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

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

    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    API JAMES 2AMP, CATALOG 70542

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API NIT1 NIT2 REAGENTS, CATALOG 70442

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API VP1 VP2 REAGENTS, CATALOG 70422

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API 20 E 25 STRIPS, CATALOG 20100

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·January 11, 2023

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023