Covidien, LLC - FDA 510(k) Cleared Devices
Recent clearances: Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT), Instrument Exit Point on Touch Surgery™ Aide, Capnostream™35 Portable Respiratory Monitor (PM35MN)
90
Total
87
Cleared
1
Denied
FDA 510(k) Regulatory Record - Covidien, LLC Cardiovascular ✕
4 devices
Cleared
Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
Cardiovascular
40d
Cleared
Oct 16, 2014
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Cardiovascular
105d
Cleared
Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
Cardiovascular
28d
Cleared
Oct 19, 2010
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Cardiovascular
27d