BEUDAMED
    81 results · 23ms · Sources: EU EUDAMED, US FDA

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    Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN

    FDA Recall
    Open, Classified ·Hologic Inc·Product code KGI·June 13, 2024

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Recall
    Terminated ·Cook Inc.·Product code KGY·May 14, 2015

    Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·April 7, 2009

    Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·April 7, 2009

    DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.

    FDA Recall
    Terminated ·Ge Healthcare·Product code KGI·February 1, 2009

    DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.

    FDA Recall
    Terminated ·Ge Healthcare·Product code KGI·February 1, 2009

    Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·September 24, 2008

    Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008

    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

    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

    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

    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

    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

    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

    PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    FDA Recall
    Terminated ·KCI USA, INC.·Product code OMP·January 30, 2014