BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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

    Temporary Titanium Abutments

    FDA Enforcement
    Class II ·Ongoing·DDS Lab·February 12, 2025

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

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

    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable

    FDA Enforcement
    Class II ·Ongoing·C-RAD POSITIONING AB·January 21, 2026

    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

    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

    FDA Enforcement
    Class II ·Ongoing·C-RAD POSITIONING AB·June 4, 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

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

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

    BD Kiestra" ReadA; Catalog No.: 446948.

    FDA Enforcement
    Class II ·Ongoing·BD KIESTRA LAB AUTOMATION·April 8, 2026

    The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The product comes in two configurations: UV-C x 1; UV-A x 4, or UV-C x 2; UV-A x 3. The product has two peak emission wavelengths at 274 nm and 397 nm.

    FDA Enforcement
    Class II ·Ongoing·Uvlizer c/o RAIS INTERNATIONAL LLC·April 29, 2026

    The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a peak emission wavelength at 254 nm.

    FDA Enforcement
    Class II ·Ongoing·Uvlizer c/o RAIS INTERNATIONAL LLC·April 29, 2026