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Hologic, Inc.

6156 adverse events · 310 clearances · 97 recalls · 70 inspections · 2 compliance actions · aggregated across 5 source records

Scorecard
Events per device across the 1,154-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.82 ▼

941 in the last 12 months

Higher volume than 98% of companies with 10+ devices

Recalls per device

0.012 ▼

14 in the last 12 months

Higher volume than 99% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
1,154 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
NovaSure SureSound2013MNB15420045501126884
BioZorbF0202NEU15420045513983773
Myosure Reach Tissue Removal Device10-401FCHIH15420045504530629
EVIVA_0913-20EVIVA_0913-20KNW15420045504974573
Brevera Breast Biopsy SystemBREVDISP09KNW15420045512863560
Fluent Fluid Management SystemFLT-112SHIG HIH15420045507401537
3Dimensions3DM-SYS-STDOTE15420045510524348
NovaSureV5MNB15420045514300339
BioZorbF0203NEU15420045513990329
Brevera Breast Biopsy SystemBREV100KNW15420045507517302
NovaSureNS2013USMNB15420045501119280
MyoSure Tissue Removal Device30-401LITEHIH15420045505070252
Brevera Breast Biopsy SystemBREVDRVKNW15420045507760227
Acessa ProVu System7300HFG15420045515246191
Myosure XL for Fluent Device50-601XLHIH15420045507654182
Selenia DimensionsSDM-SYS-6000-3DOTE15420045510760177
NovaSure SureSound2007MNB15420045501133168
NovaSureV5MNB15420045514294152
NovaSureNS2000USMNB15420045501140148
BioZorbF0304NEU15420045514010146
ATEC 0912-20ATEC 0912-20KNW15420045504868136
BioZorbF0303NEU15420045514003123
BioZorbF0221NEU15420045514027113
ATEC SAPPHIRE 100ATEC SAPPHIRE 100KNW15420045504028104
Selenia DimensionsSDM-SYS-9000-3DOTE15420045510784104
MyoSure Tissue Removal Device50-501XLHIH15420045505094103
ATEC SAPPHIREATEC SAPPHIREKNW1542004550429597
MYOSURE HYSTEROSCOPY SET40-250HIH2542004551032396
BioZorbF0231NEU1542004551403493
EVIVA 0913-12TEVIVA 0913-12TKNW1542004550533988
Showing 1–30 of 1,154Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
DateTypeActionFirm
2024-12-18WLWarning LetterHologic, Inc
2024-12-18WLWarning LetterHologic, Inc
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3010377594BOLDER SURGICAL, LLCLOUISVILLE, CO, USNAI
3012644426ENDOMAGNETICS LTDCambridge Cambridgeshire, GB—
3005875675GYNESONICS, INC.REDWOOD CITY, CA, USNAI
3013649990HEALTH BEACONS, INC.Marlborough, MA, USVAI
1000120743HOLOGIC, INC.Marlborough, MA, USOAI
3005496266HOLOGIC, INC.Newark, DE, US—
3007200016Hologic Surgical Products Costa Rica, S.R.L.El Coyol Alajuela, CRVAI
3006330030Hologic, Inc.Marlborough, MA, USVAI
2024800Hologic, Inc.SAN DIEGO, CA, USNAI
1221855Hologic, Inc.LONDONDERRY, NH, USNAI
3014090621SOMATEX Medical Technologies GmbHBlankenfelde-Mahlow Brandenburg, DE—
3030927217SOMATEX Medical Technologies GmbHBerlin, DE—