BEUDAMED
    21 results · 31ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Mini-Mono® Brackets

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70602431·Mini-Mono-Brackets Andrews 'N' .022" 1000 Brackets

    TRI-FIT FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LASERPRO 16

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD ULTRASAFE X100L PR CLEAR SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·July 26, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·September 26, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·August 21, 2019

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·April 24, 2019

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·October 3, 2019

    SYNCHROMED II IMPLANTABLE PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LKK·April 9, 2013

    MATRIX2 360 DEGREES SOFT SR COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code HCG·June 11, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 15, 2011

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·August 23, 2019

    EDWARDS LOCKING SYRINGE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code MAV·June 16, 2023

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·March 28, 2019

    ULTRASAFE X100L PR GREY SSL SDZ

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code MEG·September 11, 2019

    EDWARDS LOCKING SYRINGE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES LLC·Product code MAV·March 29, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022