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

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    CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURESHOT Distal Targeting System V4.0 Trauma Interface

    FDA 510(k)
    FDA Class 2 ·Neurology

    RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

    SPL LEAD, TRANSVENOUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 15, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 24, 2011

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023