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CareFusion 203, Inc.

5 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on p recall (Z-2593-2014)CareFusion 203, Inc.2014-09-19
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or recall (Z-2006-2012)CareFusion 203, Inc.2012-07-16
CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch recall (Z-0074-2012)CareFusion 203, Inc.2011-10-26
Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits recall (Z-2205-2010)CareFusion 203, Inc.2010-08-10
Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapo recall (Z-0857-2010)CareFusion 203, Inc.2010-02-25

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Every clearance here is in the API, with alerts when new ones post.