BEUDAMED
    17 results · 32ms · Sources: EU EUDAMED, US FDA

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    HEPARIN ASSAY CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·03596010032102·TRIANGULAR NUT FOR SMALL BONE FIXATOR

    FILAC FAS TEMP ELECTRONIC THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDROFIX SURGICAL SHEET

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 18, 2021

    ZIMMER

    FDA Adverse Event
    Injury ·*·Product code LXH·August 15, 2006

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 9, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 19, 2014

    MAYFIELD ULTRA BASE UNIT

    FDA Adverse Event
    Malfunction ·INTEGRA, CINCINNATI·Product code HBL·May 17, 2011

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 23, 2019

    UNKNOWN PROGRIP MESH PRODUCT

    FDA Adverse Event
    Malfunction ·SOFRADIM PRODUCTION SAS·Product code FTL·October 18, 2023

    UNKNOWN ABSORBATACK

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 19, 2023

    FORCETRIAD

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·October 25, 2023

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GAM·October 19, 2023

    Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)

    FDA Enforcement
    Class II ·Ongoing·TERRAGENE S.A.·February 7, 2024

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

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