Data / Medical devices / Croatia
Medical device makers in Croatia: 3 FDA-registered establishments
3 establishments in Croatia are registered with the FDA to make medical devices for the US market, listing 5 device types. 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- CroatiaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | 1 |
| Massager, Powered Inflatable Tube | IRP | 1 |
| Joint, Ankle, External Brace | ITW | 1 |
| Pack, Hot Or Cold, Water Circulating | ILO | 1 |
| Electrode, Cutaneous | GXY | 1 |
Makers in Croatia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Pamel D.O.O. | Zagreb Zagreb, Grad, Croatia | 1 | 1 | 0 | 0 | api.fda.gov |
| Zamar Medical Doo | Brtonigla Istarska Zupanija, Croatia | 3 | 1 | 0 | 0 | api.fda.gov |
| Advanced Textiles Lab D.O.O. | Strigova Medimurska Zupanija, Croatia | 1 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.