BEUDAMED
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    TISSUE-TEK III MINI-RAPID PROCESSOR

    FDA 510(k)
    FDA Class 1 ·Pathology

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750001200·VITROS Immunodiagnostic Products Anti-HBc IgM C...

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118009·Rhein Tubular 23g Caps. Forceps

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209129270·

    MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BROWNE OPA TEST STRIP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

    2520274-2012-02445

    FDA Adverse Event
    Injury ·Product code NKB·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007

    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·October 15, 2021

    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics, Inc.·November 24, 2021

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025