BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017934·K-Wire, Double Ended, Trocar Point, Diameter Si...

    TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CALYPSO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LGD·October 21, 2014

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·October 6, 2008

    INSTINCT ENDOSCOPIC HEMOCLIP

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code MND·June 13, 2013

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017