Medical Device Manufacturer · US , Mansfield , MA

Covidien, LLC

87 submissions · 84 cleared · Since 2010
87
Total
84
Cleared
1
Denied

Covidien, LLC — FDA 510(k) Submissions

Covidien, LLC has submitted 87 FDA 510(k) premarket notifications since 2010, of which 84 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Staple, Implantable, System, Ablation, Microwave And Accessories, Oximeter, Instrument, Ultrasonic Surgical . Use the specialty filter in the sidebar to narrow results.

87 devices
1–25 of 87
Mon-a-Therm? Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
K251025 · BZT Stethoscope, Esophageal,... · Anesthesiology
Dec 2025 271d
Shiley? Adult Flexible Tracheostomy Tube XLT with TaperGuard? Cuff, Distal with Disposable Inner Cannula; Shiley? Adult Flexible Tracheostomy Tube XLT with TaperGuard? Cuff, Proximal with Disposable Inner Cannula; Shiley? Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley? Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley? Adult Flexible Disposable Inner Cannula XLT
K251313 · JOH Tube Tracheostomy And... · Anesthesiology
Dec 2025 245d
Hugo? RAS System
K250725 · SCV Modular Electromechanical... · General & Plastic Surgery
Dec 2025 268d
Shiley? Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley? Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley? Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley? Oral RAE Tracheal Tube with TaperGuard? Cuff, Murphy Eye (115-XXOR) Shiley? Nasal RAE Tracheal Tube with TaperGuard? Cuff, Murphy Eye (119-XXNR)
K250173 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Oct 2025 258d
Shiley? Oral/Nasal Tracheal Tube with TaperGuard? Cuff Reinforced, Murphy Eye Shiley? Tracheal Tube TaperGuard? Cuff Reinforced with Stylet Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley? Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley? Oral/Nasal Tracheal Tube Cuffless Reinforced
K243785 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Sep 2025 290d
Valleylab ?FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
K241085 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2024 84d
Valleylab? SM Smoke Management Pencil with Edge? Blade Electrode, 10? (3m) (VSMP10); Valleylab? SM Smoke Management Pencil with Edge? Blade Electrode, 15? (4.6m) (VSMP15); Valleylab? SM Smoke Management Pencil with Edge? Blade Electrode, 10? (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab? SM Smoke Management Extended Nozzle (for use with 4? (100mm) electrode) (VSMEN4); Valleylab? SM Smoke Management Extended Nozzle (for use with 6.5? (165mm) electrode) (VSMEN6)
K240572 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2024 123d
Shiley? Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
K233341 · BTR Tube, Tracheal (w/wo... · Anesthesiology
May 2024 234d
BIS? Advance Monitoring System
K230693 · OLW Index-generating... · Anesthesiology
Feb 2024 350d
EndoflipTM 300 System
K231861 · FFX System, Gastrointestinal... · Gastroenterology & Urology
Jul 2023 28d
EndoflipTM 300
K223705 · FFX System, Gastrointestinal... · Gastroenterology & Urology
Apr 2023 123d
LigaSure? XP Maryland Jaw Sealer/Divider
K223158 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jan 2023 108d
Microstream CO2 NanoPod
K213911 · CCK Analyzer, Gas,... · Anesthesiology
Jul 2022 226d
ProdiGI
DEN220006 · QSW Endoscopic Traction Device · Gastroenterology & Urology
Jun 2022 150d
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
K212555 · DQA Oximeter · Anesthesiology
May 2022 266d
CARESCAPE CO2 Microstream parameter
K213518 · CCK Analyzer, Gas,... · Anesthesiology
Apr 2022 160d
Cool-tip RF Ablation System E Series
K203150 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2022 491d
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
K213602 · FJS Catheter, Peritoneal,... · Gastroenterology & Urology
Jan 2022 60d
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
K211561 · MUD Oximeter, Tissue Saturation · Neurology
Dec 2021 199d
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Nov 2021 115d
Edge Insulated Blade Electrode
K210338 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2021 69d
LigaSure Exact Dissector, Nano-coated
K202917 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2021 175d
Puritan Bennett Cuff Pressure Manager
K202874 · BSK Cuff, Tracheal Tube,... · Anesthesiology
Jan 2021 103d
Emprint SX Ablation Platform with Thermosphere Technology
K203303 · NEY System, Ablation,... · General & Plastic Surgery
Dec 2020 38d
Puritan Bennett 980 Series Ventilator System
K193056 · CBK Ventilator, Continuous,... · Anesthesiology
Nov 2020 385d

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