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Carl Zeiss Meditec, Inc.

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K243878 CLARUS (700)QER2025-04-17 View
510(k) K233933 CIRRUS™ HD-OCT Model 6000OBO2024-05-17 View
510(k) K230350 VISULAS yagHQF2023-09-22 View
510(k) K231075 Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI2023-06-20 View
510(k) K222200 CIRRUS HD-OCTOBO2023-04-13 View
510(k) K191194 CLARUSQER2019-06-25 View
510(k) K181534 CIRRUS HD-OCTOBO2019-02-15 View
510(k) K181444 CLARUSQER2019-01-10 View
510(k) K182318 Retina WorkplaceNFJ2018-10-24 View
510(k) K173371 VisuMax Femtosecond LaserHNO2018-04-13 View
510(k) K161194 PLEX Elite 9000 SS-OCTOBO2016-10-26 View
510(k) K130549 INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATORJAD2013-06-26 View
510(k) K121653 INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORSJAD2012-12-27 View
510(k) K112184 CIRRUS PHOTOOBO2012-06-18 View
510(k) K111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASESOBO2012-01-19 View
510(k) K093213 GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESHPT2010-03-12 View
510(k) K093521 GDXPROMYC2009-11-25 View
510(k) K082016 GDX VCC WITH ECC SOFTWAREMYC2009-08-10 View
510(k) K083291 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000OBO2009-05-05 View
510(k) K090439 FORUMNFJ2009-03-25 View
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