Kiscomedica S.A.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Kiscomedica S.A. makes
Kiscomedica S.A. manufactures the L-VARLOCK, a medical device designed for securing intravenous lines and vascular access ports to the patient’s body, reducing dislodgement risk during use.
The L-VARLOCK is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
L-Varlock Ref K080537
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Kiscomedica S.A., initiated on 2017-01-11. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. 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 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 11 Jan 2017 Z-1461-2017 Class II Terminated Firm received a complaint of the tip holder breaking during use.
Frequently asked questions
How many devices does Kiscomedica S.A. have in the registry?
The registry currently lists 1 device for Kiscomedica S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kiscomedica S.A.'s devices?
Among its 1 most recently registered device, Kiscomedica S.A. has devices listed in FDA 510(k) (1 device).
What risk classes do Kiscomedica S.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Kiscomedica S.A.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Kiscomedica S.A.?
FDA recall records list 1 recall initiated by Kiscomedica S.A., the most recent initiated on 11 Jan 2017. 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 Kiscomedica S.A. in the registry?
The most recently registered devices listed for Kiscomedica S.A. include L-VARLOCK.