FDA.reportPublic FDA data

CARL ZEISS MEDITEC INC

Matched from indexed company URL: Carl Zeiss Meditec

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29186302918630CARL ZEISS MEDITEC INC1Y2026-01-015300 Central Parkway DUBLIN CA US 94568
96150303001362763Carl Zeiss Meditec AG (Jena)1N2026-01-01Carl-Zeiss-Promenade 10 Jena Thuringia DE 07745
30101262683010126268Carl Zeiss Meditec Production, LLC.1N2026-01-011040 S VINTAGE AVE BLDG A Ontario CA US 91761
30121230333012123033Carl Zeiss Meditec Cataract Technology Inc1N2026-01-018740 Technology Way Reno NV US 89521
30155340773015534077Carl Zeiss Meditec Digital Innovations Inc1N2026-01-017348 Honeysuckle Dr Temple TX US 76503
30327346593032734659Carl Zeiss Meditec (Suzhou) Co., Ltd.1N2026-01-014F, No.26 Wu Sheng Road, SIP Suzhou Jiangsu CN 215126
30383568643038356864CARL ZEISS MEDITEC AG (JENA)1N2026-01-01Goeschwitzer Strasse 51-52 JENA Thuringia DE 07745
30413967583041396758CARL ZEISS MEDITEC USA, INC.1Y2026-01-015300 Central Pkwy Dublin CA US 94568

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
212771278745495P990048ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTERMVF2000-04-12
212771165888886P150040VISUMAX FEMTOSECOND LASEROTL2016-09-13
1792121031669153P100016EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOLHQL2010-10-19
212771456944168P060004MEL 80 EXCIMER LASER SYSTEMLZS2006-08-11
3462331456944168P060004MEL 80 EXCIMER LASER SYSTEMLZS2006-08-11
212771893340077K993357IOLMASTERHJO2000-03-20
3462331893340077K993357IOLMASTERHJO2000-03-20
212731451370841K961171HUMPHREY OCT SCANNERHLI1996-06-21
212731414613106K954167HUMPHREY FIELD ANALYZER (HFA II)HPT1995-11-24
212731363252903K941705NERVE FIBER ANALYZERHLI1994-07-18
212772009032712K926452ZEISS VISULAS YAG II LASERGEX1993-11-22
3462332009032712K926452ZEISS VISULAS YAG II LASERGEX1993-11-22
212771791180431K925641ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATRHJO1993-09-09
3462331791180431K925641ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATRHJO1993-09-09
212771963514240K923341ZEISS VISULAS ARGON LASERGEX1992-10-28
3462331963514240K923341ZEISS VISULAS ARGON LASERGEX1992-10-28
212771914239609K862004ZEISS 30 SL-LHJO1986-06-17
3462331914239609K862004ZEISS 30 SL-LHJO1986-06-17
212771782286528K853891INDIRECT OPHTHALMOSCOPEHLJ1985-10-04
3462331782286528K853891INDIRECT OPHTHALMOSCOPEHLJ1985-10-04
212732069793788K802029OBJECTIVE REFRACTORHKO1980-11-12
212732007963376K243878CLARUS (700)QER2025-04-17
2267081457791533K243395MICOR 700 with Auto I/AHQC2025-08-08
212731385940553K233933CIRRUS™ HD-OCT Model 6000OBO2024-05-17
212771916348937K233911VISULAS combiHQF2024-09-06
212771843541780K232944CALLISTO eyeNFJ2023-12-21
212771523913071K232051VISULAS greenHQF2023-10-24
212771183618289K231676CALLISTO eyeNFJ2023-08-28
212771883653271K230350VISULAS yagHQF2023-09-22
2267081044858502K222236miCOR System Lens Fragmentation SystemHQC2022-08-24
212731310785660K222200CIRRUS HD-OCTOBO2023-04-13
2267081184735412K214028MICOR Lens Fragmentation SystemHQC2022-09-09
2267081120004045K200584xPORT 304 (miCOR) System Lens Fragmentation SystemHQC2020-07-31
212731801680079K191194CLARUSQER2019-06-25
212771389769160K181682VISULAS greenHQF2019-03-06
212731637451308K181534CIRRUS HD-OCTOBO2019-02-15
212731793819555K181444CLARUSQER2019-01-10
212771615296815K180839AT 030HKY2018-06-07
212731755948908K180306NexyHKI2018-06-08
212771727524073K173771IOLMaster 700HJO2018-08-24
3404341036152434K171007Fluorescence ModeNBL2018-05-03
212771615509801K162684SL 220HJO2017-05-31
3462331615509801K162684SL 220HJO2017-05-31
212731078606678K161194PLEX Elite 9000 SS-OCTOBO2016-10-26
212731260634926K150977CIRRUS HD-OCTOBO2015-09-01
212771814960026K150467Retina WorkplaceNFJ2015-05-21
3462331814960026K150467Retina WorkplaceNFJ2015-05-21
212771814707448K143275IOLMaster700HJO2015-07-10
3462331814707448K143275IOLMaster700HJO2015-07-10
212731334893215K141922IRIS INTELLIGENT RETINAL IMAGING SYSTEMNFJ2015-02-27
212771867786287K141297FORUM GLAUCOMA WORKPLACENFJ2014-10-03
212771980312481K141068ZEISS CATARACT SUITE MARKERLESSHJO2014-09-09
3462331980312481K141068ZEISS CATARACT SUITE MARKERLESSHJO2014-09-09
212771073702677K133476SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTIONHJO2014-02-12
3462331073702677K133476SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTIONHJO2014-02-12
212771644577052K133217CIRRUS PHOTOOBO2014-03-19
3462331644577052K133217CIRRUS PHOTOOBO2014-03-19
212771103261104K130648FORUM GLAUCOMA WORKPLACENFJ2013-07-23
1792121760837085K123888Z CARTRIDGE IOL DELIVERY SYSTEMMSS2013-04-15
212771617096173K122938FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCHNFJ2012-11-02
212771089044418K122418IOLMASTER 500HJO2013-04-12
3462331089044418K122418IOLMASTER 500HJO2013-04-12
212771757622200K112184CIRRUS PHOTOOBO2012-06-18
3462331757622200K112184CIRRUS PHOTOOBO2012-06-18
212731307988698K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASESOBO2012-01-19
212771776485693K103056VISULAS TRION LASER SYSTEM WITH THE VITE OPTIONHQF2011-02-01
3462331776485693K103056VISULAS TRION LASER SYSTEM WITH THE VITE OPTIONHQF2011-02-01
212771287891482K101182IOLMASTER 500HJO2010-11-03
3462331287891482K101182IOLMASTER 500HJO2010-11-03
212771854048518K100253VISUMAX LASER KERATOMEHQF2010-07-08
212771932791687K100035MODEL VISULAS 532S LASER WITH THE VITE OPTIONGEX2010-03-17
3462331932791687K100035MODEL VISULAS 532S LASER WITH THE VITE OPTIONGEX2010-03-17
212732046592607K093521GDXPROMYC2009-11-25
212731119090238K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESHPT2010-03-12
212771633751810K090439FORUMNFJ2009-03-25
212731760765231K083291CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000OBO2009-05-05
212731511973426K082016GDX VCC WITH ECC SOFTWAREMYC2009-08-10
212771621150782K072514VISULAS TRIONGEX2007-09-21
3462331621150782K072514VISULAS TRIONGEX2007-09-21
212731243670393K063378CIRRUS HD-OCT, MODEL 4000HLI2007-01-26
212771588500579K062314HORUS LASER KERATOMEGEX2006-12-22
3462331588500579K062314HORUS LASER KERATOMEGEX2006-12-22
212771963229360K052268VISUCAM PRO NMHKI2005-11-02
3462331963229360K052268VISUCAM PRO NMHKI2005-11-02
212731467919837K051789VISANTE OCTHLI2005-09-30
212771127607823K043222VISCUCAM C DIGITAL CAMERAHKI2005-02-14
3462331127607823K043222VISCUCAM C DIGITAL CAMERAHKI2005-02-14
212771421508398K042139VISULAS YAG IIIGEX2004-09-09
3462331421508398K042139VISULAS YAG IIIGEX2004-09-09
212731658029696K033123STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASEHLI2004-04-20
212771482672085K032799NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZERHKX2004-01-20
3462331482672085K032799NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZERHKX2004-01-20
212731947422184K030433STRATUSOCT WITH RNFL NORMATIVE DATABASEHLI2003-05-01
212771147162430K013402VISULAS 532SGEX2001-11-14
3462331147162430K013402VISULAS 532SGEX2001-11-14
212771277625164K011877FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEMHKI2001-09-26
3462331277625164K011877FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEMHKI2001-09-26
212771104511031K003885VISULAS YAG IIGEX2001-02-22
3462331104511031K003885VISULAS YAG IIGEX2001-02-22
212731331595422
212771451552129
212731474708252
2267081532988927
212731841973435
3404341035329063
212771076222936
3462331076222936
212731443897359
3404341449259738
212731451552129
3462331451552129
212771453903552
3462331453903552
212771540647669

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HJO212018-08-24
GEX172010-03-17
OBO112024-05-17
NFJ92023-12-21
HQF72024-09-06
HKI72018-06-08
HLI62007-01-26
HQC42025-08-08
QER32025-04-17
LZS 32006-08-11
OTL22016-09-13
HPT22010-03-12
MYC22009-11-25
HKX22004-01-20
HLJ21985-10-04
HKY12018-06-07
NBL12018-05-03
MSS12013-04-15
HQL12010-10-19
MVF12000-04-12
HKO11980-11-12

PMA#

88 records. Showing 1-40. Next

PMN#

77 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next