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

300 results for "Covidien"
169–192 of 300
Search insights Median review: 102d Cleared: 100% Top manufacturer: Covidien Lead specialty: General & Plastic Surgery
Cleared CT Mar 05, 2015
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · DQA
Covidien
Anesthesiology · 269d
Cleared Feb 25, 2015
GastriSail Gastric Positioning System
K143088 · KNT
Covidien
Gastroenterology & Urology · 120d
Cleared Feb 24, 2015
Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula
K142296 · JOH
Covidien
Anesthesiology · 190d
Cleared Feb 23, 2015
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 102d
Cleared Feb 23, 2015
KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
K142128 · PNR
Covidien
Gastroenterology & Urology · 203d
Cleared Feb 13, 2015
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with...
K142298 · JOH
Covidien
Anesthesiology · 179d
Cleared Jan 29, 2015
Surgical Gut Suture
K142656 · GAL
Covidien
General & Plastic Surgery · 133d
Cleared Jan 27, 2015
Ligasure Blunt Tip Sealer/Divider
K142929 · GEI
Covidien
General & Plastic Surgery · 110d
Cleared Jan 14, 2015
RapidVac Smoke Evacuator System
K142335 · FYD
Covidien
General Hospital · 146d
Cleared Dec 23, 2014
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · LZH
Covidien
General Hospital · 202d
Cleared Dec 19, 2014
Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)
K143161 · GEI
Covidien
General & Plastic Surgery · 46d
Cleared Dec 09, 2014
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
K142547 · GCJ
Covidien
General & Plastic Surgery · 90d
Cleared Nov 26, 2014
Surgisleeve Wound Protector
K143091 · GCJ
Covidien, LLC
General Hospital · 29d
Cleared Nov 26, 2014
Cytosponge Cell Collection Device
K142695 · EOX
Covidien, LLC
Ear, Nose, Throat · 65d
Cleared Nov 14, 2014
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh),...
K142908 · FTL
Sofradim Production
General & Plastic Surgery · 39d
Cleared Oct 30, 2014
Premium Surgiclip III
K142869 · FZP
Covidien
General & Plastic Surgery · 29d
Cleared Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh),...
K142900 · FTL
Sofradim Production
General & Plastic Surgery · 22d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Covidien, LLC
Cardiovascular · 40d
Cleared Oct 16, 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · MCW
Covidien, LLC
Cardiovascular · 105d
Cleared Oct 08, 2014
BNX Fine Needle Aspiration System
K142198 · NEU
Covidien, LLC
General & Plastic Surgery · 58d
Cleared Oct 06, 2014
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K141894 · FCG
Covidien, LLC( Formerly Beacon...
Gastroenterology & Urology · 84d
Cleared Oct 02, 2014
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · DQA
Covidien, LLC
Anesthesiology · 114d
Cleared Oct 01, 2014
Barrx RFA Self Sizing Balloon Catheter
K142364 · GEI
Covidien, LLC
General & Plastic Surgery · 37d
Cleared Sep 17, 2014
EMPRINT PROCEDURE PLANNING APPLICATION
K142048 · LLZ
Covidien, LLC
Radiology · 51d