BEUDAMED
    7 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    IntelliVue G7m Anesthesia Gas Module, Product Number 866173

    FDA Enforcement
    Class II ·Ongoing·Philips North America·October 9, 2024

    EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Phadia Ab·January 31, 2024

    BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for semi-quantitative in vitro susceptibility testing by the agar disc diffusion test procedure of common, rapidly growing and certain fastidious bacterial pathogens. Catalog Number: 231263

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·December 11, 2024

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·July 29, 2020

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    FDA Enforcement
    Class II ·Terminated·Dukal Corp.·December 20, 2017

    Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.

    FDA Enforcement
    Class II ·Terminated·Phadia Ab·April 11, 2018