37 results
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12ms
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Sources: EU EUDAMED, US FDA
CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks AutoPrep System software 2.4.1 release notes Pub. No. J40135EN issued 2012-03-26 page 2, the document states that a new feature unique to software 2.4.1 allows the used to modify a batch in a new way. The user has additional optional fields in the edit sample information dialog box that allows one to enter expanded sample and patient information. The user can also edit the patient management setting for selected samples if not all samples have the same designation.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·August 21, 2013
CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II, CellSpotter System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is fit for in vitro diagnostic use. In the CellTracks Analyzer II software 2.5.1 release notes Pub. No. J40136EN issued 2012-03-26 page 1, the document states that the edit patient sample information screen now includes a patient information section, a new feature unique to software 2.5.1. This section provides a drop down for patient race and cancer type. There are also separate fields for first and last name for both the physician and patient. There is no mention of the drop down patient ID box on the right side of the user interface which auto-populates previous sample data.
FDA Enforcement
Class II
·Terminated·Veridex, LLC·August 21, 2013
Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products LLC·February 21, 2018
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·June 11, 2014
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·December 11, 2013
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·February 25, 2015
The Hemotherm 400CE 115v, containing power board p/n 39945
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·November 30, 2016
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013
Hemotherm CE, model 400CE, Heater-Cooling Device
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·April 26, 2017
Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·January 29, 2014
Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014
Composix" LP with Echo PS" 6 x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
FDA Enforcement
Class II
·Terminated·Davol, Inc., Subs. C. R. Bard, Inc.·June 11, 2014