Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

46 results for "Pentax of America, Inc."
25–46 of 46
Search insights Median review: 159d Cleared: 100% Top manufacturer: Pentax of America, Inc. Lead specialty: Gastroenterology & Urology
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