Pentax of America, Inc. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
FDA 510(k) cleared devices by Pentax of America, Inc. Ear, Nose, Throat ✕
14 devices
Cleared
Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
Ear, Nose, Throat
125d
Cleared
Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
Ear, Nose, Throat
193d
Cleared
Dec 21, 2022
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
Ear, Nose, Throat
447d
Cleared
Dec 02, 2022
PENTAX Medical Video Esophagoscope EE17-J10
Ear, Nose, Throat
63d
Cleared
Nov 16, 2022
PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX...
Ear, Nose, Throat
272d
Cleared
Oct 21, 2021
PENTAX Medical Video Bronchoscope EB11-J10
Ear, Nose, Throat
206d
Cleared
Jul 30, 2020
PENTAX Medical Video Bronchoscope EB-J10 Series
Ear, Nose, Throat
136d
Cleared
Sep 06, 2019
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
Ear, Nose, Throat
262d
Cleared
Jun 12, 2019
PENTAX Medical ENT Video Imaging System
Ear, Nose, Throat
163d
Cleared
May 23, 2019
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and...
Ear, Nose, Throat
147d
Cleared
Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
Ear, Nose, Throat
92d
Cleared
Jan 19, 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video...
Ear, Nose, Throat
63d
Cleared
Apr 20, 2017
PENTAX Medical ENT Video Imaging System
Ear, Nose, Throat
261d
Cleared
Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
Ear, Nose, Throat
304d