Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

46 results for "Pentax of America, Inc."
25–46 of 46
Cleared Dec 20, 2019
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI...
K190805 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 22, 2019
C2 CryoBalloon EndoGrip
K193036 · OCX
Pentax Medical, A Division of Pentax...
General & Plastic Surgery · 22d
Cleared Nov 15, 2019
Pentax Medical Video Duodenoscope ED34-i10T2
K192245 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 12, 2019
PENTAX Medical Video Upper GI Scopes (EG Family)
K190799 · FDS
Pentax of America, Inc.
Gastroenterology & Urology · 229d
Cleared Nov 08, 2019
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
K191282 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 179d
Cleared Sep 06, 2019
PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K183516 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 262d
Cleared Jun 12, 2019
PENTAX Medical ENT Video Imaging System
K183691 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 163d
Cleared May 31, 2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon...
K190194 · GEH
Pentax Medical, A Division of Pentax...
General & Plastic Surgery · 116d
Cleared May 23, 2019
PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and...
K183654 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 147d
Cleared Jan 18, 2019
PENTAX Video Colonoscopes (EC Family)
K181084 · FDF
Pentax of America, Inc.
Gastroenterology & Urology · 269d
Cleared Jan 09, 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 92d
Cleared Aug 21, 2018
PENTAX Medical Endoscopic Ultrasound System
K182004 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 09, 2018
PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video...
K181522 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 03, 2018
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173679 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 214d
Cleared Jan 19, 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video...
K173554 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Apr 20, 2017
PENTAX Medical ENT Video Imaging System
K162151 · EOB
Pentax of America, Inc.
Ear, Nose, Throat · 261d
Cleared Apr 13, 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope...
K162447 · ODG
Pentax of America, Inc.
Gastroenterology & Urology · 224d
Cleared Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 259d
Cleared Oct 29, 2015
PENTAX Medical EKP-i5010 Video Processor with EB Family
K143727 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 304d
Cleared Mar 20, 2013
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130247 · ODG
Pentax of America, Inc.
Radiology · 47d
Cleared Mar 20, 2013
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130206 · ODG
Pentax of America, Inc.
Radiology · 51d
Cleared Jun 22, 2012
PENTAX EPK-I5020 VIDEO PROCESSOR
K113873 · FET
Pentax of America, Inc.
Gastroenterology & Urology · 175d