Covidien, LLC - FDA 510(k) Cleared Devices
Recent clearances: Instrument Exit Point on Touch Surgery™ Aide, Capnostream™35 Portable Respiratory Monitor (PM35MN), Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
89
Total
86
Cleared
1
Denied
FDA 510(k) Regulatory Record - Covidien, LLC Ear, Nose, Throat ✕
7 devices
Cleared
Mar 02, 2020
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Ear, Nose, Throat
89d
Cleared
Nov 06, 2018
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Ear, Nose, Throat
60d
Cleared
Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
Ear, Nose, Throat
126d
Cleared
Apr 12, 2016
Cytosponge Cell Collection Device
Ear, Nose, Throat
197d
Cleared
Apr 29, 2015
GenCut Core Biopsy System
Ear, Nose, Throat
211d
Cleared
Nov 26, 2014
Cytosponge Cell Collection Device
Ear, Nose, Throat
65d
Cleared
Nov 06, 2013
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
Ear, Nose, Throat
266d