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

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    TRI-MED QUICK-STEP GASTRIC LAVAGE KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALPHA ORTHOPAEDICS AT2 SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMPELLA 5.5

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·October 4, 2025

    BIVONA CUSTOMIZED HYPERFLEX TRACHEOSTOMY TUBES

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.,·Product code JOH·December 6, 2010

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013

    ACCENT DR RF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    EU ENT4.5MMD 14MML WNO DSTL TP

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code NJE·June 15, 2022

    EU 4.5X14MM STENT 12 MM DW TIP

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·June 15, 2022

    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