BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Digital Flat Panel Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Sbo Hearing A/S·05714464021574·CORAL 3 FW 4.1

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795129062·BALL JOINT STRUT, XX-SMALL

    SPACELABS HEALTHCARE

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122644·PATIENT CABLE SINGLE CHANNEL, BLK/WHT, US CODE

    Spacelabs Healthcare

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126048·PATIENT CABLE SINGLE CHANNEL, BLK/WHT, US CODE

    PORTABLE RO+ MODEL MROS09

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 16, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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