Hologic, Inc.
Hologic, Inc. holds FDA 510(k) medical device clearances, first cleared 1987, most recent 2026, with 48 FDA device recalls on record.
Top product codes for Hologic, Inc.
FDA recalls by Hologic, Inc.
10 most recent of 48- Z-2167-2026 — SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.
- Z-2168-2026 — 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
- Z-1949-2026 — Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
- Z-1586-2026 — Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
- Z-1314-2026 — Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Z-1093-2026 — ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- Z-1170-2025 — Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
- Z-1095-2025 — The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
- Z-0907-2025 — Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
- Z-0694-2025 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hologic, Inc.
1–100 of 118- K254090 — I-View®
- K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
- K253634 — CoolSeal Generator® (CSL-200-90)
- K251993 — Panther Fusion GI Expanded Bacterial Assay
- K243341 — Genius AI Detection 2.0
- K243396 — Aptima SARS-CoV-2 Assay
- K243935 — Aptima CMV Quant Assay
- K243345 — Aptima BV Assay; Aptima CV/TV Assay
- K242465 — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
- K240886 — Fluent Pro Fluid Management System (FLT-200) +4 more
- K233352 — Aptima HCV Quant Dx Assay
- K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- DEN210035 — Genius Digital Diagnostics System with the Genius Cervical AI algorithm
- K231329 — Aptima Neisseria gonorrhoeae Assay
- K230451 — Aptima® Chlamydia trachomatis Assay
- K231316 — Aptima Trichomonas vaginalis Assay
- K230096 — Genius AI Detection 2.0 with CC-MLO Correlation
- K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- K231017 — Panther Fusion AdV/hMPV/RV Assay
- K221449 — Genius AI Detection 2.0
- K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
- K201019 — Genius AI Detection
- K202294 — Affirm Contrast Biopsy
- K200866 — Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
- K200436 — Aptima 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 kit
- K191281 — Omni Hysteroscope, Omni Lok cervical seal
- K190694 — Unifi Workspace v1.0.0
- K190452 — Aptima BV Assay
- K190515 — Aptima Combo 2 Assay (Panther System)
- K190472 — Aptima CV/TV Assay
- K182052 — Omni Instrument Tray
- DEN180047 — Aptima Mycoplasma genitalium Assay
- K182727 — Trident HD Specimen Radiography System
- K182006 — Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
- K181974 — MyoSure XL Tissue Removal Device for Fluent
- K180825 — Fluent Fluid Management System
- K180681 — Aptima Combo 2 Assay (Panther System)
- K173901 — MyoSure MANUAL Tissue Removal Device
- K180233 — Eviva Stereotactic Guided Breast Biopsy System
- K172629 — Panther Fusion AdV/hMPV/RV Assay
- K172282 — Panther Fusion Paraflu Assay
- K163623 — Quantra
- K171963 — Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
- K172566 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay
- K163052 — Brevera Biopsy System with Corlumina Imaging Technology
- K153486 — Affirm Prone Biopsy System
- K153223 — ProParaFlu+ Assay
- K153219 — ProFlu+ Assay
- K152723 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K150169 — Sertera Biopsy Device
- K142029 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K142037 — QUANTRA
- K140960 — PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K132316 — MULTIVIEW
- K131581 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
- K131736 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
- K130277 — SINGLE ENERGY (SE) FEMUR EXAMS
- K121280 — MYOSURE INTRUMENT TRAY
- K123873 — CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
- K123530 — MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
- K120947 — THS INSTRUMENT TRAY
- K122563 — MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
- K122498 — MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
- K121868 — MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
- K120472 — QUANTRA
- K120388 — INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- K120593 — MYOSURE CONTROL UNIT
- K113356 — HOLOGIC VISCERAL FAT SOFTWARE
- K111508 — TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
- K100943 — INVADER FACTOR II
- K100980 — INVADER FACTOR V
- K100987 — INVADER MTHFR 677
- K100496 — INVADER MTHFR 1298
- K103265 — NHANES WHOLE BODY DXA REFERENCE DATABASE
- K103385 — SECURVIEW DX DIAGNOSTIC WORKSTATION
- K103512 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
- K102768 — SECRMARK BIOPSY SITE MARKING SYSTEM
- K100692 — DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K092405 — MAMMOSITE MULTI LUMEN
- K091378 — MAMMOSITE II RADIATION THERAPY SYSTEM
- K091368 — R2 DIGITALNOW HD(DIGITALNOW HD)
- K082483 — QUANTRA
- K080711 — 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
- K081179 — MAMMOSITE CAVITY EVALUATION DEVICE
- K072847 — APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
- K043617 — IMAGECHECKER CT CAD SOFTWARE SYSTEM
- K062107 — SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
- K061561 — HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
- K060111 — IVA (MXA II SOFTWARE OPTION)
- K051025 — FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
- K042480 — INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
- K041266 — PEDIATRIC REFERENCE DATABASE
- K041555 — SECURVIEW DX SOFTCOPY WORKSTATION
- K040884 — LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K033224 — HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
- K032546 — HOLOGIC DR IMAGEPRO
- K023398 — HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
- K002711 — HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
- K992775 — OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
Data sourced from openFDA. This site is unofficial and independent of the FDA.