BEUDAMED
    2 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 10, 2025

    Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·March 23, 2022