Medical Device Manufacturer · US , Mansfield , MA

Covidien, LLC - FDA 510(k) Cleared Devices

88 submissions · 85 cleared · Since 2010
88
Total
85
Cleared
1
Denied
88 devices
51-75 of 88
Cleared Dec 06, 2016
Emprint Ablation System
K163105 · NEY
General & Plastic Surgery · 29d
Cleared Dec 05, 2016
Tri-Staple 2.0 Intelligent Cartridge
K163098 · GDW
General & Plastic Surgery · 28d
Cleared May 19, 2016
Valleylab REM Polyhesive Infant Patient Return Electrode
K160290 · GEI
General & Plastic Surgery · 106d
Cleared May 04, 2016
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654 · KNT
Gastroenterology & Urology · 57d
Cleared Apr 12, 2016
Cytosponge Cell Collection Device
K152794 · EOX
Ear, Nose, Throat · 197d
Cleared Apr 05, 2016
Barrx FLEX RFA Energy Generator
K160360 · GEI
General & Plastic Surgery · 56d
Cleared Mar 28, 2016
Sonicision Cordless Ultrasonic Dissection Device
K153371 · LFL
General & Plastic Surgery · 126d
Cleared Dec 30, 2015
Beacon Fine Needle Fiducial System
K152586 · NEU
General & Plastic Surgery · 111d
Cleared Nov 05, 2015
superDimension Navigation System
K151376 · JAK
Radiology · 167d
Cleared Jul 28, 2015
Barrx Anorectal RFA Wand
K150251 · GEI
General & Plastic Surgery · 175d
Cleared Jul 17, 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase...
K151659 · GDW
General & Plastic Surgery · 28d
Cleared Jun 18, 2015
Spacemaker Pro Access and Dissector System
K151356 · GCJ
General & Plastic Surgery · 29d
Cleared May 29, 2015
Signia Loading Unit, Tri-Staple 2.0 Cartridge
K151163 · GDW
General & Plastic Surgery · 28d
Cleared Apr 29, 2015
GenCut Core Biopsy System
K142839 · EOQ
Ear, Nose, Throat · 211d
Cleared Apr 03, 2015
Valleylab LS10 Generator
K143654 · GEI
General & Plastic Surgery · 101d
Cleared Mar 26, 2015
Nellcor Bedside SpO2 Patient Monitoring System
K142865 · DQA
Anesthesiology · 177d
Cleared Mar 12, 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598 · FZP
General & Plastic Surgery · 84d
Cleared Nov 26, 2014
Cytosponge Cell Collection Device
K142695 · EOX
Ear, Nose, Throat · 65d
Cleared Nov 26, 2014
Surgisleeve Wound Protector
K143091 · GCJ
General Hospital · 29d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Cardiovascular · 40d
Cleared Oct 16, 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · MCW
Cardiovascular · 105d
Cleared Oct 08, 2014
BNX Fine Needle Aspiration System
K142198 · NEU
General & Plastic Surgery · 58d
Cleared Oct 02, 2014
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · DQA
Anesthesiology · 114d
Cleared Oct 01, 2014
Barrx RFA Self Sizing Balloon Catheter
K142364 · GEI
General & Plastic Surgery · 37d
Cleared Sep 17, 2014
EMPRINT PROCEDURE PLANNING APPLICATION
K142048 · LLZ
Radiology · 51d

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