BEUDAMED
    49 results · 13ms · Sources: EU EUDAMED, US FDA

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    C9-3io Transducer Probe

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code IYN·July 3, 2025

    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.

    FDA Recall
    Open, Classified ·Product code QRX·September 11, 2025

    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

    FDA Recall
    Open, Classified ·Product code QRX·May 23, 2025

    Alcohol (ALC) Test Saliva

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DIC·November 3, 2025

    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories·Product code OYX·February 15, 2024

    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00

    FDA Recall
    Open, Classified ·LINK BIO CORP·Product code HWT·June 27, 2024

    BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code MID·February 28, 2023

    Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LGD·May 30, 2025

    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022

    BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·February 8, 2022

    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code NHX·February 21, 2023

    EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc·Product code JJE·January 10, 2019

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·April 14, 2022

    BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·April 21, 2020

    BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code NHX·February 21, 2023

    BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·September 17, 2021

    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·February 8, 2022

    CMV IgM EIA, in vitro diagnostic.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LFZ·October 19, 2022

    BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LIP·September 17, 2021

    Skytron Ergon 3 Series Skyboom Monitor Bracket-Flatscreen Bracket, single monitor mount, 27" max. screen size Part number 3FCM1

    FDA Recall
    Open, Classified ·Skytron, Div. The KMW Group, Inc·Product code FQO·March 5, 2020