7 results
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8ms
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Sources: EU EUDAMED, US FDA
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
FDA Enforcement
Class II
·Ongoing·Philips North America·October 9, 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
Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·June 10, 2020
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
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