BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    NeoGen PSR System

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

    Oticon

    FDA UDI
    Oticon A/S·05714464007240·OTICON MORE 1 MINIRITE R C063

    Sparrow Therapy System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AVINENT DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GATEWAY PTA BALLOON

    FDA Adverse Event
    Injury ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code GBA·November 4, 2008

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 17, 2011

    INFINITY SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·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