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

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    IV Administration Set

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEACE OF MIND HOME DRUG TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    EXCELSIOR XT-27 MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·January 4, 2023

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·March 11, 2026

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 22, 2008

    GOOSE NECK¿ MICRO SNARE

    FDA Adverse Event
    Injury ·EV3 INC.·Product code DXE·August 17, 2011

    PELVILACE BIOURETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FTL·July 3, 2013

    HEARTMATE®, MOBILE POWER UNIT, N/A

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 3, 2025

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 5, 2022

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019