Iskra Medical, D.O.O.
Slovenia(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Iskra Medical Green Irf Prestige Ref K083590
FDA establishments
- Iskra Medical D O O Podnart Radovljica · SI FEI 3007766590
What Iskra Medical, D.O.O. makes
Iskra Medical produces the ISKRA MEDICAL GREEN IRF PRESTIGE, a medical device designed for infrared imaging, likely used in diagnostic or therapeutic procedures requiring thermal visualization.
The device falls under Class II regulation and is listed via the FDA’s 510(k) pathway. Iskra Medical is based in the United States.
Frequently asked questions
How many devices does Iskra Medical, D.O.O. have in the registry?
The registry currently lists 1 device for Iskra Medical, D.O.O.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iskra Medical, D.O.O.'s devices?
Among its 1 most recently registered device, Iskra Medical, D.O.O. has devices listed in FDA 510(k) (1 device).
What risk classes do Iskra Medical, D.O.O.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Iskra Medical, D.O.O.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iskra Medical, D.O.O. in the registry?
The most recently registered devices listed for Iskra Medical, D.O.O. include ISKRA MEDICAL GREEN IRF PRESTIGE.
Which FDA establishments are linked to Iskra Medical, D.O.O.?
1 FDA establishment is linked to Iskra Medical, D.O.O. in the registry; they are listed on the company page.