9,582 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UPATH SOFTWARE - SUPPORT
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC·Product code NQN·August 7, 2020
FOCAL POINT
FDA Adverse Event
Other
·TRIPATH IMAGING, INC.·Product code NQN·February 9, 2006
UPATH ENTERPRISE SOFTWARE, IVD
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS INC·Product code NQN·March 28, 2023
CONFIRM ER
FDA Adverse Event
Injury
·VENTANA MEDICAL SYSTEMS INC·Product code NQN·May 25, 2017
BENCHMARK XT
FDA Adverse Event
Malfunction
·VENTANA MEDICAL SYSTEMS, INC·Product code NQN·May 31, 2016
QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NQN·November 6, 2008
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code NQN·November 23, 2020
Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Systems, Inc., Tucson, AZ 85755
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NQN·June 26, 2007
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
FDA Recall
Terminated
·Leica Biosystems Richmond Inc.·Product code NQN·May 6, 2016
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
FDA classification
FDA Class 2
·Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Amvex Vacuum Regulator
FDA UDI
OHIO MEDICAL, LLC·00628101501693·VR-N2 series, VacReg, Neo Cont 2Mode 100mmHg, ...
MICROTECH
FDA UDI
Starkey Laboratories, Inc.·00842318124104·
AUDIGY GROUP
FDA UDI
Starkey Laboratories, Inc.·00842318130273·
AUDIBEL
FDA UDI
Starkey Laboratories, Inc.·00842318124791·
STARKEY
FDA UDI
Starkey Laboratories, Inc.·00842318129956·
AUDIGY GROUP
FDA UDI
Starkey Laboratories, Inc.·00842318130266·
MICROTECH
FDA UDI
Starkey Laboratories, Inc.·00842318130198·
AUDIBEL
FDA UDI
Starkey Laboratories, Inc.·00842318130020·
MICROTECH
FDA UDI
Starkey Laboratories, Inc.·00842318130181·
NUEAR
FDA UDI
Starkey Laboratories, Inc.·00842318130112·