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

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    SwiftMR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 2, 2022

    Thermidas IR System (ThIR-A615)

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINOX S 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·October 29, 2014

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code DTB·July 8, 2013

    DEXTRUS 4137

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·November 9, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023