St Jude Medical Inc

FDA Filings

This page includes the latest FDA filings for St Jude Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
ST. JUDE MEDICAL, INC.
OPTIS™ 10149432021-06-24
ST. JUDE MEDICAL, INC.
OPTIS™ 10149452021-06-24
ST. JUDE MEDICAL, INC.
OPTIS™ 10149442021-06-24
ST. JUDE MEDICAL, INC.
OPTIS™ 10149332021-06-24
ST. JUDE MEDICAL, INC.
OPTIS™ 10149362021-06-24
ST. JUDE MEDICAL, INC.
OPTIS™ 10149322021-06-18
ST. JUDE MEDICAL, INC.
OPTIS™ 10149352021-06-18
ST. JUDE MEDICAL, INC.
OPTIS™ 10149342021-06-18
ST. JUDE MEDICAL, INC.
OPTIS™ 10149382021-06-18
ST. JUDE MEDICAL, INC.
OPTIS™ 10149372021-06-18
ST. JUDE MEDICAL, INC.
N/A C128492021-06-14
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102252021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102242021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102232021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102222021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102212021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102202021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102192021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102182021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102172021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102162021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102152021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102142021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102132021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102122021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102112021-06-10
ST. JUDE MEDICAL, INC.
CPS DIRECT™ 4102102021-06-10
ST. JUDE MEDICAL, INC.
CPS™ 4101942021-06-10
St. Jude Medical, Inc.
Epic and Epic Supra Tissue Heart Valves2021-05-28
St. Jude Medical, Inc.
Microny2021-04-09
St. Jude Medical, Inc.
Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional)2021-04-09
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL2021-04-09
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI and Tendril MRI2021-04-09
St. Jude Medical, Inc.
Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional)2021-04-09
ST. JUDE MEDICAL, INC.
WorkMate Claris™ H8000122021-03-30
ST. JUDE MEDICAL, INC.
WorkMate™ Unity™ H8000092021-03-30
ST. JUDE MEDICAL, INC.
WorkMate™ Scribe™ H8000082021-03-30
ST. JUDE MEDICAL, INC.
WorkMate™ Claris™ H8000072021-03-30
ST. JUDE MEDICAL, INC.
WorkMate™ Unity™ H8000102021-03-30
ST. JUDE MEDICAL, INC.
WorkMate™ Unity™ H8000112021-03-30
ST. JUDE MEDICAL, INC.
SMK-S505-22 SMK-S505-222021-02-25
ST. JUDE MEDICAL, INC.
SMK-S1510-20 SMK-S1510-202021-02-25
ST. JUDE MEDICAL, INC.
SMK-S1010-22 SMK-S1010-222021-02-25
ST. JUDE MEDICAL, INC.
SMK-S1010-20 SMK-S1010-202021-02-25
ST. JUDE MEDICAL, INC.
SMK-S1005-20 SMK-S1005-202021-02-25
ST. JUDE MEDICAL, INC.
SMK-S1002-22 SMK-S1002-222021-02-25
ST. JUDE MEDICAL, INC.
SMK-C1510-20 SMK-C1510-202021-02-25
ST. JUDE MEDICAL, INC.
SMK-C1010-22 SMK-C1010-222021-02-25
ST. JUDE MEDICAL, INC.
SMK-C1010-20 SMK-C1010-202021-02-25
ST. JUDE MEDICAL, INC.
SMK-C1010-18 SMK-C1010-182021-02-25
ST. JUDE MEDICAL, INC.
SMK-C1005-22 SMK-C1005-222021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4067242021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4069622021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063352021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063082021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063062021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063032021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063332021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063312021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063072021-02-25
ST. JUDE MEDICAL, INC.
Fast-Cath™ 4063012021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085442021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085422021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085402021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085452021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085432021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085412021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085302021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085272021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085102021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085382021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085372021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085352021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085342021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085292021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085282021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085262021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085252021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085392021-02-25
ST. JUDE MEDICAL, INC.
Engage™ C4085362021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4078302021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076392021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076632021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076602021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076592021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076572021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076402021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076552021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076542021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076512021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076502021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076492021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076482021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076472021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066902021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066882021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066872021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066862021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066852021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066822021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066812021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076532021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076522021-02-25
ST. JUDE MEDICAL, INC.
Ultimum™ 4076382021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066832021-02-25
ST. JUDE MEDICAL, INC.
Maximum™ 4066522021-02-25
St. Jude Medical, Inc.
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)2020-12-15
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL2020-12-15
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI, Tendril MRI2020-12-15
St. Jude Medical, Inc.
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional)2020-12-15
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves2020-12-10
St. Jude Medical, Inc.
Assurity, Assurity+, and Endurity2020-10-29
St. Jude Medical, Inc.
Assurity MRI and Endurity MRI2020-10-29
St. Jude Medical, Inc.
Microny2020-10-26
St. Jude Medical, Inc.
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional)2020-10-26
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL2020-10-26
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI, Tendril MRI2020-10-26
St. Jude Medical, Inc.
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional)2020-10-26
St. Jude Medical, Inc.
Durata, Optisure2020-10-16
St. Jude Medical, Inc.
Trifecta and Trifecta Valve with Glide Technology2020-10-14
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic, Epic Supra2020-10-14
St. Jude Medical, Inc.
Durata And Optisure HV Passive Steroid Eluting Cardiac Leads2020-06-30
St. Jude Medical, Inc.
Durata and Optisure High Voltage Leads2020-06-18
St. Jude Medical, Inc.
Tendril MRl2020-06-18
St. Jude Medical, Inc.
Durata HV Leads2020-06-04
St. Jude Medical, Inc.
SJM Masters Valved Graft with Hemashield graft technology2020-05-26
St. Jude Medical, Inc.
Tendril MRI2020-05-22
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust2020-05-21
St. Jude Medical, Inc.
Assurity MRI and Endurity MRI2020-05-21
St. Jude Medical, Inc.
Allure, Allure Quadra, and Quadra Allure MP2020-05-21
St. Jude Medical, Inc.
Optisure High Voltage Leads2020-05-15
St. Jude Medical, Inc.
Mechanical Heart Valve2020-05-12
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic, and Epic Supra Valves2020-04-25
St. Jude Medical, Inc.
Durata, Optisure2020-03-26
St. Jude Medical, Inc.
Tendril MRI2020-03-26
St. Jude Medical, Inc.
Microny2020-02-28
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust2020-02-28
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI2020-02-28
St. Jude Medical, Inc.
Allure, Allure Quadra, and Quadra Allure MP2020-02-28
St. Jude Medical, Inc.
Durata and Optisure2020-02-24
St. Jude Medical, Inc.
Endurity, Endurity Core, and Assurity pacemakers2020-01-06
St. Jude Medical, Inc.
Endurity, Assurity, and Accent2020-01-06
St. Jude Medical, Inc.
Endurity MRI, and Assurity MRI2020-01-06
St. Jude Medical, Inc.
Assurity MRI, Endurity MRI2020-01-06
St. Jude Medical, Inc.
Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP2020-01-06
St. Jude Medical, Inc.
Microny family of Pacemakers2019-12-23
St. Jude Medical, Inc.
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps2019-12-23
St. Jude Medical, Inc.
Endurity, Endurity Core, Assurity and Assurity +2019-12-06
St. Jude Medical, Inc.
Assurity MRI and Endurity MRI Pacemakers2019-12-06
St. Jude Medical, Inc.
Trifecta and Trifecta GT Heart Valves2019-12-04
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic and Epic Supra Heart Valves2019-12-04
St. Jude Medical, Inc.
Durata and Optisure HV Active Steroid Eluting Cardiac Leads2019-10-24
St. Jude Medical, Inc.
TENDRIL MRI2019-10-24
St. Jude Medical, Inc.
Tendril MRI Steroid Eluting Cardiac Leads2019-08-30
St. Jude Medical, Inc.
Tendril MRI Steroid Eluting Cardiac Leads2019-05-29
St. Jude Medical, Inc.
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT)2019-05-20
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic, and Epic Supra Valves2019-05-20
St. Jude Medical, Inc.
St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft2019-03-25
St. Jude Medical, Inc.
Trifecta and Trifecta GT surgical Heart Valve2019-03-25
St. Jude Medical, Inc.
Biocor and Epic Valves2019-03-25
St. Jude Medical, Inc.
Assurity, Assurity+, Endurity, Accent family of Pacemakers2019-03-13
St. Jude Medical, Inc.
Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software2019-03-13
St. Jude Medical, Inc.
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps2019-03-13
St. Jude Medical, Inc.
Trifecta/Trifecta GT Valves2019-03-04
St. Jude Medical, Inc.
Biocor/Epic Valves2019-03-04
St. Jude Medical, Inc.
Biocor Valve, Supra Valve; Epic Valve, Supra2019-02-26
St. Jude Medical, Inc.
Biocor, Biocor Supra, Epic, Epic Supra Valves2019-01-17
St. Jude Medical, Inc.
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)2019-01-03
St. Jude Medical, Inc.
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)2019-01-03
St. Jude Medical, Inc.
Durata, Optisure High Voltage Passive, High Voltage Active2018-12-17
St. Jude Medical, Inc.
Tendril MRI Low Voltage Active2018-12-17
St. Jude Medical, Inc.
Assurity MRI and Endurity MRI, MRI Activator, and Tendril MRI2018-12-13
St. Jude Medical, Inc.
Tendril STS 2088TC Lead2018-12-13
St. Jude Medical, Inc.
Microny Pacemaker2018-12-11
St. Jude Medical, Inc.
Durata and Optisure2018-12-11
St. Jude Medical, Inc.
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S2018-12-11
St. Jude Medical, Inc.
Allure, Allure Quadra and Quadra Allure MP2018-12-11
St. Jude Medical, Inc.
SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505)2018-12-07
St. Jude Medical, Inc.
Durata, Optisure High Voltage Active and Passive Leads2018-12-05
St. Jude Medical, Inc.
Tendril MRI Low Voltage Leads2018-12-05
St. Jude Medical, Inc.
Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve.2018-11-14
St. Jude Medical, Inc.
Durata, Optisure,2018-11-07
St. Jude Medical, Inc.
Tendril MRI2018-11-07
St. Jude Medical, Inc.
Advisor HD Grid Mapping Catheter, Sensor Enabled2018-04-23
St. Jude Medical, Inc.
Confirm Rx Insertable Cardiac Monitor (ICM) System2017-09-29
ST. JUDE MEDICAL INC.
PressureWire X Guidewire2016-08-15
ST JUDE MEDICAL, INC.
Nanostim Introducer Kit2016-05-19
St Jude Medical, Inc
The Nanostim Introducer Kit2016-04-14
ST. JUDE MEDICAL, INC.
NANOSTIM INTRODUCER KIT2014-12-17
ST. JUDE MEDICAL, INC.
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)2014-05-28
ST. JUDE MEDICAL, INC.
ENLIGHTN RENAL GUIDE CATHETER2014-01-31
ST. JUDE MEDICAL, INC.
6F PROXIS SYSTEM2008-10-02
ST. JUDE MEDICAL, INC.
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)2004-12-17
ST. JUDE MEDICAL, INC.
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)2002-09-19
ST. JUDE MEDICAL, INC.
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)2002-01-15
ST. JUDE MEDICAL, INC.
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)2002-01-04
ST. JUDE MEDICAL, INC.
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX2000-05-31
ST. JUDE MEDICAL, INC.
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX2000-05-24
ST. JUDE MEDICAL, INC.
SJM TAILOR ANNULOPLASTY RING, MODEL TARN2000-02-17
ST. JUDE MEDICAL, INC.
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M1997-02-14
ST. JUDE MEDICAL, INC.
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING1995-02-10
ST. JUDE MEDICAL, INC.
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI1994-09-28
ST. JUDE MEDICAL, INC.
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP1992-05-21
ST. JUDE MEDICAL, INC.
BIFLEX(TM) ANNULOPLASTY RING1991-01-18
ST. JUDE MEDICAL, INC.
HYCULT DIAMOND CORONARY BYPASS KNIFE1990-03-19
ST. JUDE MEDICAL, INC.
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP1989-09-26

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092139174Shanghai ,China (Mainland) -> Los Angeles, CaliforniaRF DISPOSABLE GROUNDING PAD7 PKG
2020082141660Shanghai ,China (Mainland) -> Los Angeles, CaliforniaRF DISPOSABLE GROUNDING PAD7 CTN
2020081853076Shanghai ,China (Mainland) -> Los Angeles, CaliforniaRF DISPOSABLE GROUNDING PAD7 CTN
2020073142007Shanghai ,China (Mainland) -> Los Angeles, CaliforniaRF DISPOSABLE GROUNDING PAD7 PKG
2020061743276Shanghai ,China (Mainland) -> Los Angeles, CaliforniaRF DISPOSABLE GROUNDING PAD14 PKG
2020051653828Shanghai ,China (Mainland) -> Long Beach, CaliforniaRF DISPOSABLE GROUNDING PAD14 PKG
2020042241057Shanghai ,China (Mainland) -> Los Angeles, CaliforniaRF DISPOSABLE GROUNDING PAD125 PKG
2020041645986Yantian,China (Mainland) -> Tacoma, WashingtonTOOLING CASE .500 CTN

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