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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 19 of 19 Results
510(K) Number: K013642
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AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mec... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanic... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assis... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically con... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or ass... 1 06/13/2016 Carefusion 211 Inc dba Carefusion
Product Name: AVEA® Ventilator. All Models. The affected devices are cleared under K073069 pm 1/2... 1 09/27/2013 Carefusion 211 Inc dba Carefusion
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous re... 1 01/11/2012 Carefusion 211 Inc
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