BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    DRYVIEW CHROMA IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213036239·Coupling Treatment Tube for 6F Flexibles (19)

    AMIS MOBILE LEG POSITIONER

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code FWX·March 6, 2014

    VITEK 2 YEAST CASPOFUNGIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 14, 2013

    ENTERRA

    FDA Adverse Event
    Injury ·MPROC, JUNCOS·Product code LNQ·August 13, 2008

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·May 13, 2011

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 29, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025