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    DISPOSABLE SCALP VEIN INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    U-CLIP DEVICE, MODELS B140, B160 AND B180

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

    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 24, 2017

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·February 9, 2013

    UNIFY CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 23, 2014

    RENAL-DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 7, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·August 8, 2025

    enGen Track System with TCAutomation Software Version 4.2

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·December 20, 2017

    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 4, 2016