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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 19 Results
510(K) Number: K013642
 
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VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) 2 05/14/2008 Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) 2 05/14/2008 Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version) 2 05/14/2008 Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) 2 05/14/2008 Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version) 2 05/14/2008 Viasys Respiratory Care, Inc.dba Bird Products
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous re... 1 01/11/2012 Carefusion 211 Inc
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
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
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