BEUDAMED
    152 results · 12ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

    FDA Recall
    Terminated ·Dexcom Inc·Product code PQF·February 3, 2020

    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

    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

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLG·June 26, 2020

    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

    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