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Syncardia Systems, LLC

85 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
SynCardia Total Artificial Heart (STAH) system (P030011/S096)Syncardia Systems, LLC2025-12-17
Total Artificial Heart (P030011/S093)Syncardia Systems, LLC2025-11-19
Total Artificial Heart (P030011/S081)Syncardia Systems, LLC2025-06-25
Total Artificial Heart (P030011/S092)Syncardia Systems, LLC2024-11-25
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S089)Syncardia Systems, LLC2024-03-04
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S088)Syncardia Systems, LLC2023-11-01
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S087)Syncardia Systems, LLC2023-10-18
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S086)Syncardia Systems, LLC2023-08-09
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S085)Syncardia Systems, LLC2023-08-01
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S064)Syncardia Systems, LLC2023-07-06
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S084)Syncardia Systems, LLC2023-04-12
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S080)Syncardia Systems, LLC2022-11-22
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S082)Syncardia Systems, LLC2022-09-22
SynCardia temporary Total Artificial Heart System (P030011/S079)Syncardia Systems, LLC2020-10-28
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S077)Syncardia Systems, LLC2020-05-01
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S078)Syncardia Systems, LLC2020-03-12
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S070)Syncardia Systems, LLC2020-03-05
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S076)Syncardia Systems, LLC2020-01-22
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S074)Syncardia Systems, LLC2019-11-26
SynCardia temporary Total Artificial Heart (Tah-t) System (P030011/S072)Syncardia Systems, LLC2019-09-19
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S073)Syncardia Systems, LLC2019-08-15
SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System (P030011/S071)Syncardia Systems, LLC2019-07-18
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S069)Syncardia Systems, LLC2019-06-26
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S068)Syncardia Systems, LLC2019-04-17
SynCardia temporary Total Artifical Heart (TAH-t) System (P030011/S067)Syncardia Systems, LLC2019-02-20
Syncardia Temporary Total Artificial Heart (TAH-T) system (P030011/S066)Syncardia Systems, LLC2019-01-09
SynCardia temporaty Total Artificial Heart (TAH-t) System (P030011/S065)Syncardia Systems, LLC2018-12-17
SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System (P030011/S062)Syncardia Systems, LLC2018-07-04
SynCardia temporary Total Artificial Heart (TAH-t) (P030011/S051)Syncardia Systems, LLC2018-05-02
SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System (P030011/S061)Syncardia Systems, LLC2018-04-25
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM (P030011/S060)Syncardia Systems, LLC2018-03-16
SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System (P030011/S057)Syncardia Systems, LLC2017-12-08
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S059)Syncardia Systems, LLC2017-12-07
SynCardia temporary Total Artificial Heart (TAH-T) System (P030011/S050)Syncardia Systems, LLC2017-12-06
SynCardia temporary Total Artificial Heart (TAH-t) System; Freedom Driver System (P030011/S058)Syncardia Systems, LLC2017-12-01
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S056)Syncardia Systems, LLC2017-09-29
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S055)Syncardia Systems, LLC2017-06-09
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S048)Syncardia Systems, LLC2017-05-24
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S054)Syncardia Systems, LLC2017-05-12
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S052)Syncardia Systems, LLC2017-04-04
Syncardia Temporary Cardio West Total Artificial Heart (TAH-T) (P030011/S049)Syncardia Systems, LLC2017-03-31
SynCardia Temporary Total Artificial Heart (P030011/S047)Syncardia Systems, LLC2017-03-09
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S046)Syncardia Systems, LLC2016-10-12
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S045)Syncardia Systems, LLC2016-09-21
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM (P030011/S044)Syncardia Systems, LLC2016-07-05
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S043)Syncardia Systems, LLC2016-04-27
SYNCARDIA CAMPANION 2 DRIVER SYSTEM (P030011/S039)Syncardia Systems, LLC2016-04-15
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S041)Syncardia Systems, LLC2016-03-22
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S040)Syncardia Systems, LLC2016-03-22
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S042)Syncardia Systems, LLC2016-03-17
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S038)Syncardia Systems, LLC2016-02-22
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S037)Syncardia Systems, LLC2016-01-07
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S036)Syncardia Systems, LLC2015-12-09
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S032)Syncardia Systems, LLC2015-11-27
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S034)Syncardia Systems, LLC2015-11-02
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S035)Syncardia Systems, LLC2015-10-29
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S033)Syncardia Systems, LLC2015-10-22
FREEDOM DRIVER SYSTEM (P030011/S031)Syncardia Systems, LLC2015-07-29
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S030)Syncardia Systems, LLC2015-02-12
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S029)Syncardia Systems, LLC2014-09-29
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S027)Syncardia Systems, LLC2014-09-12
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S026)Syncardia Systems, LLC2014-08-07
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S024)Syncardia Systems, LLC2014-07-02
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S020)Syncardia Systems, LLC2014-06-26
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S025)Syncardia Systems, LLC2014-06-20
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S023)Syncardia Systems, LLC2014-03-18
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S021)Syncardia Systems, LLC2013-12-24
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S022)Syncardia Systems, LLC2013-12-13
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S019)Syncardia Systems, LLC2013-05-30
SYNCARDIA COMPANION 2 DRIVER SYSTEM (P030011/S016)Syncardia Systems, LLC2012-08-20
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S015)Syncardia Systems, LLC2012-08-10
SYNCARDIA COMPANION 2 DRIVER SYSTEM (P030011/S013)Syncardia Systems, LLC2012-07-05
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S012)Syncardia Systems, LLC2012-06-26
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S011)Syncardia Systems, LLC2012-05-16
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S010)Syncardia Systems, LLC2011-02-18
TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S009)Syncardia Systems, LLC2011-01-04
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S008)Syncardia Systems, LLC2010-10-26
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (P030011/S007)Syncardia Systems, LLC2010-04-28
CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S006)Syncardia Systems, LLC2009-12-23
CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM (P030011/S003)Syncardia Systems, LLC2008-08-11
CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM (P030011/S002)Syncardia Systems, LLC2007-05-23
SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S001)Syncardia Systems, LLC2005-10-26
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) (P030011)Syncardia Systems, LLC2004-10-15

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