Focalyx Technologies
United Statesfrom the FDA registration address FDA FEI 3016567400
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
- Registry: GUDID
Company details
- FDA FEI number
- 3016567400
- Address
- 2140 W 68th St Ste 406, Hialeah, FL, 33016
- Website
- www.focalyxtechnologies.com
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 23 Dec 2025 Z-1243-2026 Class II Ongoing Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Frequently asked questions
How many devices does Focalyx Technologies have in the registry?
The registry currently lists 1 device for Focalyx Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Focalyx Technologies's devices?
Among its 1 most recently registered device, Focalyx Technologies has devices listed in FDA GUDID (1 device).
What risk classes do Focalyx Technologies's devices fall under?
Among its 1 most recently registered device, the classes recorded for Focalyx Technologies's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Focalyx Technologies?
FDA recall records list 1 recall initiated by Focalyx Technologies, the most recent initiated on 2025-12-23. 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 Focalyx Technologies in the registry?
The most recently registered devices listed for Focalyx Technologies include Focalyx Fusion 1.7.