BEUDAMED
    76 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue

    FDA Recall
    Open, Classified ·Scrip Inc·Product code ITX·August 18, 2021

    EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1

    FDA Recall
    Open, Classified ·ImaCor Inc.·Product code ITX·September 16, 2024

    Philips X5-1 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips L12-4 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips L9-3 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    SCNHD LA L7-4 HDI Transducer Probe

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·July 3, 2025

    Philips Mini Multi TEE Ultrasound Transducer

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·September 5, 2025

    Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code ITX·September 25, 2023

    EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU

    FDA Recall
    Open, Classified ·Red Medical Supplies·Product code ITX·August 11, 2021

    Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

    FDA Recall
    Open, Classified ·Scrip Inc·Product code ITX·August 18, 2021

    Philips XL14-3 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips S8-3t Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips C5-1 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips OMNI III TEE Ultrasound Transducer

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·September 5, 2025

    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

    Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Philips L12-3 Transducer.

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·May 28, 2025

    Philips OMNI II TEE Ultrasound Transducer

    FDA Recall
    Open, Classified ·Philips Ultrasound, Inc·Product code ITX·September 5, 2025