Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

102 results for "Covidien, LLC"
1–24 of 102
Search insights Median review: 103d Cleared: 99% Top manufacturer: Covidien, LLC Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2026
LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
K261070 · GEI
Covidien, LLC
General & Plastic Surgery · 167d
Cleared Jul 01, 2026
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)
K253527 · GAG
Covidien, LLC
General & Plastic Surgery · 230d
Cleared Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
K253984 · SFE
Covidien, LLC
General & Plastic Surgery · 174d
Cleared May 28, 2026
Trexon™ Monofilament Synthetic Absorbable Suture
K253530 · GAM
Medtronic
General & Plastic Surgery · 196d
Cleared May 01, 2026
Capnostream™35 Portable Respiratory Monitor (PM35MN)
K253030 · CCK
Covidien, LLC
Anesthesiology · 224d
Cleared Dec 29, 2025
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal...
K251313 · JOH
Covidien, LLC
Anesthesiology · 245d
Cleared Dec 29, 2025
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041,...
K251025 · BZT
Covidien, LLC
Anesthesiology · 271d
Cleared CT Dec 03, 2025
Hugo™ RAS System
K250725 · SCV
Covidien, LLC
General & Plastic Surgery · 268d
Cleared Oct 06, 2025
Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal...
K250173 · BTR
Covidien, LLC
Anesthesiology · 258d
Cleared Sep 25, 2025
Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye...
K243785 · BTR
Covidien, LLC
Anesthesiology · 290d
Cleared Apr 23, 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · FTL
Sofradim Production
General & Plastic Surgery · 30d
Cleared Jan 17, 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · FTL
Sofradim Production
General & Plastic Surgery · 87d
Cleared Jul 12, 2024
Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN...
K241085 · GEI
Covidien, LLC
General & Plastic Surgery · 84d
Cleared Jul 01, 2024
Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m)...
K240572 · GEI
Covidien, LLC
General & Plastic Surgery · 123d
Cleared May 20, 2024
Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430,...
K233341 · BTR
Covidien, LLC
Anesthesiology · 234d
Cleared Feb 26, 2024
BIS™ Advance Monitoring System
K230693 · OLW
Covidien, LLC
Anesthesiology · 350d
Cleared Jan 18, 2024
Progrip™ Self-Gripping Polypropylene Mesh
K232373 · FTL
Sofradim Production
General & Plastic Surgery · 163d
Cleared Jul 21, 2023
EndoflipTM 300 System
K231861 · FFX
Covidien, LLC
Gastroenterology & Urology · 28d
Cleared Apr 14, 2023
EndoflipTM 300
K223705 · FFX
Covidien, LLC
Gastroenterology & Urology · 123d
Cleared Jan 23, 2023
LigaSure™ XP Maryland Jaw Sealer/Divider
K223158 · GEI
Covidien, LLC
General & Plastic Surgery · 108d
Cleared Jul 29, 2022
Microstream CO2 NanoPod
K213911 · CCK
Covidien, LLC
Anesthesiology · 226d
Cleared Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex...
K220586 · FTL
Sofradim Production
General & Plastic Surgery · 113d
Not Cleared Jun 13, 2022
ProdiGI
DEN220006 · QSW
Covidien, LLC
Gastroenterology & Urology · 150d
Cleared CT May 06, 2022
Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft...
K212555 · DQA
Covidien, LLC
Anesthesiology · 266d