BEUDAMED
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    EasyMark Tissue Marker

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304680630·

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145414·.13/.04/31mm ZenFlex CM NiTi FILE REFILL PACK

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304647879·

    DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRAD30003/RADREX-I

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 29, 2011

    EXPRESS BILIARY SD-MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 23, 2008

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021