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

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    Pulse Oximeter ( PO2, PO2A, PO2B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·14026704920706·

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704266627·FRAZIER SUCTION TUBES 7.5" ANGLED 11 FRENCH

    URS LP DIGITAL, MILLENNIUM, RADPRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 2, 2025

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·November 19, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 23, 2013

    CERTAS PLUS INLINE WITH SIPHON

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·March 24, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025