BEUDAMED
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    MAHURKAR 8 FR DUAL LEMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ANTI-E (MONOCLONAL) SERIES 1

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·April 23, 2010

    KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SINGLE USE MANUAL RESUSCITATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EXACTECH

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·May 24, 2022

    EXACTECH

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·May 24, 2022

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 11, 2013

    REMB OSC SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 24, 2014

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015