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

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    uCT ATLAS Astound with uWS-CT-Dual Energy Analysis

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034001869·ISOLA SPINE SYSTEM ASSEMBLY WITH CENTER NUT 4.75mm

    VariAx

    FDA UDI
    Stryker GmbH·37613153067888·BONE SCREWS, CROSS-PIN

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A223028150·22mm H x 30mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A223028120·22mm H x 30mm W x 28mm L x 12 degrees ALIF

    VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH

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

    DEMETECH NYLON NONABSORBABLE SUTURE

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

    CADD DUODOPA CASSETTE

    FDA Adverse Event
    Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·November 21, 2025

    SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·November 4, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 12, 2013

    ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code FPA·June 26, 2024

    ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024