BEUDAMED
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    SUBCLAVIAN JUGULAR CATHETER SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    STRYKER CORPORATION·07613154410422·1.6mm Lindemann Drill Bit

    NA

    FDA UDI
    STRYKER CORPORATION·07613153022466·2.3mm Tapered Serrated Drill Bit

    IQTEQ SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MOST-T Autoclave

    FDA 510(k)
    FDA Class 2 ·General Hospital

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 20, 2014

    PHYSIOMESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·November 6, 2012

    MIKA KNEE

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code LXH·August 24, 2010

    Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 18, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021