BEUDAMED
    215 results · 18ms · Sources: EU EUDAMED, US FDA

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    CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    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

    Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ITX·October 16, 2020

    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

    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008

    ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816, 10563788; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc., Mountain View, CA 1230 Shorebird Way P.O. Box 7393 Mountain View CA 94043·Product code ITX·August 17, 2010

    CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.

    FDA Recall
    Terminated ·Verathon, Inc.·Product code ITX·September 29, 2020

    Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17

    FDA Recall
    Terminated ·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021

    Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N

    FDA Recall
    Terminated ·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021

    Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N

    FDA Recall
    Terminated ·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 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

    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code ITX·October 14, 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