BEUDAMED
    31 results · 11ms · Sources: EU EUDAMED, US FDA

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    23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NGY·August 11, 2015

    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan·Product code NGY·October 27, 2020

    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak, Constellation 23G Combined Pack (0.9 mm and 1.1 mm) and 23G Small Parts Kit. Single use 23G non-valved trocar cannulas are used to provide internal access to the ocular cavity during ophthalmic surgery. Single use infusion cannulas are used for the infusion of fluid or air during ophthalmic surgery to maintain intraocular pressure during posterior segment surgeries.

    FDA Recall
    Terminated ·Alcon Research, LTD. 9965 Buffalo Speedway·Product code NGY·May 29, 2012

    19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32; Manufactured by Alcon Grieshaber, Ltd., Schaffhauxen, Switzerland CH8203.

    FDA Recall
    Terminated ·Alcon Research, Ltd·Product code NGY·January 18, 2007

    Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NGY·August 11, 2015

    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan·Product code NGY·October 27, 2020

    Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code NGY·April 29, 2009

    Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code NGY·April 29, 2009

    Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code NGY·August 11, 2015

    Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan·Product code NGY·February 20, 2023

    Multitom RAX with software version VF10

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 9, 2021

    AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

    FDA Recall
    Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

    AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

    FDA Recall
    Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    FDA Recall
    Terminated ·VGI Medical, LLC·Product code OVD·April 9, 2018

    Multitom RAX with software version VF10

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021

    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)

    FDA Enforcement
    Class II ·Terminated·Western / Scott Fetzer Company·July 2, 2014

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    FDA Recall
    Terminated ·RGI Medical Manufacturing, Inc.·Product code FPA·March 28, 2014

    VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit

    FDA Enforcement
    Class II ·Terminated·VGI Medical, LLC·June 13, 2018

    Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    FDA Recall
    Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

    Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    FDA Recall
    Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009