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"
49–72 of 102
Search insights Median review: 103d Cleared: 99% Top manufacturer: Covidien, LLC Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2018
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal...
K180485 · FJS
Covidien, LLC
Gastroenterology & Urology · 154d
Cleared Apr 26, 2018
Beacon EUS Access System
K180037 · FCG
Covidien, LLC
Gastroenterology & Urology · 111d
Cleared Mar 26, 2018
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision...
K180149 · LFL
Covidien, LLC
General & Plastic Surgery · 66d
Cleared Mar 21, 2018
Emprint Ablation Visualization Application
K180192 · LLZ
Covidien, LLC
Radiology · 56d
Cleared Feb 08, 2018
superDimension Navigation System V7.2
K173244 · JAK
Covidien, LLC
Radiology · 125d
Cleared Jan 18, 2018
Barrx SB RFA Endoscopic Catheter
K173559 · KNS
Covidien, LLC
Gastroenterology & Urology · 62d
Cleared Nov 02, 2017
Valleylab FX8 Electrosurgical Platform
K172757 · GEI
Covidien, LLC
General & Plastic Surgery · 50d
Cleared Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K171066 · GEI
Covidien, LLC
General & Plastic Surgery · 59d
Cleared Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537 · EOQ
Covidien, LLC
Ear, Nose, Throat · 126d
Cleared Mar 08, 2017
VersaOne fascial closure system bladed trocar, VersaOne fascial closure...
K163654 · GCJ
Covidien, LLC
General & Plastic Surgery · 75d
Cleared Feb 16, 2017
Valleylab FT10 Electrosurgical Platform
K170170 · GEI
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Jan 24, 2017
Barrx Anorectal RFA Wand
K162802 · GEI
Covidien, LLC
General & Plastic Surgery · 111d
Cleared Dec 06, 2016
Emprint Ablation System
K163105 · NEY
Covidien, LLC
General & Plastic Surgery · 29d
Cleared Dec 05, 2016
Tri-Staple 2.0 Intelligent Cartridge
K163098 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared May 19, 2016
Valleylab REM Polyhesive Infant Patient Return Electrode
K160290 · GEI
Covidien, LLC
General & Plastic Surgery · 106d
Cleared May 04, 2016
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654 · KNT
Covidien, LLC
Gastroenterology & Urology · 57d
Cleared Apr 12, 2016
Cytosponge Cell Collection Device
K152794 · EOX
Covidien, LLC
Ear, Nose, Throat · 197d
Cleared Apr 05, 2016
Barrx FLEX RFA Energy Generator
K160360 · GEI
Covidien, LLC
General & Plastic Surgery · 56d
Cleared Mar 28, 2016
Sonicision Cordless Ultrasonic Dissection Device
K153371 · LFL
Covidien, LLC
General & Plastic Surgery · 126d
Cleared Dec 30, 2015
Beacon Fine Needle Fiducial System
K152586 · NEU
Covidien, LLC
General & Plastic Surgery · 111d
Cleared Nov 05, 2015
superDimension Navigation System
K151376 · JAK
Covidien, LLC
Radiology · 167d
Cleared Jul 28, 2015
Barrx Anorectal RFA Wand
K150251 · GEI
Covidien, LLC
General & Plastic Surgery · 175d
Cleared Jul 17, 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase...
K151659 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared Jun 18, 2015
Spacemaker Pro Access and Dissector System
K151356 · GCJ
Covidien, LLC
General & Plastic Surgery · 29d