| EW10-EC02 Endoscopy Support Program (K260567) | Fujifilm Corporation | 2026-08-07 |
| FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (K261880) | Fujifilm Corporation | 2026-07-02 |
| FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T (K253137) | Fujifilm Corporation | 2026-06-16 |
| Synapse Lung Nodule AI (K254075) | Fujifilm Corporation | 2026-05-27 |
| Synapse 3D Base Tools (V7.2) (K254189) | Fujifilm Corporation | 2026-04-30 |
| APERTO Lucent MRI System (K253862) | Fujifilm Corporation | 2026-04-06 |
| FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (K251861) | Fujifilm Corporation | 2026-03-09 |
| FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (K250550) | Fujifilm Corporation | 2026-02-17 |
| Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (K253568) | Fujifilm Corporation | 2026-02-06 |
| FUJIFILM Ultrasonic Endoscope EB-710US (K250863) | Fujifilm Corporation | 2025-12-12 |
| ECHELON Synergy (K251386) | Fujifilm Corporation | 2025-09-17 |
| FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (K244017) | Fujifilm Corporation | 2025-06-13 |
| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K243512) | Fujifilm Corporation | 2025-06-10 |
| FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (K243261) | Fujifilm Corporation | 2025-05-23 |
| Synapse 3D Base Tools (V7.0) (K243762) | Fujifilm Corporation | 2025-05-21 |
| SCENARIA View Phase 5.0 (K250370) | Fujifilm Corporation | 2025-05-20 |
| FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (K243260) | Fujifilm Corporation | 2025-04-11 |
| Over-tube (TR-1108A) (K243091) | Fujifilm Corporation | 2024-11-01 |
| Hood (DH-083ST) (K242779) | Fujifilm Corporation | 2024-10-11 |
| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K240142) | Fujifilm Corporation | 2024-09-04 |
| EW10-EC02 Endoscopy Support Program (K230751) | Fujifilm Corporation | 2023-12-15 |
| FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (K223827) | Fujifilm Corporation | 2023-09-08 |
| Synapse 3D Base Tools v6.6 (K221677) | Fujifilm Corporation | 2022-11-10 |
| FUJIFILM Ultrasonic Endoscope EG-740UT (K221238) | Fujifilm Corporation | 2022-08-19 |
| Endoscope Model EG-580UT and Endoscope Model EG-580UR (K221952) | Fujifilm Corporation | 2022-08-04 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (K214089) | Fujifilm Corporation | 2022-06-03 |
| Aspire Cristalle (K212873) | Fujifilm Corporation | 2022-05-27 |
| Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (K220053) | Fujifilm Corporation | 2022-02-04 |
| FDR Cross (DR-XD 3000) (K212956) | Fujifilm Corporation | 2021-11-08 |
| Balloon BS-3 (K213195) | Fujifilm Corporation | 2021-10-29 |
| Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 (K212296) | Fujifilm Corporation | 2021-08-19 |
| Endoscope Model EI-740D/S (K210162) | Fujifilm Corporation | 2021-04-09 |
| Synapse 3D, Synapse 3D Base Tools v6.1 (K203103) | Fujifilm Corporation | 2021-02-09 |
| FUJIFILM Distal End Cap (K203028) | Fujifilm Corporation | 2020-10-30 |
| FUJIFILM Video Laparoscope (K202130) | Fujifilm Corporation | 2020-08-20 |
| Fujifilm Ultrasonic Processor (K200850) | Fujifilm Corporation | 2020-07-06 |
| FUJIFILM EP-6000 Video Processor (K192286) | Fujifilm Corporation | 2020-05-01 |
| DR-ID 1200SDK System (K200668) | Fujifilm Corporation | 2020-04-10 |
| Video Laparoscope, Video Processor, Light Source (K192918) | Fujifilm Corporation | 2020-02-20 |
| FUJIFILM Distal Cap Models 33-40 (K193123) | Fujifilm Corporation | 2019-12-11 |
| FUJIFILM Endoscope Model EC-760Z-V/L (K192664) | Fujifilm Corporation | 2019-11-20 |
| FDR D-EVO III flat panel detector system (K192932) | Fujifilm Corporation | 2019-11-12 |
| FDR SE Lite (K192440) | Fujifilm Corporation | 2019-11-01 |
| Synapse 3D Blood Flow Analysis (K191544) | Fujifilm Corporation | 2019-10-18 |
| FUJIFILM Duodenoscope Model ED-580XT (K191747) | Fujifilm Corporation | 2019-09-27 |
| FUJIFILM Ultrasonic Endoscope (K183433) | Fujifilm Corporation | 2019-09-05 |
| FUJIFILM Bronchoscope (K183607) | Fujifilm Corporation | 2019-08-23 |
| FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L (K183572) | Fujifilm Corporation | 2019-07-16 |
| Biopsy Positioner (K191495) | Fujifilm Corporation | 2019-07-03 |
| FUJIFILM Double Balloon Endoscope EI580BT (K183032) | Fujifilm Corporation | 2019-06-24 |
| FUJIFILM Endoscope Model EC-760S-V/L (K190649) | Fujifilm Corporation | 2019-05-07 |
| Synapse Enterprise Viewer Version 1.0 (K183248) | Fujifilm Corporation | 2019-04-25 |
| FUJIFILM Video Bronchoscopes (K182253) | Fujifilm Corporation | 2019-04-04 |
| FUJIFILM Endoscope Model EG-740N (K182836) | Fujifilm Corporation | 2019-04-02 |
| FUJIFILM Duodenoscope Model (K181745) | Fujifilm Corporation | 2019-03-28 |
| Synapse PACS (K190232) | Fujifilm Corporation | 2019-03-26 |
| FUJIFILM Endoscope Model EG-530N (K183686) | Fujifilm Corporation | 2019-02-28 |
| FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 (K183683) | Fujifilm Corporation | 2019-02-27 |
| FUJIFILM Ultrasonic Endoscope (K182825) | Fujifilm Corporation | 2019-02-22 |
| FUJIFILM Duodenoscope Model (K182051) | Fujifilm Corporation | 2018-10-02 |
| Synapse 3D Optional Tools (K181773) | Fujifilm Corporation | 2018-09-25 |
| FUJIFILM 600 Series Endoscope EG-600WR v2 (K180341) | Fujifilm Corporation | 2018-08-03 |
| FUJIFILM Ultrasonic Endoscope (K181763) | Fujifilm Corporation | 2018-07-27 |
| FUJIFILM Endoscopic CO2 Regulator GW-100 (K180711) | Fujifilm Corporation | 2018-05-25 |
| FUJIFILM Endoscope Models EC-600HL and EC-600LS (K180405) | Fujifilm Corporation | 2018-03-15 |
| FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (K172916) | Fujifilm Corporation | 2018-03-01 |