Skip to content

Medical device manufacturer

Hologic, Inc.

Hologic, Inc. holds 116 FDA 510(k) clearances across 33 product codes. Median elapsed review time is 87 days. openFDA lists 63 recall records naming the company. FDA publishes it under 10 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
116
Product codes
33
Median review
87 days
Recall records
63

How does FDA spell Hologic, Inc.?

FDA publishes this company under 10 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
HOLOGIC, INC.device/registrationlistingnormalised
Hologicdevice/510knormalised
Hologic Incdevice/recallnormalised
Hologic Incdevice/enforcementnormalised
Hologic, Incdevice/enforcementnormalised
Hologic, Incdevice/recallnormalised
Hologic, Inc.device/510knormalised
Hologic, Inc.device/registrationlistingnormalised

Showing 8 of 10.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Hologic, Inc. file in?

33 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
KGIDensitometer, Bone29113 days
HIHHysteroscope (And Accessories)1352 days
LLZSystem, Image Processing, Radiological1360 days
IZHSystem, X-Ray, Mammographic638 days
OCCRespiratory Virus Panel Nucleic Acid Assay System425 days
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer4141 days
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections446 days
JAQSystem, Applicator, Radionuclide, Remote-Controlled321 days
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories3210 days
KNWInstrument, Biopsy3148 days
PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System379 days
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents387 days
HIGInsufflator, Hysteroscopic2115 days
JAASystem, X-Ray, Fluoroscopic, Image-Intensified221 days
LSLDna-Reagents, Neisseria290 days
MWPCabinet, X-Ray System279 days
OMMTest 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr2399 days
OOUParainfluenza Multiplex Nucleic Acid Assay233 days
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System290 days
GEIElectrosurgical, Cutting & Coagulation & Accessories1210 days
KPRSystem, X-Ray, Stationary170 days
MKZDna Probe, Nucleic Acid Amplification, Chlamydia1268 days
MUEFull Field Digital, System, X-Ray, Mammographic143 days
MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus1299 days
NEUMarker, Radiographic, Implantable169 days

Showing the 25 they file in most, of 33.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Hologic, Inc. had a recall?

openFDA lists 63 recall records naming this company across its whole history, of which 6 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2167-2026Class IIOpen, ClassifiedMUE

    Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

  • Z-2168-2026Class IIOpen, ClassifiedOTE

    Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

  • Z-1949-2026Class IIOpen, ClassifiedQYV

    It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.

  • Z-1586-2026Class IIOpen, ClassifiedOYB

    Due to product exhibiting potential to generate either invalid or false negative results.

  • Z-1314-2026Class IIOpen, ClassifiedKNW

    Presence of particulates in affected devices that can be deposited into breast tissue during use.

Showing the 5 most recently initiated of 63.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Hologic, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K253634CoolSeal Generator® (CSL-200-90)GEI210
K251993Panther Fusion GI Expanded Bacterial AssayPCH90
K251868Panther Fusion GI Bacterial AssayPCH99
K243341Genius AI Detection 2.0QDQ279
K243396Aptima SARS-CoV-2 AssayQQX105
K243935Aptima CMV Quant AssayPAB28
K243345Aptima BV Assay; Aptima CV/TV AssayPQA28
K242465Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF87
K240886Fluent 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)HIG115
K233352Aptima HCV Quant Dx AssayMZP299

Source: openFDA device/510k · retrieved

Where is Hologic, Inc. registered?

FDA lists 5 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Hologic, Inc. files next

Get an email when this company clears a new device, or when anything is recalled in a product code you follow.

Start watching with DeviceSignal

Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.