BEUDAMED
    29 results · 10ms · Sources: EU EUDAMED, US FDA

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    AcoSound. Model Number: LW12-BTE-M

    FDA Recall
    Open, Classified ·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.·Product code QUG·April 25, 2025

    Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

    FDA Recall
    Open, Classified ·Oxoid Limited Wade Road Basingstoke United Kingdom·Product code JTN·December 23, 2024

    BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Cefixime - 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231664

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231672

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657and 231658

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231705 and 231706

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    BD BBL Sensi Disc Cefotaxime - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231606 and 231607; 5 ug, Catalog No. 291308

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JTN·January 8, 2024

    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·March 5, 2024

    MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).

    FDA Recall
    Open, Classified ·Biomerieux Inc·Product code OUG·February 6, 2023

    Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·October 6, 2025

    t:slim X2 Insulin Pump with Interoperable Technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·February 27, 2025

    t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·July 3, 2025

    Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

    FDA Recall
    Open, Classified ·Product code QFG·November 30, 2023

    MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code QFG·January 30, 2026

    The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.

    FDA Recall
    Open, Classified ·Opternative Inc·Product code OUG·May 20, 2019

    Omnipod 5 Automated Insulin Delivery System

    FDA Recall
    Open, Classified ·Product code QFG·February 28, 2023

    Tandem Mobi Insulin Pump with Interoperable Technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·February 27, 2025

    iLet Bionic Pancreas, REF: BB1001

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·September 23, 2025