BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE

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

    TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZURA TEE SYSTEM WITH CLARITEE PROBE

    FDA 510(k)
    FDA Class 2 ·Radiology

    VUE PACS

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025

    DUROM HIP

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 9, 2013

    TEMPO

    FDA Adverse Event
    Malfunction ·ARJO MED AB LTD·Product code FSA·April 29, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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

    ACCOLADE DR EL MRI (Model L331)

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