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St Jude Medical Inc.

18 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs) recall (Z-2070-2019)St Jude Medical Inc.2019-08-02
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs) recall (Z-2071-2019)St Jude Medical Inc.2019-08-02
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 0541473450773 recall (Z-2072-2019)St Jude Medical Inc.2019-08-02
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs) recall (Z-2073-2019)St Jude Medical Inc.2019-08-02
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 0541473450758 recall (Z-2074-2019)St Jude Medical Inc.2019-08-02
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 0541473450761 recall (Z-2075-2019)St Jude Medical Inc.2019-08-02
Proclaim DRG Implantable Pulse Generator, Model Number 3664 recall (Z-1170-2018)St. Jude Medical, Inc.2018-03-23
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241 recall (Z-0003-2018)St Jude Medical Inc.2017-10-10
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and recall (Z-0004-2018)St Jude Medical Inc.2017-10-10
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40 recall (Z-0115-2017)St Jude Medical Inc.2016-10-21
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Uni recall (Z-0116-2017)St Jude Medical Inc.2016-10-21
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, recall (Z-0117-2017)St Jude Medical Inc.2016-10-21
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. J recall (Z-2718-2014)St. Jude Medical, Inc.2014-09-29
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. J recall (Z-2719-2014)St. Jude Medical, Inc.2014-09-29
St. Jude Medical, AGA Medical corporation, AMPLATZER TorqVue FX Delivery System. Model #'s recall (Z-0763-2013)St Jude Medical Inc2013-02-11
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx recall (Z-0617-2013)St Jude Medical Inc2012-12-28
The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablatio recall (Z-1032-2012)St Jude Medical Inc2012-02-14
Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor C recall (Z-0946-2009)St. Jude Medical Inc2009-01-30

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