Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of HOYALabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Pentax Medical with 26 device recalls and 20 510(k) clearances. The most recent is a 510(k) clearance dated Nov 22, 2019: C2 CryoBalloon EndoGrip.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Nov 22, 2019 | C2 CryoBalloon EndoGripK193036 · OCX | 510(k) clearances |
| Oct 21, 2019 | PENTAX Medical ED-3490TK Video DuodenoscopeK192280 · FDT | 510(k) clearances |
| May 31, 2019 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon CartridgeK190194 · GEH | 510(k) clearances |
| Jul 18, 2018 | PENTAX Medical VIVIDEO ENT Videoscope SolutionK171011 · EOB | 510(k) clearances |
| Apr 5, 2018 | PENTAX Medical EPK-3000 Video Imaging SystemK172156 · EOB | 510(k) clearances |
| Feb 7, 2018 | PENTAX MEDICAL ED-3490TK, Video DuodenoscopeK161222 · FDT | 510(k) clearances |
| Sep 20, 2017 | PENTAX Medical ED34-i10T, Video DuodenoscopeK163614 · FDT | 510(k) clearances |
| Apr 6, 2016 | Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. ThisClass II · Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) w | Device recalls |
| Apr 6, 2016 | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. ThisClass II · Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) w | Device recalls |
| Apr 6, 2016 | Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access Class II · Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) w | Device recalls |
| Apr 6, 2016 | Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. ThisClass II · Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) w | Device recalls |
| Apr 6, 2016 | Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatClass II · Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) w | Device recalls |
| Apr 6, 2016 | Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. ThisClass II · Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) w | Device recalls |
| Apr 6, 2016 | Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, bClass II · Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, et | Device recalls |
| Apr 6, 2016 | Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes,Class II · Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, et | Device recalls |
| Apr 25, 2014 | ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUSK131946 · EOQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
