79 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.
FDA Recall
Terminated
·Hologic, Inc.·Product code KNW·August 11, 2010
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
FDA Recall
Terminated
·Hologic, Inc·Product code JQW·June 27, 2017
Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·September 24, 2008
Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
FDA Recall
Terminated
·Hologic, Inc.·Product code JAA·April 25, 2013
Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.
FDA Recall
Terminated
·Hologic, Inc.·Product code IZH·May 13, 2014
Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.
FDA Recall
Terminated
·Hologic, Inc.·Product code JAA·April 25, 2013
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
FDA Recall
Terminated
·Hologic, Inc.·Product code MUE·May 13, 2014
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography
FDA Recall
Terminated
·Hologic, Inc.·Product code MUE·September 6, 2013
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Recall
Terminated
·Hologic, Inc·Product code NUA·March 31, 2016
Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·June 27, 2008
Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·June 27, 2008
Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·June 27, 2008
Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·June 27, 2008
Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.
FDA Recall
Terminated
·Hologic, Inc.·Product code KGI·June 27, 2008
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Enforcement
Class II
·Terminated·Hologic, Inc·October 25, 2017
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Enforcement
Class II
·Terminated·Hologic, Inc·May 4, 2016
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Enforcement
Class II
·Terminated·Hologic, Inc.·February 28, 2018
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA Enforcement
Class II
·Terminated·Hologic, Inc.·February 28, 2018
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Recall
Terminated
·Hologic, Inc.·Product code LKV·November 29, 2017
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA Recall
Terminated
·Hologic, Inc.·Product code LKV·November 29, 2017