BEUDAMED
    207 results · 15ms · Sources: EU EUDAMED, US FDA

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    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Recall
    Completed ·Philips Healthcare Informatics, Inc.·Product code LLZ·April 19, 2019

    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

    FDA Enforcement
    Class II ·Completed·Philips Healthcare Informatics, Inc.·June 17, 2020

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Recall
    Completed ·GE Healthcare, LLC·Product code KPS·May 24, 2018

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, when used on the Android 13 Operating System

    FDA Enforcement
    Class II ·Completed·Abbott Diabetes Care, Inc.·January 24, 2024

    Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

    FDA Enforcement
    Class II ·Completed·Fresenius Medical Care Holdings, Inc.·November 18, 2020

    Discovery NM/CT 670 Pro, model 5376204-70-54

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Discovery NM/CT 670 ES, model 5376204-70-57

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150

    FDA Enforcement
    Class I ·Completed·ResMed Ltd.·February 12, 2020

    TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

    FDA Enforcement
    Class III ·Completed·STRATASYS LTD·July 16, 2025

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    FDA Enforcement
    Class II ·Completed·Murata Vios, Inc.·January 22, 2025

    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Completed·ICU Medical, Inc.·October 10, 2018

    VariCam

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·January 16, 2019

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Enforcement
    Class II ·Completed·Withings Sas·August 22, 2018

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Enforcement
    Class II ·Completed·SynCardia Systems LLC·November 1, 2023

    SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

    FDA Enforcement
    Class II ·Completed·C.R. Bard, Inc.·April 26, 2017