BEUDAMED
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    Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·April 29, 2020

    Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 31, 2021

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024