Medical Device Manufacturer · US , San Diego , CA

Carl Zeiss Meditec, Inc. - FDA 510(k) Cleared Devices

29 submissions · 29 cleared · Since 1993
29
Total
29
Cleared
0
Denied

FDA 510(k) cleared devices by Carl Zeiss Meditec, Inc. Ophthalmic

25 devices
1-25 of 25
Cleared Apr 17, 2025
CLARUS (700)
K243878 · QER
Ophthalmic · 120d
Cleared May 17, 2024
CIRRUS™ HD-OCT Model 6000
K233933 · OBO
Ophthalmic · 155d
Cleared Sep 22, 2023
VISULAS yag
K230350 · HQF
Ophthalmic · 225d
Cleared Apr 13, 2023
CIRRUS HD-OCT
K222200 · OBO
Ophthalmic · 262d
Cleared Jun 25, 2019
CLARUS
K191194 · QER
Ophthalmic · 53d
Cleared Feb 15, 2019
CIRRUS HD-OCT
K181534 · OBO
Ophthalmic · 249d
Cleared Jan 10, 2019
CLARUS
K181444 · QER
Ophthalmic · 223d
Cleared Oct 24, 2018
Retina Workplace
K182318 · NFJ
Ophthalmic · 58d
Cleared Apr 13, 2018
VisuMax Femtosecond Laser
K173371 · HNO
Ophthalmic · 168d
Cleared Oct 26, 2016
PLEX Elite 9000 SS-OCT
K161194 · OBO
Ophthalmic · 182d
Cleared Sep 01, 2015
CIRRUS HD-OCT
K150977 · OBO
Ophthalmic · 141d
Cleared Jul 10, 2015
IOLMaster700
K143275 · HJO
Ophthalmic · 238d
Cleared Jun 18, 2012
CIRRUS PHOTO
K112184 · OBO
Ophthalmic · 326d
Cleared Jan 19, 2012
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and...
K111157 · OBO
Ophthalmic · 269d
Cleared Mar 12, 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · HPT
Ophthalmic · 150d
Cleared Nov 25, 2009
GDXPRO
K093521 · MYC
Ophthalmic · 12d
Cleared Aug 10, 2009
GDX VCC WITH ECC SOFTWARE
K082016 · MYC
Ophthalmic · 391d
Cleared May 05, 2009
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES,...
K083291 · OBO
Ophthalmic · 179d
Cleared Mar 25, 2009
FORUM
K090439 · NFJ
Ophthalmic · 33d
Cleared Jan 26, 2007
CIRRUS HD-OCT, MODEL 4000
K063378 · HLI
Ophthalmic · 79d
Cleared Sep 30, 2005
VISANTE OCT
K051789 · HLI
Ophthalmic · 91d
Cleared May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433 · HLI
Ophthalmic · 80d
Cleared Jun 26, 1995
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
K951132 · HLI
Ophthalmic · 105d
Cleared Jul 18, 1994
NERVE FIBER ANALYZER
K941705 · HLI
Ophthalmic · 103d
Cleared Mar 26, 1993
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742 · HLI
Ophthalmic · 242d
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