October 4, 2005

    T2 System, Condyle Screw

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWC·October 4, 2005

    S2 System, Condyle Screw

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWC·October 4, 2005

    S2 System, Locking Screw Partially Threaded

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWC·October 4, 2005

    Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HWC·October 4, 2005

    Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-0-KTI.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

    Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-C-KTI.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

    Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 65 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

    Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI-BNS.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·June 10, 2004

    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    FDA Enforcement
    Class II ·Terminated·Organ Recovery Systems, Inc.·March 11, 2020

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 19, 2013

    MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.

    FDA Recall
    Terminated ·Medrad Inc·Product code DXT·May 17, 2010

    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired

    FDA Recall
    Terminated ·KT Health, LLC·Product code IME·September 16, 2019

    Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Recall
    Terminated ·Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany·Product code GEX·October 17, 2018

    Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Recall
    Terminated ·Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany·Product code GEX·October 17, 2018

    Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Recall
    Terminated ·Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany·Product code GEX·October 17, 2018

    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Recall
    Terminated ·Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany·Product code GEX·October 17, 2018

    Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Recall
    Terminated ·Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany·Product code GEX·October 17, 2018

    Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Enforcement
    Class II ·Terminated·Leoni Fiber Optics GmbH·December 19, 2018

    Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    FDA Enforcement
    Class II ·Terminated·Leoni Fiber Optics GmbH·December 19, 2018