BEUDAMED
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    Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

    FDA Enforcement
    Class II ·Terminated·Covidien LP·June 27, 2012

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    FDA Enforcement
    Class II ·Terminated·Medtronic·December 28, 2016

    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·December 19, 2019

    Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    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

    Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code NWB·December 17, 2018

    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