4 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200.
FDA Recall
Terminated
·Draeger Medical Systems, Inc.·Product code FMT·July 17, 2009
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·October 1, 2003
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
FDA Recall
Terminated
·Critical Diagnostics·Product code OYG·February 28, 2012
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·August 30, 2024