BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POLYSTAT, BIOLOGICAL STAIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    HMP DUAL POLYSULFONE PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COBAS C 503 ANALYTICAL UNIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 11, 2026

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·February 5, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 18, 2014

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 3, 2011

    Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021