BEUDAMED
    43 results · 52ms · Sources: EU EUDAMED, US FDA

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    Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

    FDA Recall
    Open, Classified ·Stradis Healthcare·Product code OWL·December 15, 2022

    Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.

    FDA Recall
    Open, Classified ·Stradis Healthcare·Product code LRS·December 15, 2022

    Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

    FDA Recall
    Open, Classified ·Stradis Healthcare·Product code LRS·December 15, 2022

    Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

    FDA Recall
    Open, Classified ·Stradis Healthcare·Product code LRS·December 15, 2022

    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 18, 2023

    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.

    FDA Recall
    Open, Classified ·Accelerated Care Plus Corporation·Product code ITX·August 25, 2021

    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.

    FDA Recall
    Open, Classified ·Aesthetics Systems Usa Inc·Product code ITX·August 23, 2021

    PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.

    FDA Recall
    Open, Classified ·Stradis Healthcare·Product code PKD·December 15, 2022

    EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ITX·August 27, 2021

    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:

    FDA Recall
    Open, Classified ·DJO, LLC·Product code ITX·September 7, 2021

    Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coast Ultrasound Gel, 5 liters (4); NC70479C/Norco Ultrasound Gel, 250 mL (24); NC70479C/North Coast Ultrasound Gel, 250 mL (24)

    FDA Recall
    Open, Classified ·North Coast Medical Inc·Product code ITX·August 27, 2021

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile

    FDA Recall
    Open, Classified ·Biosense Webster, Inc.·Product code DYB·February 21, 2023

    Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile

    FDA Recall
    Open, Classified ·Biosense Webster, Inc.·Product code DYB·February 21, 2023

    VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

    FDA Recall
    Open, Classified ·Accriva Diagnostics, Inc.·Product code JOZ·October 21, 2025

    Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code EOQ·October 18, 2023

    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code EOQ·October 18, 2023

    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code EOQ·October 18, 2023

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.

    FDA Recall
    Open, Classified ·Carestream Health, Inc.·Product code IZL·October 2, 2023

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025