Home › Device types › FDF
Colonoscope And Accessories, Flexible/Rigid
FDA product code FDF · Class 2 · Gastroenterology, Urology
727
Registered devices
78,289
Adverse events
25
Recalls
113
510(k) clearances
Devices with this code
PENTAX — HOYA CORPORATIONAer-O-Scope Water Bottle — G.I. VIEW LTDEVIS EXERA lll COLONOVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.DiLumen C1, 103 cm — LUMENDI LLCDEFENDO — MEDIVATORS INC.n.a. — Karl Storz GmbH & Co. KGFLEX — MEDROBOTICS CORPORATIONEVIS EXERA III XENON LIGHT SOURCE — OLYMPUS MEDICAL SYSTEMS CORP.G-EYE Colonoscope — SMART MEDICAL SYSTEMS LTDGripTract-GI Endoscopic Tissue Manipulator — ACTUATED MEDICAL, INC.Fuse® — ENDOCHOICE, INC.DEFENDO — MEDIVATORS INC.MEDISONO — Medisono, LLCEndoch — Endoch IncLIGHTGUIDE CAP — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX Medical — HOYA CORPORATIONDEFENDO Air/Water and Suction Valves — MEDIVATORS INC.Aer-O-Scope Workstation — G.I. VIEW LTDPure-Vu — MOTUS GI MEDICAL TECHNOLOGIES LTDDEFENDO Disposable Biopsy Valve — MEDIVATORS INC.G-EYE Colonoscope — SMART MEDICAL SYSTEMS LTDSonoScape — SONOSCAPE MEDICAL CORP.Fuse — ENDOCHOICE, INC.ENDOSCOPE POSITION DETECTING UNIT — OLYMPUS MEDICAL SYSTEMS CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl |
| 2024-01-11 | Olympus Corporation of the Americas | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fl |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-16 | Aizu Olympus Co., Ltd. | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. |
| 2023-10-02 | Olympus Corporation of the Americas | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
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