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SynCardia Systems Inc.

2 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product recall (Z-2731-2015)SynCardia Systems Inc.2015-09-17
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a co recall (Z-0620-2013)SynCardia Systems Inc.2012-12-28

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