BEUDAMED
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    VersaPump Infusion System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925018990·REPLACEMENT RICHARDS ADAPTOR

    OMNILUX BLUE

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

    SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEAD MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 6, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 1, 2011

    OT ULTRALINK METER

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

    ALARIS® SYRINGE MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FRN·August 26, 2016

    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