BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    SnapshotNIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Synthes GmbH·10886982143358·1.8MM BUTTRESS PIN/26MM

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112397·BARD-PARKER HANDLE #9

    STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

    FDA 510(k)
    FDA Class 2 ·Hematology

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

    SPEEDSTITCH SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GAT·June 27, 2013

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 5, 2011

    ZENITH FENESTRATED GRAFT

    FDA Adverse Event
    Death ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MIH·November 20, 2023

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·March 29, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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