Covidien, LLC FDA Approvals

0 new drug approvals and 27 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated510(k)Sep 15, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 15, 2026
Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)510(k)Jul 1, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
Instrument Exit Point on Touch Surgery Aide510(k)Jun 4, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jun 4, 2026
Capnostream35 Portable Respiratory Monitor (PM35MN)510(k)May 1, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 1, 2026
Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)510(k)Dec 29, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 29, 2025
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 XLT510(k)Dec 29, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Dec 29, 2025
Hugo RAS System510(k)Dec 3, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Dec 3, 2025
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)510(k)Oct 6, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Oct 6, 2025
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 Reinforced510(k)Sep 25, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2025
Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)510(k)Jul 12, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 12, 2024
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)510(k)Jul 1, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jul 1, 2024
Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)510(k)May 20, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 20, 2024
BIS Advance Monitoring System510(k)Feb 26, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 26, 2024
EndoflipTM 300 System510(k)Jul 21, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jul 21, 2023
EndoflipTM 300510(k)Apr 14, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Apr 14, 2023
LigaSure XP Maryland Jaw Sealer/Divider510(k)Jan 23, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 23, 2023
Microstream CO2 NanoPod510(k)Jul 29, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2022
ProdiGI510(k)Jun 13, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Unknown (Direct)	Jun 13, 2022
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC510(k)May 6, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 6, 2022
CARESCAPE CO2 Microstream parameter510(k)Apr 12, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 12, 2022
Cool-tip RF Ablation System E Series510(k)Feb 25, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 25, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit510(k)Jan 14, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jan 14, 2022
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)510(k)Dec 5, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 5, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device510(k)Nov 15, 2021	—	510(k)Substantially Equivalent (Traditional)	Nov 15, 2021
Edge Insulated Blade Electrode510(k)Apr 15, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 15, 2021
LigaSure Exact Dissector, Nano-coated510(k)Mar 23, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Mar 23, 2021
Puritan Bennett Cuff Pressure Manager510(k)Jan 9, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 9, 2021

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