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Data / Medical devices / System, Image Management, Ophthalmic / Germany

FDA-registered makers of System, Image Management, Ophthalmic in Germany: 5 establishments

5 establishments in Germany are registered with the FDA to make System, Image Management, Ophthalmic (product code NFJ). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

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Device
System, Image Management, Ophthalmic
Product code
NFJ
Country
Germany

Makers of System, Image Management, Ophthalmic in Germany

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Carl Zeiss Meditec AG (jena)JENA Thuringia, GermanyManufacturer, Specification developer8July 17, 2026000api.fda.gov
CARL ZEISS MEDITEC AG (Munich)Muenchen Bavaria, GermanyManufacturer7August 15, 2022000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyExporter to the US, Manufacturer2March 5, 2013000api.fda.gov
Carl Zeiss Meditec AG (Jena)Jena Thuringia, GermanyManufacturer1May 21, 2015010api.fda.gov
Heidelberg Engineering GMBHHEIDELBERG Baden-Wurttemberg, GermanyManufacturer0000api.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.