BEUDAMED
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    CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AGXO

    FDA UDI
    Oticon A/S·05707131258342·H160, RITE 312 WL DBL AGXO

    NAVIGATOR APPLICATIONS SUITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURGICASE CONNECT, SURGICASE GUIDE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORTIFY VR, U1.6 DF1 ID

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code LWS·December 5, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 13, 2011

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 23, 2024

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014