10 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EVOLU Non Contact Infrared Ear/Forehead Thermometer
FDA UDI
FORANS SIA·04751037660038·
EVOLU Intelligent Blood Pressure Monitor
FDA UDI
FORANS SIA·04751037660045·
ARCHITECT ANTI-HCV REAGENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INT'L, LTD·Product code MZO·May 13, 2009
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·November 14, 2014
ARCHITECT ANTI-HCV REAGENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INT'L, LTD·Product code MZO·May 6, 2009
AXSYM HCV 3.0
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MZO·May 1, 2009
AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·March 22, 2017
AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·October 5, 2018
AIA-900 Analyzer, Product code 022930, 022930R
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·October 5, 2018
e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code KPS·June 26, 2015