FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

299 results for "Covidien"
169–192 of 299
Search insights Median review: 102d Cleared: 100% Top manufacturer: Covidien Lead specialty: General & Plastic Surgery
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
Cleared Aug 21, 2014
BARRX FLEX RFA ENERGY GENERATOR
K141357 · GEI
Covidien Iic
General & Plastic Surgery · 90d