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Data / Medical devices / Germany / Carl Zeiss Meditec AG (oberkochen)

Carl Zeiss Meditec AG (oberkochen): FDA-registered device maker in OBERKOCHEN Baden-Wurttemberg, Germany, 23 510(k) clearances

Carl Zeiss Meditec AG (oberkochen) is registered with the FDA (registration 9615010) in OBERKOCHEN Baden-Wurttemberg, Germany. It lists 25 device types. The FDA files 23 510(k) clearances under its listings, the newest dated January 10, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Carl Zeiss Meditec AG (oberkochen)
FDA registration number
9615010
FEI number
3003481798
Address
Rudolf-Eber-Strasse 11, OBERKOCHEN Baden-Wurttemberg, Germany, D-73447
Owner or operator
Carl Zeiss Meditec AG (Jena) (9053564)
Roles
Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 2, 1992
Registered through
2026
Brand names listed
1 Chip HD Camera, ARTEVO 750/850, ARTEVO 800, Asepsis Caps, Asepsis VISULUX, BLUE 400, BLUE 400 S, CALLISTO EYE and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Manufactureraccessdata.fda.gov
Camera, Surgical And AccessoriesKQM1Manufactureraccessdata.fda.gov
Chair And Table, MedicalKMN1Manufactureraccessdata.fda.gov
Colposcope (And Colpomicroscope), ExemptPTZ2Manufactureraccessdata.fda.gov
Confocal Optical ImagingOWN2Manufactureraccessdata.fda.gov
Diagnostic Neurosurgical Microscope FilterQFX2Manufactureraccessdata.fda.gov
Drape, Microscope, OphthalmicHMW2Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufacturer, Specification developeraccessdata.fda.gov
Endoscope, NeurologicalGWG2Manufactureraccessdata.fda.gov
Hook, OphthalmicHNQ1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Repackager or relabeleraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Manufactureraccessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE2Manufactureraccessdata.fda.gov
Marker, OcularHMR1Exporter to the US, Manufactureraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Manufacturer, Specification developeraccessdata.fda.gov
Microscope, SurgicalEPT1Exporter to the US, Manufactureraccessdata.fda.gov
Microscope, Surgical, General & Plastic SurgeryFSO1Manufactureraccessdata.fda.gov
Spectacle, Operating (Loupe), OphthalmicHOH1Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Manufactureraccessdata.fda.gov
System, Image Management, OphthalmicNFJ2Exporter to the US, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, Therapeutic, X-RayJAD2Manufactureraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Manufactureraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Manufactureraccessdata.fda.gov
Unit, PhacofragmentationHQC2Manufactureraccessdata.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
January 10, 2025K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)JADSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
June 28, 2024K240215BLUE 400; BLUE 400 SQFXSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
September 21, 2023K232159QEVO SystemGWGSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
July 31, 2023K230858QUATERA 700HQCSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
June 20, 2023K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZISubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
July 22, 2022K211346BLUE 400QFXSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
April 19, 2022K212241QUATERA 700HQCSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
December 29, 2021K211156CONVIVO In Vivo Pathology SuiteLLZSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
June 15, 2020K193376Visalis V500, Visalis S500HQCSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
October 25, 2018K181116CONVIVOGWGSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
August 18, 2017K170667QEVO System with KINEVO 900GWGSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
July 24, 2017K162991YELLOW 560 Fluorescence ModuleIZIUnknownCarl Zeiss Meditec, AGaccessdata.fda.gov
February 23, 2017K161607VISULUXHJOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
December 15, 2016K162568INTRABEAM 600JADSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
November 18, 2014K141844RESCAN 700, CALLISTO EYEOBOSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
June 26, 2013K130549INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORJADSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
March 5, 2013K123464CALLISTO EYENFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
December 27, 2012K121653INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSJADSubstantially EquivalentCarl Zeiss Meditec, Inc.accessdata.fda.gov
November 2, 2012K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCHNFJSubstantially EquivalentCarl Zeiss Meditec, AGaccessdata.fda.gov
April 13, 2012K110590INTRABEAM NEEDLE APPLICATORJADSubstantially EquivalentCarl Zeiss Surgical GmbHaccessdata.fda.gov
March 3, 2010K100468ZEISS INFRARED 800 WITH FLOW 800 OPTIONIZISubstantially EquivalentCarl Zeiss Surgical GmbHaccessdata.fda.gov
November 24, 2009K090584INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETSJADSubstantially EquivalentCarl Zeiss Surgical GmbHaccessdata.fda.gov
May 23, 2005K051055INTRABEAM SYSTEMJADSubstantially EquivalentCarl Zeiss Surgical GmbHaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 1, 202699239Class IIOngoingZeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.accessdata.fda.gov
March 16, 202289928Class IIOngoingZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.High friction of the slider can cause the device to stick, or not move as intended.accessdata.fda.gov
August 30, 201778082Class IITerminatedCarl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatmentsThe device had an incorrect printed calibration value on the calibration certificate.accessdata.fda.gov

Compare with other makers

Updated July 1, 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.