FDA.reportPublic FDA data

Hologic, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12218551221855Hologic, Inc.1N2026-01-014 Navigator Rd LONDONDERRY NH US 03053
12227801000120743HOLOGIC, INC.1Y2026-01-01250 Campus Dr Marlborough MA US 01752
20248002024800Hologic, Inc.1Y2026-01-0110210 Genetic Center Dr SAN DIEGO CA US 92121
30054962663005496266HOLOGIC, INC.1N2026-01-01600 Technology Drive Newark DE US 19702
30063300303006330030Hologic, Inc.1N2026-01-01445 Simarano Drive Marlborough MA US 01752
12209841220984Hologic, Inc.1N2020-04-2536 APPLE RIDGE RD. DANBURY CT US 06810
29398521000124200Hologic, Inc.1N2020-04-251240 ELKO DRIVE SUNNYVALE CA US 94089

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850346007023CoolSeal™ Generator - Electrosurgical Generator+1(800)442-9892customersupport@hologic.com
00850346007030CoolSeal™ Trinity - Maryland Laparoscopic Sealer/Divider/Dissector, 30 cm+1(800)442-9892customersupport@hologic.com
00850346007047CoolSeal™ Trinity - Maryland Laparoscopic Sealer/Divider/Dissector, 37 cm+1(800)442-9892customersupport@hologic.com
00850346007061CoolSeal™ Trinity - Maryland Laparoscopic Sealer/Divider/Dissector, 44 cm+1(800)442-9892customersupport@hologic.com
00850346007085CoolSeal™ Mini - Maryland Laparoscopic Sealer+1(800)442-9892customersupport@hologic.com
00850346007092CoolSeal™ Reveal - Open Seal, Divider, and Dissector+1(800)442-9892customersupport@hologic.com
15420045515796Envision - The main system level software for the Atlas system. The Atlas system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Atlas (2D or 3D™) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the Atlas system can be used to generate 2D digital mammograms and 3D™ mammograms. Each screening examination may consist of: • A 2D FFDM image set, or • A 2D and 3D™ image set, where the 2D image can be either a FFDM or a 2D image generated from the 3D™ image set The Atlas system may also be used for additional diagnostic workup of the breast.+1(800)442-9892CustomerSupport@hologic.com
15420045515802Envision - License key for optional tomosynthesis software for the Envision system that enables capturing tomosynthesis images with the system.+1(800)442-9892CustomerSupport@hologic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
141202040648580P970058M1000 IMAGECHECKERMYN1998-06-26
3223322040648580P970058M1000 IMAGECHECKERMYN1998-06-26
825461822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
825481822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
825501822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
1471721809426043P940034GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)MWA1995-12-15
825511414778586P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)LKV1995-09-21
825481414778586P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)LKV1995-09-21
1471721414778586P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)LKV1995-09-21
1471721668990975P210029Aptima CMV Quant AssayPAB2022-05-09
1471721172428899P170025Aptima HBV Quant AssayMKT2018-01-23
1471721232477131P160023APTIMA HCV QUANT DX ASSAYMZP2017-02-13
1471721920231708P120007APTIMA HPV 16 18/45 GENOTYPE ASSAYOYB2012-10-12
1471721090241396P100042APTIMA HPV ASSAYOYB2011-10-28
1471721010601805P100033PROGENSA PCA3 ASSAYOYM2012-02-13
1471721787124509P080015CERVISTA HPV 16/18MAQ2009-03-12
825481938260113P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KITMAQ2009-03-12
825461938260113P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KITMAQ2009-03-12
1471721938260113P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KITMAQ2009-03-12
141201819363063P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
3223321819363063P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
1471721182706925P020011VERSANT HCV RNA QUALITATIVE ASSAYMZP2002-11-07
825482016712891P020002THINPREP (R) IMAGING SYSTEMMNM2003-06-06
825462016712891P020002THINPREP (R) IMAGING SYSTEMMNM2003-06-06
141201686514750P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
3223321686514750P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
825461081561366P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMMNB2001-09-28
825481081561366P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMMNB2001-09-28
1471721037575530K974572GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820MDK1998-09-24
1471721126316087K940979GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORRLSL1994-10-31
1471721457486303K924715GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTMDK1994-03-11
1471721725186074K921435ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURELQF1992-07-23
1471721566719290K905762GEN-PROBE LUMINOMETER-LEADER 450JJQ1991-01-23
1471721068600755K904463ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TESTLQF1990-11-13
1471721042140239K904047ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.MDF1990-10-02
1471721119715267K903556ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TESTMDE1990-10-02
1471721424879742K903201ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TESTMDC1990-09-12
1471721835041759K902908ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.MCT1990-08-06
1471721849612737K902213ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.MCS1990-08-06
1471721855430336K901397ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.MCC1990-06-20
825511756165192K900225ROMCHECK SPECIMEN COLLECTION KITLIO1990-02-02
1471721756165192K900225ROMCHECK SPECIMEN COLLECTION KITLIO1990-02-02
1471721294209617K897077ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURELQF1990-08-23
1471721734339521K896859ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TESTMBT1990-02-01
1471721345933894K896493ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TESTLQF1990-04-11
1471721180035892K896492ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TESTLQF1990-04-16
1471721925956558K895583ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.LSL1989-11-14
1471721787985127K894711ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.GTZ1989-11-14
1471721870443865K892216GEN-PROBE PACE SYSTEM URINE SCREENJXA1989-09-15
1471721024872819K870422GEN-PROBE BETA-LACTAMASE TEST KITJTO1987-04-21
1471721350553225K860574GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEMLQG1986-07-03
1471721450475965K851271LEGIONELLA CULTURE CONFIRMATIN KITGRO1985-07-08
1471721672089001K251993Panther Fusion GI Expanded Bacterial AssayPCH2025-09-25
1471721775029324K251868Panther Fusion GI Bacterial AssayPCH2025-09-25
1471721393807055K243935Aptima CMV Quant AssayPAB2025-01-17
1471721388245826K243396Aptima SARS-CoV-2 AssayQQX2025-02-13
1471721600047419K243345Aptima BV Assay; Aptima CV/TV AssayPQA2024-11-25
3223321838593481K243341Genius AI Detection 2.0QDQ2025-07-31
1471721903357787K242465Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF2024-11-15
1471721969145069K241240Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2024-07-18
825461603453877K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)HIG2024-07-25
825481603453877K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)HIG2024-07-25
1471721386497909K233352Aptima HCV Quant Dx AssayMZP2024-07-24
1471721652777373K231329Aptima Neisseria gonorrhoeae AssayLSL2024-01-26
1471721568622140K231316Aptima Trichomonas vaginalis AssayOUY2023-11-06
1471722045271054K231017Panther Fusion AdV/hMPV/RV AssayOCC2023-05-05
825462056770975K231012CoolSeal TrinityGEI2023-11-15
1471721003469928K230451Aptima® Chlamydia trachomatis AssayMKZ2023-11-16
3223321033952506K230096Genius AI Detection 2.0 with CC-MLO CorrelationQDQ2023-05-23
1471721173238648K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2023-05-16
3223321268906682K221449Genius AI Detection 2.0QDQ2022-10-06
825461259920593K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)GEI2021-09-07
825462024439993K203640CoolSeal RevealGEI2021-05-06
3223321095290126K202294Affirm Contrast BiopsyIZH2020-10-05
825461085255110K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20GEI2020-10-06
3223321183317565K201019Genius AI DetectionQDQ2020-11-18
1471721845674297K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)QEP2020-05-17
1471721913217545K200436Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kitQEP2020-03-23
825461290740641K192371BioZorb SP MarkerNEU2019-09-26
825461942002579K191281Omni Hysteroscope, Omni Lok cervical sealHIH2019-08-29
825461444738216K190813CrossBay Cervical Dilator Catheter SystemPON2019-08-23
141201482153036K190694Unifi Workspace v1.0.0LLZ2019-07-11
3223321482153036K190694Unifi Workspace v1.0.0LLZ2019-07-11
825481296470871K190678TempSureGEI2019-07-24
1471721321949227K190515Aptima Combo 2 Assay (Panther System)QEP2019-05-23
1471721629563572K190472Aptima CV/TV AssayPQA2019-05-16
1471721523487084K190452Aptima BV AssayPQA2019-05-23
3223321015348947K183142PathVisionXLMWP2019-03-14
141202019704017K182727Trident HD Specimen Radiography SystemMWP2019-01-10
3223322019704017K182727Trident HD Specimen Radiography SystemMWP2019-01-10
825481952747785K182365TempSure SystemGEI2018-10-24
825461045265839K182052Omni Instrument TrayKCT2019-02-26
825461460346830K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHIH2018-12-06
825462061981158K181974MyoSure XL Tissue Removal Device for FluentHIH2018-08-23
825461267677027K181124Acessa ProVu SystemHFG2018-09-28
825481267677027K181124Acessa ProVu SystemHFG2018-09-28
825481677731182K180825Fluent Fluid Management SystemHIG2018-08-03
825461677731182K180825Fluent Fluid Management SystemHIG2018-08-03
825461014821240K180233Eviva Stereotactic Guided Breast Biopsy SystemKNW2018-04-10
825461604967866K173901MyoSure MANUAL Tissue Removal DeviceHIH2018-05-08
1471721984419248K172629Panther Fusion AdV/hMPV/RV AssayOCC2017-12-04
825461000257084K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2017-09-20
1471721364958247K172282Panther Fusion Paraflu AssayOOU2017-10-23
1471721835677155K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis TubesOCC2017-09-26
825481044636491K171262TempSureGEI2017-09-22
141201775146042K163623QuantraLLZ2017-10-20
3223321775146042K163623QuantraLLZ2017-10-20
825462011353142K163052Brevera Biopsy System with Corlumina Imaging TechnologyKNW2017-03-29
3223322011353142K163052Brevera Biopsy System with Corlumina Imaging TechnologyKNW2017-03-29
1471721724624678K162673Aptima Herpes Simplex Viruses 1 & 2 AssayOQO2017-06-15
141201332125062K161575Affirm Lateral Arm Upright Biopsy AccessoryIZH2016-08-10
3223321332125062K161575Affirm Lateral Arm Upright Biopsy AccessoryIZH2016-08-10
141201017626099K153486Affirm Prone Biopsy SystemIZH2016-04-01
3223321017626099K153486Affirm Prone Biopsy SystemIZH2016-04-01
825461219927638K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2015-11-13
825481219927638K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2015-11-13
825461459820442K152070BioZorb LP MarkerNEU2015-08-26
825461543774113K150169Sertera Biopsy DeviceKNW2015-08-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HIH272019-08-29
IZH212020-10-05
LLZ152019-07-11
NEU132019-09-26
JAQ122009-08-27
GEI92023-11-15
KNW92018-04-10
LSL72024-01-26
MWP72019-03-14
OCC62023-05-05
HIG52024-07-25
MKQ51996-05-20
LQF51992-07-23
QDQ42025-07-31
OUY42023-11-06
QEP42020-05-17
MUE42013-01-29
MAQ42009-03-12
KGI42008-03-28
PCH32025-09-25
PQA32024-11-25
QOF32024-11-15
MZP32024-07-24
MKZ32023-11-16
KCT32019-02-26
OXO32012-04-06
LKV31995-09-21
QYV22024-01-31
HFG22018-09-28
OOU22017-10-23
OYB22012-10-12
OMM22011-05-13
OTE22011-02-11
GEH22008-02-07
IYX22006-09-13
JAA22005-05-13
MNM22003-06-06
MNB22001-09-28
MDK21998-09-24
MYN 21998-06-26

PMA#

200 records. Showing 41-80. Previous Next

PMN#

104 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next