BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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

    Bernafon

    FDA UDI
    Bernafon AG·05711584115350·CO5 MNR, 2.4G NFM MAC CAPTO 5 GPL

    BD SYRINGE 10ML LUER-LOK¿ TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 17, 2017

    EZSLEEP SLEEP QUALITY RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RAPIDLOK MENISCAL FASTENER

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·October 24, 2008

    PENTA LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021