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

Covidien, LLC has 86 FDA 510(k) cleared medical devices. Based in Mansfield, US.

Latest FDA clearance: Jun 2026. Active since 2010. Primary specialty: General & Plastic Surgery.

Browse the FDA 510(k) cleared devices submitted by Covidien, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Kompass Regulatory Consulting, LLC as regulatory consultant. 2 devices have linked clinical trials registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Covidien, LLC

89 devices
1-12 of 89
Cleared Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
K253984 · SFE
General & Plastic Surgery · 174d
Cleared May 01, 2026
Capnostream™35 Portable Respiratory Monitor (PM35MN)
K253030 · CCK
Anesthesiology · 224d
Cleared Dec 29, 2025
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041,...
K251025 · BZT
Anesthesiology · 271d
Cleared Dec 29, 2025
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal...
K251313 · JOH
Anesthesiology · 245d
Cleared CT Dec 03, 2025
Hugo™ RAS System
K250725 · SCV
General & Plastic Surgery · 268d
Cleared Oct 06, 2025
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal...
K250173 · BTR
Anesthesiology · 258d
Cleared Sep 25, 2025
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye...
K243785 · BTR
Anesthesiology · 290d
Cleared Jul 12, 2024
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN...
K241085 · GEI
General & Plastic Surgery · 84d
Cleared Jul 01, 2024
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m)...
K240572 · GEI
General & Plastic Surgery · 123d
Cleared May 20, 2024
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430,...
K233341 · BTR
Anesthesiology · 234d
Cleared Feb 26, 2024
BIS™ Advance Monitoring System
K230693 · OLW
Anesthesiology · 350d
Cleared Jul 21, 2023
EndoflipTM 300 System
K231861 · FFX
Gastroenterology & Urology · 28d

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