170 results · 12ms · Sources: EU EUDAMED, US FDA

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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

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