Medagent, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Medagent, Inc. makes
Medagent, Inc. manufactures monopolar forceps and associated cables, designed for surgical procedures requiring precise tissue manipulation or coagulation.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Bissinger Monopolar Forceps and Cables Ref K143662
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medagent, Inc., initiated on 2023-12-21. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. 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 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 21 Dec 2023 Z-1184-2024 Class II Ongoing Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
Frequently asked questions
How many devices does Medagent, Inc. have in the registry?
The registry currently lists 1 device for Medagent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medagent, Inc.'s devices?
Among its 1 most recently registered device, Medagent, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Medagent, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medagent, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medagent, Inc.?
FDA recall records list 1 recall initiated by Medagent, Inc., the most recent initiated on 21 Dec 2023. 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 Medagent, Inc. in the registry?
The most recently registered devices listed for Medagent, Inc. include Bissinger Monopolar Forceps and Cables.