Pentax of America, Inc. - FDA 510(k) Cleared Devices
44
Total
44
Cleared
0
Denied
44 devices
Cleared
Nov 15, 2019
Pentax Medical Video Duodenoscope ED34-i10T2
Gastroenterology & Urology
88d
Cleared
Nov 12, 2019
PENTAX Medical Video Upper GI Scopes (EG Family)
Gastroenterology & Urology
229d
Cleared
Nov 08, 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
Gastroenterology & Urology
179d
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 18, 2019
PENTAX Video Colonoscopes (EC Family)
Gastroenterology & Urology
269d
Cleared
Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
Ear, Nose, Throat
92d
Cleared
Aug 21, 2018
PENTAX Medical Endoscopic Ultrasound System
Gastroenterology & Urology
25d
Cleared
Jul 09, 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video...
Gastroenterology & Urology
28d
Cleared
Jul 03, 2018
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
Gastroenterology & Urology
214d
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
Apr 13, 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope...
Gastroenterology & Urology
224d
Cleared
Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
Gastroenterology & Urology
259d
Cleared
Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
Ear, Nose, Throat
304d
Cleared
Mar 20, 2013
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
Radiology
51d
Cleared
Mar 20, 2013
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
Radiology
47d
Cleared
Jun 22, 2012
PENTAX EPK-I5020 VIDEO PROCESSOR
Gastroenterology & Urology
175d