Tangent Endoscopy, LLC
Country not established FDA establishment FEI 3041659934
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Catalogue
- GUDID
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller Ref K251170
510(k) 510(k)
Company details
- FDA FEI number
- 3041659934
- Address
- 2140 S Dupont Hwy, Camden, DE, 19934
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 1
2026
- 23 Mar 2026 Z-2209-2026 Class II Ongoing Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Frequently asked questions
How many devices does TANGENT ENDOSCOPY, LLC have in the registry?
The registry currently lists 2 devices for TANGENT ENDOSCOPY, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list TANGENT ENDOSCOPY, LLC's devices?
Among its 2 most recently registered devices, TANGENT ENDOSCOPY, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do TANGENT ENDOSCOPY, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for TANGENT ENDOSCOPY, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for TANGENT ENDOSCOPY, LLC?
FDA recall records list 1 recall initiated by TANGENT ENDOSCOPY, LLC, the most recent initiated on 2026-03-23. 1 of them is 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 TANGENT ENDOSCOPY, LLC in the registry?
The most recently registered devices listed for TANGENT ENDOSCOPY, LLC include Tangent Digital catheter tng-4002-ind and Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller.