Visionsense Ltd.
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Visionsense Ltd. is a medical device manufacturer, with 104 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I) and 4 FDA recalls as of 12 Nov 2026.
- Devices
- 104
- FDA recalls
- 43 ongoing
Registry facts
- Registries
- FDA GUDID 91
- FDA 510(k) 13
- EUDAMED 1
- Device classes
- FDA Class II 99
- FDA Class I 5
- FDA recalls
- Identifiers
- DUNS 532199478
At a glance
Market reach
- United States
- FDA recalls
What Visionsense Ltd. makes
VisionSense Ltd. manufactures endoscopic video camera systems, including models with infrared capabilities, alongside endoscopic video image processing and light source systems. Their portfolio also includes general-purpose surgical microscopes, fibreoptic light cables, endoscopic device remote controls, light source adaptors, and manually-adjusted surgical instrument assist arm systems. These products are designed for use in surgical and diagnostic procedures requiring high-resolution imaging and precise lighting.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These devices are listed under the FDA’s 510(k) and Unique Device Identification (UDI) systems, ensuring compliance with US regulatory requirements.
Catalogue
Search and filter all 104 devicesShowing 1-50 of 104
Company details
- DUNS number
- 532199478
- Phone
- +1(508)261-8000
FDA recalls
FDA recall records list 4 recalls initiated by VISIONSENSE LTD., the earliest on 2011-03-21 and the most recent on 2022-10-17. By recorded status: 3 ongoing and 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 3
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 17 Oct 2022 Z-0280-2023 Class II Ongoing Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
- 17 Oct 2022 Z-0281-2023 Class II Ongoing XXX
- 17 Oct 2022 Z-0282-2023 Class II Ongoing Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
2011
- 21 Mar 2011 Z-1192-2012 Unclassified (pre-2012) Terminated A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally, during in-process visual inspection of the metal and glass shaft window sub-assembly from a specific batch that was received from the supplier it was noted that the window at the tip of the scope was not seated properly. It was determined that the wi
Frequently asked questions
How many devices does VISIONSENSE LTD. have in the registry?
The registry currently lists 104 devices for VISIONSENSE LTD.. Devices recorded under merged duplicate company entries are counted once.
Which registries list VISIONSENSE LTD.'s devices?
Among its 50 most recently registered devices, VISIONSENSE LTD. has devices listed in FDA GUDID (50 devices).
What risk classes do VISIONSENSE LTD.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for VISIONSENSE LTD.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for VISIONSENSE LTD.?
FDA recall records list 4 recalls initiated by VISIONSENSE LTD., the most recent initiated on 17 Oct 2022. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from VISIONSENSE LTD. in the registry?
The most recently registered devices listed for VISIONSENSE LTD. include VS3-IR 174-0012, VS3-IR 174-0051, VS3-IR 143-0051 and VS3-NE 153-0007.