BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    MEDTRONIC INPUT PS INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WU'S 4-WHEELED SCOOTER, WT-L4JR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AUDIT MICROCV CARDIAC MARKERS LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OT ULTRAMINI METER

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 17, 2011

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCW·August 22, 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

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018