BEUDAMED
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    QUANTEX IGA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111024·INSTRUMENT CADDY MEDIUM

    Randox RX Daytona Plus Magnesium (MG)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE X-STOP® INTERSPINOUS SPACER SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NQO·February 14, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 28, 2014

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 17, 2011

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021