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    EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arx

    FDA UDI
    Life Spine, Inc.·00190837035396·ARX Reducer

    E.M. Adams Co Inc

    FDA UDI
    E.M. ADAMS, INC.·10840200301081·LACERATION TRAY

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·18100013401081·LACERATION PACK

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

    IDEAL IQ SOFTWARE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PULPDENT CAVITY PREPARATION IV

    FDA 510(k)
    FDA Class 2 ·Dental

    BENCHMARK GX, STAINER MODULE

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 18, 2024

    PLATE, FIXATION BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 30, 2015

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    ZIMMER AIR DERMATOME

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code GFD·May 20, 2019

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024