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

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    DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer

    FDA Recall
    Open, Classified ·DERMASENSOR INC·Product code QZS·October 13, 2025

    QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3

    FDA Recall
    Open, Classified ·Microgenics Corporation·Product code MLM·January 20, 2022

    QMS Tacrolimus Calibrators, Product code 10015573

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JIT·November 21, 2023

    Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·November 26, 2025

    Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·November 26, 2025

    Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.

    FDA Recall
    Open, Classified ·The Binding Site Group, Ltd.·Product code OTA·April 16, 2026

    ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code FZS·December 3, 2024

    iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

    FDA Recall
    Open, Classified ·AMO Manufacturing USA, LLC·Product code LZS·October 21, 2021