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    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 27, 2012

    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

    FDA Recall
    Terminated ·Visicu, Inc.·Product code MSX·March 27, 2015

    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code PHV·August 5, 2016

    Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.

    FDA Recall
    Terminated ·Data Innovations, Inc.·Product code JQP·May 11, 2009

    Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

    FDA Recall
    Terminated ·Innovasis, Inc·Product code NKB·January 8, 2018

    AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007

    FDA Recall
    Terminated ·AdvanDx, Inc.·Product code JSS·October 6, 2010

    Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019

    Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSN·March 8, 2019