| Z-2329-2025 | Class II | Pentax Medical Video Processor; Model Number: EPK-i8020c; | July 16, 2025 |
| Z-1237-2025 | Class II | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monito | January 29, 2025 |
| Z-1236-2025 | Class II | PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor | January 29, 2025 |
| Z-1238-2025 | Class II | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and oth | January 29, 2025 |
| Z-2449-2021 | Class II | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K | July 14, 2021 |
| Z-2448-2021 | Class II | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water | July 14, 2021 |
| Z-1682-2021 | Class II | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and o | April 21, 2021 |
| Z-0292-2021 | Class II | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | September 22, 2020 |
| Z-0293-2021 | Class II | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoP | September 22, 2020 |
| Z-1268-2020 | Class II | Pentax Video Colonoscope Model: EC38-i10L | January 3, 2020 |
| Z-1267-2020 | Class II | Pentax Video Colonoscope Model: EC34-i10L | January 3, 2020 |
| Z-1327-2019 | Class II | Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Us | December 3, 2018 |
| Z-1326-2019 | Class II | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: Th | December 3, 2018 |
| Z-1325-2019 | Class II | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: | December 3, 2018 |
| Z-0970-2019 | Class II | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ab | December 3, 2018 |
| Z-2256-2018 | Class II | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgica | March 30, 2018 |
| Z-0643-2018 | Class II | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These | February 13, 2018 |
| Z-0615-2018 | Class II | Video Cystoscope models ECY-1570 and ECY-1570K | July 13, 2017 |
| Z-3068-2017 | Class II | Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination | May 23, 2017 |
| Z-3067-2017 | Class II | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combinatio | May 23, 2017 |