BEUDAMED
    47 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·August 31, 2022

    Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025

    Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·January 15, 2025

    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

    FDA Enforcement
    Class II ·Ongoing·Breas Medical, Inc.·July 20, 2022

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

    FDA Enforcement
    Class II ·Ongoing·LINK BIO CORP·July 31, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories·April 3, 2024

    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 Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·September 10, 2025

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Enforcement
    Class II ·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    CMV IgM EIA, in vitro diagnostic.

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc·July 10, 2019

    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 Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·September 30, 2020

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

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·June 8, 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 Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·November 24, 2021

    BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·March 23, 2022

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·May 25, 2022

    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 Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·November 24, 2021

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

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·May 17, 2023

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

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·April 19, 2023