Covidien, LLC - FDA 510(k) Cleared Devices
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 Anesthesiology ✕
16 devices
Cleared
May 01, 2026
Capnostream™35 Portable Respiratory Monitor (PM35MN)
Anesthesiology
224d
Cleared
Dec 29, 2025
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041,...
Anesthesiology
271d
Cleared
Dec 29, 2025
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal...
Anesthesiology
245d
Cleared
Oct 06, 2025
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal...
Anesthesiology
258d
Cleared
Sep 25, 2025
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye...
Anesthesiology
290d
Cleared
May 20, 2024
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430,...
Anesthesiology
234d
Cleared
Feb 26, 2024
BIS™ Advance Monitoring System
Anesthesiology
350d
Cleared
Jul 29, 2022
Microstream CO2 NanoPod
Anesthesiology
226d
Cleared
CT
May 06, 2022
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft...
Anesthesiology
266d
Cleared
Apr 12, 2022
CARESCAPE CO2 Microstream parameter
Anesthesiology
160d
Cleared
Jan 09, 2021
Puritan Bennett Cuff Pressure Manager
Anesthesiology
103d
Cleared
Nov 20, 2020
Puritan Bennett 980 Series Ventilator System
Anesthesiology
385d
Cleared
Jul 20, 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
Anesthesiology
80d
Cleared
Mar 26, 2015
Nellcor Bedside SpO2 Patient Monitoring System
Anesthesiology
177d
Cleared
Oct 02, 2014
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
Anesthesiology
114d
Cleared
Jul 10, 2012
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
Anesthesiology
118d