BEUDAMED
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    UNIFINE PENTIPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    REVISED LABELING FOR SYVA METHADONE ASSAYS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CIAGLIA BLUE RHINO TRACHEOSTOMY TUBE

    FDA Adverse Event
    COOK MEDICAL INC.·Product code JOH·February 13, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·January 20, 2011

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 1, 2014

    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·April 16, 2015

    NIM TRIVANTAGE EMG Endotracheal Tube

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·December 22, 2021

    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·July 14, 2014

    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·November 9, 2012

    SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code LKK·November 9, 2012