BEUDAMED
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    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209120796·

    IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

    FDA 510(k)
    FDA Class 2 ·Radiology

    cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACUMATCH M-SERIES SCREW, 23MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code LPH·June 3, 2014

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 5, 2010

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·December 3, 2012

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    FDA Enforcement
    Class II ·Terminated·Isopure Corp·September 21, 2022