BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HOLOGIC, INC.

    Reg #: 1222780 · FEI: 1000120743 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    91
    Establishment Types
    4
    Classifications
    39

    Registration Details

    Registration Name
    HOLOGIC, INC.
    Registration Number
    1222780
    FEI Number
    1000120743
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    250 Campus Dr
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K081179
    PMA Number
    P010013

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    System, Applicator, Radionuclide, Remote-Controlled JAQ
    Hysteroscope (And Accessories) HIH
    Marker, Radiographic, Implantable NEU
    System, X-Ray, Film Marking, Radiographic JAC
    Insufflator, Hysteroscopic HIG
    Tape And Bandage, Adhesive KGX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Processor, Cervical Cytology Slide, Automated MKQ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Apparatus, Melting Point, Paraffin IDT
    Tray, Surgical LRP
    Instrument, Biopsy KNW
    Device, Thermal Ablation, Endometrial MNB
    Slides, Microscope KEW
    Needle, Hypodermic, Single Lumen FMI
    Guide, Needle, Surgical GDF
    Hysteroscope Accessories NWW
    Minor Surgical Procedures Tray PYB
    Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm QYV
    Unit, Cryosurgical, Accessories GEH
    Preservative, Cytological LEA
    Guide, Surgical, Instrument FZX
    Probe, Uptake, Nuclear IZD
    Wound Dressing Kit MCY
    Stain, Papanicolau HZJ
    Slide Stainer, Automated KPA
    Instrument, Manual, Surgical, General Use MDM
    System, Applicator, Radionuclide, Manual IWJ
    Source, Brachytherapy, Radionuclide KXK
    Filters, Cell Collection, Tissue Processing KET
    Reader, Cervical Cytology Slide, Automated MNM
    Sound, Uterine HHM
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Coagulator, Laparoscopic, Unipolar (And Accessories) HFG
    Tracking, Soft Tissue, Intraoperative OEW
    Transducer, Ultrasonic, Diagnostic ITX
    Cytocentrifuge IFB
    Seal, Cervical, Mechanical, Unpowered QHZ

    Proprietary Names

    MammoSite Cavity Evaluation Device MyoSure Reach BioZorb SP Marker Marker Wire Kit Fluent Pro Fluid Management System FirstCyte Contour Cover CoolSeal Mini; CoolSeal Generator Omni instrument tray BioZorb LP Marker Tumark Professional SecurMark Cellient MammoSite Office Accessory Kit Brevera Breast Biopsy System with Corlumina Imaging Technology NovaSure RF Controller NovaSure Device (Handpiece) NovaSure EndometrialAblation System ThinPrep Slides ThinPrep Arcless Slides FirstCyte Tapered&UltraSlim Dilator Sertera Introducer Set Celero Introducer Set MyoSure MyoSure Single Use Seals MyoSure Rod Lens Hysteroscope Trimark Mammosite accessory trays Genius Digital Diagnostics System with the Genius Cervical AI algorithm Eviva Stereotactic Breast Biopsy Device Eviva Adapters Myosure XL Hysteroscope Sanarus V2 Treatment System MammoSite ML ConturaFlex MLB Catheter without Introducer ConturaFlex MLB Catheter with Introducer Contura Introducer and Split Sheath Contura MLB catheter with Introducer Contura MLB Catheter without Introducer Contura Accessory kit Fluent PreservCyt and CytoLyt Sizer Set TruNode Gamma Probe System MammoSite RTS system 5-6 balloon MyoSure XL TRD for Fluent MammoSite Patient Care Kit ThinPrep Imaging System Stain Omni CoolSeal Trinity Contura Lumen Market Set, Single White Lumen marker, Single Black Lumen Marker, Compass Stainer MammoSite Radiation Therapy System MammoSite 4-6 balloon GliaSite Radiation Therapy System Contura Cavity Maintenance Catheter with Introducer Celero ThinPrep filters Tumark Professional Q ATEC Console Tissue Filter Eviva ATEC Needle Guides Introducer Localization Set (ILS) ATEC Adapters MammoSite 4-5 balloon & Afterloader Tissue Removal Device SureSound INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM Tumark Flex Acessa ProVu System THS SterilizationTray ThinPrep Imaging System ThnPrep Integrated Imager Review Scope Manual + Contura MLB Catheter with Introducer ThinPrep 5000 Processor ThinPrep Gynecological Slides ThinPrep Gynecological Filters ThinPrep 2000 Slide Processor ThinPrep Gynecological Preservative (PreservCyt) ThinPrep® CERV(TM) PreservCyt® Solution ThinPrep® CERV(TM) Gynecological Filters ThinPrep Genesis Processor ThinPrep Processor BioZorb Marker CoolSeal Reveal Instrument, Biopsy Sertera Biopsy Device Omni Lok Myosure Instrument Tray

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only Manufacture Medical Device