Focal Therapeutics
Country not established
- Devices
- 18
What Focal Therapeutics makes
Focal Therapeutics manufactures radiofrequency ablation markers, including the BioZorb SP Marker, BioZorb LP Marker, BioZorb Marker GOLD, and the TISSUE MARKER. These devices are designed for use in medical procedures to identify and locate ablation zones in tissue, aiding in the treatment of conditions such as tumors or arrhythmias.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States.
Catalogue
Search and filter all 18 devicesFrequently asked questions
How many devices does Focal Therapeutics have in the registry?
The registry currently lists 18 devices for Focal Therapeutics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Focal Therapeutics's devices?
Among its 18 most recently registered devices, Focal Therapeutics has devices listed in FDA 510(k) (5 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Focal Therapeutics's devices fall under?
Among its 18 most recently registered devices, the classes recorded for Focal Therapeutics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Focal Therapeutics in the registry?
The most recently registered devices listed for Focal Therapeutics include BioZorb LP Marker F0221, BioZorb Marker F0303, BioZorb Marker F0203 and PERL Localization Device, 16Ga x 11.5cm Needle R10.