Syncardia Systems L L C

FDA Filings

This page includes the latest FDA filings for Syncardia Systems L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003761017
FEI Number3003761017
NameSYNCARDIA SYSTEMS, LLC
Owner & OperatorSYNCARDIA SYSTEMS, LLC
Contact Address1992 E. SILVERLAKE RD.
Tucson AZ 85713 US
Official Correspondent
  • Kerri A Hensley
  • x-520-5451234-1206
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1992 E Silverlake Rd
TUCSON, AZ 85713 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart System2020-10-28
SynCardia Systems, LLC
Otc Medication2020-04-18
SynCardia Systems, LLC
Otc Medication2020-04-15
SynCardia Systems, LLC
Hand Sanitizer2020-04-06
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2020-03-12
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2020-01-22
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-11-26
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-08-15
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System2019-07-18
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-06-26
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2019-04-17
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artifical Heart (TAH-t) System2019-02-20
SYNCARDIA SYSTEMS, LLC
Syncardia Temporary Total Artificial Heart (TAH-T) system2019-01-09
SYNCARDIA SYSTEMS, LLC
SynCardia temporaty Total Artificial Heart (TAH-t) System2018-12-17
SYNCARDIA SYSTEMS, LLC
SynCardia Freedom® Driver 2018-07-06
SYNCARDIA SYSTEMS, LLC
SynCardia Hand Pump 2018-07-06
SYNCARDIA SYSTEMS, LLC
SynCardia Companion 2 Driver 2018-07-06
SYNCARDIA SYSTEMS, LLC
SynCardia Freedom® Onboard Battery 2018-07-06
SYNCARDIA SYSTEMS, LLC
SynCardia Companion Rechargeable LI-ION Battery 2018-07-06
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart System 2018-07-06
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System- Companion 2 Driver System2018-07-04
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t)2018-05-02
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Toatl Artificial Heart (TAH-t) System - Companion 2 Driver System2018-04-25
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM2018-03-16
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System / Companion 2 Driver System2017-12-08
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-12-07
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-T) System2017-12-06
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System; Freedom Driver System2017-12-01
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-09-29
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-06-09
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-05-24
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-05-12
SYNCARDIA SYSTEMS, LLC
SynCardia temporary Total Artificial Heart (TAH-t) System2017-04-04
SYNCARDIA SYSTEMS, LLC
Syncardia Temporary Cardio West Total Artificial Heart (TAH-T)2017-03-31
SYNCARDIA SYSTEMS, LLC
SynCardia Temporary Total Artificial Heart2017-03-09
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2016-10-12
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2016-09-21
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM2016-07-05
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-04-27
SYNCARDIA SYSTEMS, LLC
SYNCARDIA CAMPANION 2 DRIVER SYSTEM2016-04-15
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-03-22
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-03-22
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2016-03-17
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2016-02-22
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2016-01-07
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2015-12-09
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2015-11-27
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2015-11-02
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2015-10-29
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2015-10-22
SYNCARDIA SYSTEMS, LLC
FREEDOM DRIVER SYSTEM2015-07-29
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2015-02-12
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2014-09-29
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2014-09-12
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2014-08-07
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2014-07-02
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2014-06-26
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)2014-06-20
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2014-03-18
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2013-12-24
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2013-12-13
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2013-05-30
SYNCARDIA SYSTEMS, LLC
SYNCARDIA COMPANION 2 DRIVER SYSTEM2012-08-20
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2012-08-10
SYNCARDIA SYSTEMS, LLC
SYNCARDIA COMPANION 2 DRIVER SYSTEM2012-07-05
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2012-06-26
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2012-05-16
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2011-02-18
SYNCARDIA SYSTEMS, LLC
TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2011-01-04
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2010-10-26
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART2010-04-28
SYNCARDIA SYSTEMS, LLC
CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2009-12-23
SYNCARDIA SYSTEMS, LLC
CARDIOWEST TEMPORARY TOTAL ARTIFICAL HEART (TAH-T) SYSTEM2008-08-11
SYNCARDIA SYSTEMS, LLC
CardioWest TAH-t2007-11-26
SYNCARDIA SYSTEMS, LLC
CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM2007-05-23
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T)2005-10-26
SYNCARDIA SYSTEMS, LLC
SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)2004-10-15

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    Related Finance Registrations
    U.S. Import Records [external site]
    Import IDShipmentCargo DescriptionQuantity
    201905095415Stadersand,Federal Republic of Germany -> Los Angeles, CaliforniaMOCK TANKS HS CODE 90230080000 SCAC SSLL AMS REF LAX2295821 CAS

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