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

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    DIOnavi-Denture

    FDA 510(k)
    FDA Class 2 ·Dental

    GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEWDEAL INTERPHALANGEAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·January 12, 2018

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 14, 2011

    NERVE HOOK CUSHION BULL TIP

    FDA Adverse Event
    Malfunction ·SPECIALTY SURGICAL INSTRUMENTATION·Product code GDG·October 8, 2008

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 25, 2013

    LASSOSTARNAV,10P,15MM DIA LOOP

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

    LASSOSTAR CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022

    BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

    FDA Enforcement
    Class II ·Ongoing·Civco Medical Instruments Co. Inc.·June 11, 2025