BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    EXPRESSO CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SwishPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307106111·3.3mmD x 16mmL, 3.7mmD Platform

    PGE Wilderness Tactical Backpack

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588233161·PGE Wilderness Tactical Backpack

    HEINE OMEGA 500

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·January 5, 2026

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013

    SIMON NITINOL FILTER SYSTEM

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 29, 2010

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015