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

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    AcoSound. Model Number: LW12-BTE-M

    FDA Recall
    Open, Classified ·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.·Product code QUG·April 25, 2025

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code QMN·January 3, 2024

    IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    Lazervida 10W diode laser cutter and engraver with Lazervida shield.

    FDA Recall
    Open, Classified ·Flux Technology Inc.·Product code RHK·February 19, 2025

    NOxBOXi Nitric Oxide Delivery System

    FDA Recall
    Open, Classified ·NOXBOX LTD·Product code MRN·July 19, 2023

    IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MWI·September 6, 2022

    The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code OEA·June 3, 2024

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Recall
    Open, Classified ·IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)·Product code ONG·October 16, 2024

    The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·February 4, 2026

    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OHD·April 15, 2021

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OUO·June 14, 2024

    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024

    SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code LNH·June 14, 2024