BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·August 16, 2023

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 26, 2025

    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·December 31, 2025