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Data / Medical devices / Germany / CARL ZEISS MEDITEC AG (Munich)

CARL ZEISS MEDITEC AG (Munich): FDA-registered device maker in Muenchen Bavaria, Germany, 8 510(k) clearances

CARL ZEISS MEDITEC AG (Munich) is registered with the FDA (registration 3009746052) in Muenchen Bavaria, Germany. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 15, 2022. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch CARL ZEISS MEDITEC AG (Munich)
FDA registration number
3009746052
Address
Kistlerhof Strasse 75, Muenchen Bavaria, Germany, 81379
Owner or operator
Carl Zeiss Meditec AG (Jena) (9053564)
Roles
Manufacturer, Specification developer
First device listed
December 29, 2003
Registered through
2026
Brand names listed
CALLISTO EYE, CALLISTO eye, CALLISTO eye Panel PC, FORUM, FORUM Archive, FORUM Archive and Viewer, FORUM Assist match, FORUM GLAUCOMA WORKPLACE and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Manufactureraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Manufactureraccessdata.fda.gov
Device, Communications, Images, OphthalmicNFG1Manufactureraccessdata.fda.gov
Marker, OcularHMR1Manufactureraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Manufactureraccessdata.fda.gov
Microscope, SurgicalEPT1Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Specification developeraccessdata.fda.gov
System, Image Management, OphthalmicNFJ2Manufactureraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 15, 2022K213527FORUMNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
October 24, 2018K182318Retina WorkplaceNFJSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
June 21, 2017K170638Retina WorkplaceNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
October 3, 2014K141297FORUM GLAUCOMA WORKPLACENFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
September 9, 2014K141068ZEISS CATARACT SUITE MARKERLESSHJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
July 23, 2013K130648FORUM GLAUCOMA WORKPLACENFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
March 5, 2013K123464CALLISTO EYENFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
March 25, 2009K090439FORUMNFJSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov

Compare with other makers

Updated August 15, 2022. 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.