Medical Device Manufacturer · US , Mansfield , MA

Covidien, LLC - FDA 510(k) Cleared Devices

89 submissions · 86 cleared · Since 2010

Recent clearances: Instrument Exit Point on Touch Surgery™ Aide, Capnostream™35 Portable Respiratory Monitor (PM35MN), Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

89

Total

86

Cleared

1

Denied

FDA 510(k) Regulatory Record - Covidien, LLC Radiology ✕

6 devices

1-6 of 6

Cleared Dec 02, 2019

Emprint Visualization Application

Radiology · 125d

Cleared Aug 07, 2019

ILLUMISITE Platform

Radiology · 75d

Cleared Mar 21, 2018

Emprint Ablation Visualization Application

Radiology · 56d

Cleared Feb 08, 2018

superDimension Navigation System V7.2

Radiology · 125d

Cleared Nov 05, 2015

superDimension Navigation System

Radiology · 167d

Cleared Sep 17, 2014

EMPRINT PROCEDURE PLANNING APPLICATION

Radiology · 51d