FDA.reportPublic FDA data

CARL ZEISS MEDITEC INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29186302918630CARL ZEISS MEDITEC INC1Y2026-01-015300 Central Parkway DUBLIN CA US 94568

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
212731451370841K961171HUMPHREY OCT SCANNERHLI1996-06-21
212731414613106K954167HUMPHREY FIELD ANALYZER (HFA II)HPT1995-11-24
212731363252903K941705NERVE FIBER ANALYZERHLI1994-07-18
212732069793788K802029OBJECTIVE REFRACTORHKO1980-11-12
212732007963376K243878CLARUS (700)QER2025-04-17
212731385940553K233933CIRRUS™ HD-OCT Model 6000OBO2024-05-17
212731310785660K222200CIRRUS HD-OCTOBO2023-04-13
212731801680079K191194CLARUSQER2019-06-25
212731637451308K181534CIRRUS HD-OCTOBO2019-02-15
212731793819555K181444CLARUSQER2019-01-10
212731755948908K180306NexyHKI2018-06-08
212731078606678K161194PLEX Elite 9000 SS-OCTOBO2016-10-26
212731260634926K150977CIRRUS HD-OCTOBO2015-09-01
212731334893215K141922IRIS INTELLIGENT RETINAL IMAGING SYSTEMNFJ2015-02-27
212731307988698K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASESOBO2012-01-19
212732046592607K093521GDXPROMYC2009-11-25
212731119090238K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESHPT2010-03-12
212731760765231K083291CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000OBO2009-05-05
212731511973426K082016GDX VCC WITH ECC SOFTWAREMYC2009-08-10
212731243670393K063378CIRRUS HD-OCT, MODEL 4000HLI2007-01-26
212731467919837K051789VISANTE OCTHLI2005-09-30
212731658029696K033123STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASEHLI2004-04-20
212731947422184K030433STRATUSOCT WITH RNFL NORMATIVE DATABASEHLI2003-05-01
212731331595422
212731474708252
212731841973435
212731443897359
212731451552129
212731644577052
212731757622200
212731771683732
212732053981373

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBO72024-05-17
HLI62007-01-26
QER32025-04-17
HPT22010-03-12
MYC22009-11-25
HKI12018-06-08
NFJ12015-02-27
HKO11980-11-12

PMN#