BEUDAMED
    4 results · 8ms · Sources: EU EUDAMED, US FDA

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

    Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries Inc·April 21, 2021

    STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.

    FDA Enforcement
    Class II ·Ongoing·Stanbio Laboratory, LP·December 13, 2023

    Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

    FDA Enforcement
    Class II ·Ongoing·IHB OPERATIONS B.V.·April 30, 2025

    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

    FDA Enforcement
    Class II ·Ongoing·IHB OPERATIONS B.V.·December 13, 2023