Home › Device types › ODG
Endoscopic Ultrasound System, Gastroenterology-Urology
FDA product code ODG · Class 2 · Gastroenterology, Urology
212
Registered devices
16,330
Adverse events
10
Recalls
44
510(k) clearances
Devices with this code
BALLOON SHEATH — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EUS ENDOSCOPIC ULTRASOUND CENTER — OLYMPUS MEDICAL SYSTEMS CORP.iNod™ — BOSTON SCIENTIFIC CORPORATIONTrident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB) — Micro-Tech (Nanjing) Co., Ltd.LIGHTGUIDE CAP — OLYMPUS MEDICAL SYSTEMS CORP.EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.BALLOON3 — OLYMPUS MEDICAL SYSTEMS CORP.SWQ SOFTWARE OPTION — OLYMPUS MEDICAL SYSTEMS CORP.Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) — Micro-Tech (Nanjing) Co., Ltd.PENTAX — HOYA CORPORATIONEndoSound® Ultrasound Disposable Kit (UDK-T) 5008 — Endosound, Inc.SonoScape — SONOSCAPE MEDICAL CORP.Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) — Micro-Tech (Nanjing) Co., Ltd.EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) — Micro-Tech (Nanjing) Co., Ltd.FUJIFILM — FUJIFILM CORPORATIONPENTAX — HOYA CORPORATIONCLEANING ADAPTER FOR INSTRUMENT CHANNELPORT — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONULTRASONIC CABLE A — OLYMPUS MEDICAL SYSTEMS CORP.BALLOON — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONPENTAX Medical — HOYA CORPORATIONBalloon Applicator — OLYMPUS MEDICAL SYSTEMS CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin |
| 2020-10-16 | Olympus Corporation of the Americas | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causin |
| 2018-03-12 | Micro-Tech (Nanjing) Co., Ltd. | The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute |
| 2018-03-12 | Micro-Tech (Nanjing) Co., Ltd. | The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute |
| 2017-05-23 | Pentax of America Inc | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, th |
| 2017-05-23 | Pentax of America Inc | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, th |
| 2016-04-06 | Pentax Medical Company | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with t |
| 2015-08-21 | Olympus Corporation of the Americas | Insufficient information for specific cleaning accessories used for the cleaning and reprocessing of the GF-UCT180 ultrasound endoscope |
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