FDA.reportPublic FDA data

HEINE USA, LTD.

Matched from indexed company URL: HEI, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10544431000110810HEINE USA, LTD.1Y2026-01-0110 Innovation Way DOVER NH US 03820
20858383000204964HEIDELBERG ENGINEERING U.S. Coprorate Office1Y2026-01-0110 Forge Pkwy Franklin MA US 02038
80106176062HEINZ KURZ GMBH MEDIZINTECHNIK1N2026-01-01TUEBINGER STRASSE 3 DUSSLINGEN Baden-Wurttemberg DE D-72144
80437623002807157HEIDELBERG ENGINEERING GMBH1N2026-01-01Max-Jarecki-Str. 8 HEIDELBERG Baden-Wurttemberg DE 69115
10003790391000379039HEINE OPTOTECHNIK GMBH & CO. KG.1N2026-01-01DORNIERSTR. 6 GILCHING Bavaria DE D-82205
30071411643007141164HEITCO, INC.1N2026-01-011273 Lear Industrial Pkwy Avon OH US 44011
30161704963016170496HEIFENG ZHIZAO(SHENZHEN)TECHNOLOGY CO.,LTD1N2026-01-01Room 1205, Building 1, Vanke Xingchen Building Xinqiao Street, Bao an District shenzhen Guangdong CN 518000
00HEILONGJIANG BUCHANG MEDICAL EQUIPMENT CO., LTD5N2020-04-25floor 3-4, building 6, no.10, 12th big road, hanan, nangang dist Harbin Heilongjiang CN 150000
00HEILONGJIANG XINDA ENTERPRISE GROUP CO., LTD.5N2020-04-25No.9, Dalian North Road, Centralized District of Haping Road, Ha Harbin Heilongjiang CN 150060
10311281031128HEIDELBERG MEDICAL, INC.1N2020-04-25110 Sweetgum Ln. Mailing Address P.O. Box 529 Mineral Bluff GA US 30559
30071411643007141164HEITCO, INC.1N2020-04-251273 Lear Industrial Pkwy Avon OH US 44011
30086045313008604531Heidi Perlman Humphries1N2020-04-252180 SW 71st Terrace Davie FL US 33317
30107337923004295778HEINEMANN AMERICAS, INC1Y2020-04-25550 Biltmore Way Ste 700 Coral Gables FL US 33134
30166483883016648388HEIWEI USA LLC1Y2020-04-255 Penn Plaza 19th Floor New York NY US 10001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
401261069169899K992839SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSEETB1999-09-16
401262013379776K991324TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)KHJ1999-05-18
401261339491689K990923TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010ETB1999-03-31
401261707154232K973226TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)ETD1997-11-04
401261625269226K972585AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGENETA1997-08-04
401261151032754K972492BELL PROSTHESIS (PARTIAL)ETB1997-08-04
444071810259646K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)HLI1997-07-29
444072045231380K944261RETINA ANGIOGRAPHHLI1994-11-14
444071318143969K943956RETINA TOMOGRAPH AND FLOWMETERHLI1994-11-14
444071454145229K943955RETINA FLOWMETERHLI1994-11-14
444072069766919K912891HEIDELBERG RETINA TOMOGRAPHHLI1991-09-27
444071493459568K241163SPECTRALIS with Flex ModuleOBO2024-10-11
444071974026845K240924AnterionOBO2024-12-13
444071499261025K240221SPECTRALIS HRA+OCT and variantsOBO2024-07-01
444071543044949K230897AnterionOBO2023-10-11
444072069960956K223557SPECTRALIS HRA+OCT and variantsOBO2023-10-20
444071278869060K211817AnterionOBO2021-11-05
444071824685225K192391Spectralis HRA+OCT and VariantsOBO2019-09-26
444071785473903K182569Spectralis HRA+OCT and variants with High Magnification ModuleOBO2018-10-18
444071707432326K181594Spectralis HRA+OCT and variants with OCT Angiography ModuleOBO2018-09-13
444071094616950K173648Spectralis HRA + OCT and variantsOBO2018-08-30
444071356358211K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorOBO2017-11-01
444071484715856K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorOBO2016-05-06
126681233345713K142837HEINE SIGMA 250 & HEINE SIGMA 250 M2HLJ2015-01-29
126681821099619K142486HEINE BETA 200, HEINE BETA 200 S, HEINE K 180HLJ2015-05-18
126682053223264K131959HEINE MINI 3000(R) OPHTHALMOSCOPEHLJ2014-03-07
401261257270223K130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISETB2013-12-02
126681430903913K123587HEINE MINI 3000 LED OPHTHALMOSCOPEHLJ2013-03-22
126681537746502K123316HEINE OMEGA 500HLI2013-02-26
444071129854162K121993SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCTOBO2012-10-25
444071433627526K113129SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)OBO2011-11-08
401261839721470K112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISETB2013-02-08
126682040272981K101892HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-DXQ2010-08-27
444071845473927K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAOBO2010-10-01
1213281530223978K093145SPECTRA SERIES BREAST PUMPHGX2010-08-13
401261916161870K071150TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIREETD2007-12-12
444071836442814K063191HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCTOBO2006-10-31
444071502733819K052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)MXK2006-01-13
444071518194268K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)MXK2004-10-13
401261331658393K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMETA2004-10-01
401261237548923K021479CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861ETB2002-05-21
401261104269040K013573CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257ETB2001-11-09
401261575888188K011115KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010MML2001-05-02
401261984469713K010442KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652ETB2001-03-08
401261858883045K002221KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170ETB2000-08-09
401261100264838K001123KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111MML2000-04-21
401261330940893K000127KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10MML2000-04-12
2507981206689879
126681218127903
920711304396787
1451314119920
920711398811881
920711537839606
2350111614961053
126681678944160
1213281776360324
920711951359445
2497112049039874
126681041495757
3259531044565571
126681062343802
126681081376620
126681099823639
126681143027843
126681171869934
2350111181648148
126681197124221
401261213489937
126681214520081
126681265733955
126681330216145
401261378932054
126681387505681
401261403770842
126681494606157
126681508964057
401261523768612
126681533532769
126681553670765
126681553732303
126681554924926
401261604401337
126681658394619
126681668102355
401261692570963
3259531702454304
126681753504413
401261762643451
2350111773472750
126681801817926
3259531812126172
3259531925240082
2350111925307363

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBO162024-12-13
ETB92013-12-02
HLI62013-02-26
HLJ42015-05-18
MML32001-05-02
ETD22007-12-12
MXK22006-01-13
ETA22004-10-01
DXQ12010-08-27
HGX12010-08-13
KHJ11999-05-18

NDC#

Heilen

Heilen

Galium Aparine, Agnus Castus, Apis Mellifica, Capsicum Annuum, Chelidonium Majus, Taraxacum Officinale, Urtica Dioica, Xanthoxylum Fraxineum, Fucus Vesiculosus, Kali Phosphoricum, Magnesia Phosphorica, Natrum Phosphoricum, Sarsaparilla (smilax Regelii), Ubi...

PMN#

Anterion

2024-12-13

Heidelberg Engineering GmbH

Anterion

2023-10-11

Heidelberg Engineering GmbH

Anterion

2021-11-05

Heidelberg Engineering GmbH

59 records. Showing 1-40. Next

Applications#

216940

HEILONGJIANG ZBD PHARMACEUTICAL CO LTD