BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PEN NDL 31GA 5MM 100BX 1200 USA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 8, 2020

    PROFUSION BONE VOID FILLER KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CENTRIFUGAL PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code DZL·April 16, 2013

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 4, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 4, 2011

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015