BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814183·GENUMEDI PT SILVER L I

    THERMAL MASSAGE BED, MODEL 2D-GX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD MAX¿ VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·December 17, 2025

    BD MAX¿ VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·February 3, 2026

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011

    SUPPORT ARM 176

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code IOY·May 21, 2013

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020