BEUDAMED
    29 results · 17ms · Sources: EU EUDAMED, US FDA

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    XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product List Number-9506-01

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LGI·May 31, 2007

    XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number 9506-10

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LGI·May 31, 2007

    AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine prepared in human serum to yield the different concentration ranges-Product List Number 7A73-10

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LGI·May 31, 2007

    AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LGI·May 31, 2007

    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

    20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.

    FDA Recall
    Terminated ·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·Product code FPA·July 24, 2017

    ZVU Functional GI Software, REF: ZVU-3

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·July 25, 2023

    Multitom RAX with software version VF10

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

    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

    FDA Recall
    Open, Classified ·Product code PPB·January 7, 2026

    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

    FDA Recall
    Open, Classified ·Product code PPB·January 7, 2026

    Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.

    FDA Recall
    Terminated ·Churchill Medical Systems, Inc.·Product code FPA·January 21, 2013

    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

    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

    Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

    FDA Recall
    Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

    Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

    FDA Recall
    Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

    Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code ODC·May 12, 2026

    Pathfast D-Dimer, Reference number: PF1051-KUS

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