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Hologic, Inc

50 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3 recall (Z-2167-2026)Hologic, Inc2026-05-12
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS recall (Z-2168-2026)Hologic, Inc2026-05-12
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Mon recall (Z-1949-2026)Hologic, Inc2026-04-24
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 P recall (Z-1586-2026)Hologic, Inc.2026-03-19
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Z-1314-2026)Hologic, Inc2026-02-06
ThinPrep CytoLyt Solution. Buffered Cell Wash Solution. recall (Z-1093-2026)Hologic, Inc2026-01-15
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number recall (Z-1170-2025)Hologic, Inc2025-02-13
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Spe recall (Z-1095-2025)Hologic, Inc.2025-02-04
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge recall (Z-0907-2025)Hologic, Inc.2025-01-14
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 recall (Z-0694-2025)Hologic, Inc.2024-12-20
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical inst recall (Z-0669-2025)Hologic, Inc2024-12-11
BioZorb Marker. Radiographic soft tissue marker. recall (Z-0328-2025)Hologic, Inc2024-11-26
Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1 recall (Z-3248-2024)Hologic Inc2024-09-25
Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, recall (Z-2373-2024)Hologic Inc2024-07-16
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites recall (Z-1733-2024)Hologic, Inc2024-05-03
Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Am recall (Z-1371-2024)Hologic, Inc.2024-03-22
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid test recall (Z-0782-2024)Hologic, Inc.2024-01-23
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from so recall (Z-2035-2023)Hologic, Inc2023-06-29
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D S recall (Z-1144-2023)Hologic, Inc.2023-02-21
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization recall (Z-1858-2022)Hologic, Inc2022-09-30
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnost recall (Z-0877-2022)Hologic, Inc2022-04-06
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, recall (Z-1343-2020)Hologic, Inc.2020-02-18
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 M recall (Z-0655-2017)Hologic, Inc2016-11-22
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. recall (Z-2869-2016)Hologic, Inc2016-09-21
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB recall (Z-2765-2016)Hologic, Inc2016-09-08
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB recall (Z-2766-2016)Hologic, Inc2016-09-08
ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collec recall (Z-2239-2016)Hologic, Inc2016-07-19
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SE recall (Z-1700-2014)Hologic, Inc.2014-06-03
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images recall (Z-1701-2014)Hologic, Inc.2014-06-03
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model recall (Z-1094-2014)Hologic, Inc2014-02-26
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The S recall (Z-2301-2013)Hologic, Inc.2013-09-30
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm recall (Z-1326-2013)Hologic, Inc.2013-05-17
Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a M recall (Z-1327-2013)Hologic, Inc.2013-05-17
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The devi recall (Z-2452-2012)Hologic, Inc.2012-09-25
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The d recall (Z-2453-2012)Hologic, Inc.2012-09-25
Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography recall (Z-1370-2012)Hologic, Inc.2012-04-05
Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate The Officemate, FSIII and FSII recall (Z-3015-2011)Hologic, Inc.2011-08-12
Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, recall (Z-2285-2010)Hologic, Inc.2010-08-26
ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece (part num recall (Z-1160-2010)Hologic, Inc.2010-03-18
Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. In recall (Z-1725-2009)Hologic, Inc.2009-08-25
Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Ind recall (Z-1726-2009)Hologic, Inc.2009-08-25
Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated f recall (Z-1727-2009)Hologic, Inc.2009-08-25
Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for recall (Z-1728-2009)Hologic, Inc.2009-08-25
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers recall (Z-0449-2009)Hologic, Inc.2008-12-29
ATEC Breast Biopsy and Excision System 12 gauge, 20 centimeter handpiece, sterile, Hologic recall (Z-0275-2009)Hologic, Inc.2008-11-07
Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indic recall (Z-2184-2008)Hologic, Inc.2008-09-17
Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicat recall (Z-2185-2008)Hologic, Inc.2008-09-17
Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicate recall (Z-2186-2008)Hologic, Inc.2008-09-17
Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indica recall (Z-2187-2008)Hologic, Inc.2008-09-17
Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated recall (Z-2188-1991)Hologic, Inc.2008-09-17

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Every clearance here is in the API, with alerts when new ones post.