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Data / Medical devices / Computer, Diagnostic, Programmable / Israel

FDA-registered makers of Computer, Diagnostic, Programmable in Israel: 5 establishments

5 establishments in Israel are registered with the FDA to make Computer, Diagnostic, Programmable (product code DQK). 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Computer, Diagnostic, Programmable
Product code
DQK
Country
Israel

Makers of Computer, Diagnostic, Programmable in Israel

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biosense Webster (Israel), Ltd.Yokneam Northern, IsraelManufacturer15February 20, 2026010api.fda.gov
Itamar MedicalCAESAREA Haifa, IsraelManufacturer2December 29, 2022000api.fda.gov
Itamar Medical Ltd. (Alon)Caesarea Haifa, IsraelManufacturer2December 29, 2022000api.fda.gov
Change Healthcare Israel Ltd.HOLON Central, IsraelSpecification developer1March 16, 2012030api.fda.gov
Sanmina- Sci Israel Medical Systems Ltd.Maalot-Tarshiha Northern, IsraelContract manufacturer0000api.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.