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

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    DuraPro™ Oscillating System

    FDA 510(k)
    FDA Class 2 ·Neurology

    POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 10, 2014

    PS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·September 9, 2011

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code GEI·July 16, 2013

    BD DISCARDIT¿ II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 4, 2019

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021