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Data / Medical devices / Tomography, Optical Coherence / Germany

FDA-registered makers of Tomography, Optical Coherence in Germany: 6 establishments

6 establishments in Germany are registered with the FDA to make Tomography, Optical Coherence (product code OBO). 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
Tomography, Optical Coherence
Product code
OBO
Country
Germany

Makers of Tomography, Optical Coherence in Germany

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Heidelberg Engineering GMBHHEIDELBERG Baden-Wurttemberg, GermanyManufacturer4September 11, 2026020api.fda.gov
Carl Zeiss Meditec AG (jena)JENA Thuringia, GermanySpecification developer2March 19, 2014000api.fda.gov
Carl Zeiss Meditec AG (Jena)Jena Thuringia, GermanyManufacturer2March 19, 2014000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer1November 18, 2014000api.fda.gov
CARL ZEISS MEDITEC AG (Munich)Muenchen Bavaria, GermanyManufacturer0000api.fda.gov
Oculus Optikgerate GMBHWETZLAR Hesse, 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.