HOLOGIC, INC.

Entity profile compiled from public source records

Public Record Profile Registrations: 12 510(k) filings: 0 Recalls: 1

Known Identifiers & Locations

FEI Numbers 1000120743, 1221855, 2024800, 3005496266, 3005875675, 3006330030, 3007200016, 3010377594, 3012644426, 3013649990, 3014090621, 3030927217
Owner Operator Numbers 9007676
Locations Covered Berlin, DE; Blankenfelde-Mahlow Brandenburg, DE; Cambridge Cambridgeshire, GB; El Coyol Alajuela, CR; LONDONDERRY, NH, US; LOUISVILLE, CO, US; Marlborough, MA, US; Newark, DE, US; REDWOOD CITY, CA, US; SAN DIEGO, CA, US

Registered Establishments (12)

Registration # Establishment Name Location Establishment Type(s) Action
1221855 Hologic, Inc. LONDONDERRY, NH, US Manufacture Medical Device View Details
1222780 HOLOGIC, INC. Marlborough, MA, US Complaint File Establishment per 21 CFR 820.198 View Details
2024800 Hologic, Inc. SAN DIEGO, CA, US Manufacture Device in the United States for Export Only View Details
3005496266 HOLOGIC, INC. Newark, DE, US Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device View Details
3005875675 GYNESONICS, INC. REDWOOD CITY, CA, US Manufacture Medical Device View Details
3006330030 Hologic, Inc. Marlborough, MA, US Manufacture Medical Device View Details
3007200016 Hologic Surgical Products Costa Rica, S.R.L. El Coyol Alajuela, CR Manufacture Medical Device View Details
3010377594 BOLDER SURGICAL, LLC LOUISVILLE, CO, US Develop Specifications But Do Not Manufacture At This Facility View Details
3012644426 ENDOMAGNETICS LTD Cambridge Cambridgeshire, GB Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3013649990 HEALTH BEACONS, INC. Marlborough, MA, US Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details
3014090621 SOMATEX Medical Technologies GmbH Blankenfelde-Mahlow Brandenburg, DE Export Device to the United States But Perform No Other Operation on Device View Details
3030927217 SOMATEX Medical Technologies GmbH Berlin, DE Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall # Product Description Initiation Date Status Action
Z-0027-2018 Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use Reason: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. 2017-09-15 Terminated View Details

Profile Disclaimer

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