BEUDAMED
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    Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·EINO2308879·Universal Guide Tube MicroDrive for micro and D...

    S4C NAVIGATION INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEKTROGEL, MODEL LK3001

    FDA 510(k)
    FDA Class 2 ·Neurology

    EQUINOXE CAGE GLENOID M, POST AUG, RIGHT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·July 26, 2023

    SOFTCLIX PLUS LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·November 6, 2008

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 1, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018