BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    The 5000 Compact Series Ultrasound Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101247·WILLS EYE SPUD AND BURR

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810162·Femoral Head, 28mm, -3.5mm, Ceramic

    LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems

    FDA Recall
    Terminated ·Accuray Incorporated·Product code IYE·August 31, 2018

    TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

    FDA Recall
    Terminated ·TomoTherapy Incorporated·Product code MUJ·June 23, 2010

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025