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

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    Medline UNITE® REFLEX® Nitinol Staple System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K231485

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·October 25, 2025

    SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX

    FDA 510(k)
    FDA Class 2 ·Neurology

    TEXIUM

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FMF·March 19, 2026

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FRN·October 17, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2013

    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