BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    LIAISON Anti-HAV Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGXO

    FDA UDI
    Oticon A/S·05707131342669·G200, MINIRITE T 312 2.4G C090 AGXO

    K133532

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

    BD PRECISIONGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 17, 2022

    AUTOREADER 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OCELOT PIXL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD SYRINGE 10ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·February 25, 2025

    BD SYRINGE 3ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 25, 2025

    ADVIA CENTAUR XP

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·October 8, 2008

    GYNECARE TVT ABBREVO

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    MULTI-LINK 8

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·August 5, 2011

    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

    Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198

    FDA Enforcement
    Class I ·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025