Home › Device types › FEM
Accessories, Photographic, For Endoscope (Exclude Light Sources)
FDA product code FEM · Class 1 · Gastroenterology, Urology
158
Registered devices
698
Adverse events
5
Recalls
4
510(k) clearances
Devices with this code
ZEOS — SANTA BARBARA IMAGING SYSTEMS, INC.ScopEYE — MediThinQ Co., Ltd.NA — Richard Wolf GmbHLumax™ — Coopersurgical, Inc.Olympus — KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDOlympus — KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDLight Cable, ACMI-Wolf/Dyonics, 1mm — CLARUS MEDICAL, LLCOlympus — KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDPENTAX — HOYA CORPORATIONFUJIFILM — FUJIFILM CORPORATIONFUSION DESIGN — Richard Wolf GmbHARM CLAMP 1 — OLYMPUS MEDICAL SYSTEMS CORP.Olympus — KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFUSION DESIGN — Richard Wolf GmbHAdapter, Wolf/Dyonics — CLARUS MEDICAL, LLCAED 20MM Optical Coupler — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FUSION-DESIGN — Richard Wolf GmbHNA — Richard Wolf GmbHFUSION-DESIGN — Richard Wolf GmbHOlympus — KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDRIWO — Richard Wolf GmbHCONNECTER HOLDER RUBBER — OLYMPUS MEDICAL SYSTEMS CORP.ARM CLAMP 2 — OLYMPUS MEDICAL SYSTEMS CORP.Endocraft LLC — Endocraft, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-21 | Ambu Inc. | Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion ba |
| 2019-06-10 | Olympus Corporation of the Americas | WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds. |
| 2011-10-28 | Olympus America Inc. | Replacement wheels may break off from the base of the cart |
| 2003-10-10 | Smith And Nephew, Inc. Endoscopy Division | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
| 2003-10-10 | Smith And Nephew, Inc. Endoscopy Division | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
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