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

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    ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010064936·4.0MM PARTIALLY THREADED ...

    ACIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADMIRA SEAL

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGN·May 20, 2011

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 21, 2013

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·September 26, 2014

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·December 10, 2025

    XIA TITANIUM 4.5 BLOCKER

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

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015