BEUDAMED
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    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    FDA Recall
    Terminated ·Organ Recovery Systems, Inc.·Product code KDN·January 30, 2020

    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    FDA Enforcement
    Class II ·Terminated·Organ Recovery Systems, Inc.·March 11, 2020

    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.

    FDA Recall
    Terminated ·Konica Minolta Healthcare, Americas, Inc.·Product code IXY·November 8, 2018

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew, Inc.·October 1, 2014

    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

    FDA Enforcement
    Class II ·Terminated·U-systems Inc·July 3, 2013

    lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

    FDA Enforcement
    Class II ·Terminated·Invatec Llc·June 12, 2013

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.

    FDA Recall
    Terminated ·U-systems Inc·Product code PAA·May 16, 2013

    iPico Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Perfector Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    Ion Magnum Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OMP·August 13, 2014

    IELLIOS Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code NFO·January 6, 2012

    Arasys Product Usage: Muscle stimulation

    FDA Recall
    Terminated ·Ion Genius, Inc.·Product code IPF·January 6, 2012

    lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Medtronic Endovascular Therapies, Santa Rosa, CA The Diver C.E. product is an aspiration catheter indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

    FDA Recall
    Terminated ·Invatec Llc·Product code DXE·March 4, 2009

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·September 23, 2011

    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"

    FDA Recall
    Terminated ·Harris Medical Resources·Product code MXG·May 13, 2010

    MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·February 13, 2014

    Axiom Aristos TX. Model number 58 94 873 Radiology system

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code KPR·June 10, 2005