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ABBOTT MEDICAL

3,576 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
IsoFlex (P960030/S057)ABBOTT MEDICAL2018-03-20
Durata, Optisure (P950022/S117)ABBOTT MEDICAL2018-03-20
Legacy MDT Pocket Adapter (P140009/S034)ABBOTT MEDICAL2018-03-14
Tendril MRI (P140033/S023)ABBOTT MEDICAL2018-03-13
Amplatzer Septal Occluder / Amplatzer Multi-Fenestrated Septal Occluder-Cribriform Occluder (P000039/S062)ABBOTT MEDICAL2018-03-12
Amplatzer Muscular VSD Occluder (P040040/S033)ABBOTT MEDICAL2018-03-12
FlexAbility Ablation Catheter / FlexAbility Ablation Catheter Sensor Enabled (P110016/S054)ABBOTT MEDICAL2018-03-12
Amplatzer Duct Occluder / Amplatzer Duct Occluder II (P020024/S051)ABBOTT MEDICAL2018-03-12
Amplatzer Patent foramen Ovale Occluder (P120021/S007)ABBOTT MEDICAL2018-03-12
Infinity Family of Implantable Pulse Generators (P140009/S027)ABBOTT MEDICAL2018-03-11
Proclaim Family of Implantable Pulse Generators (P010032/S132)ABBOTT MEDICAL2018-03-11
FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S055)ABBOTT MEDICAL2018-03-09
AMPLATZER PFO Occluder (P120021/S006)ABBOTT MEDICAL2018-03-08
SJM Masters Series Mechanical Heart Valve, 15mm HP (P810002/S101)ABBOTT MEDICAL2018-03-06
Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C (P110016/S053)ABBOTT MEDICAL2018-03-06
CardioMEMS patient and hospital electronics (P100045/S022)ABBOTT MEDICAL2018-03-06
Current, Fortify, Fortify Assura, Ellipse (P910023/S405)ABBOTT MEDICAL2018-03-05
Assurity, Endurity (P880086/S296)ABBOTT MEDICAL2018-03-05
Assurity MRI, Endurity MRI (P140033/S026)ABBOTT MEDICAL2018-03-05
Assure CRT-P (P030035/S167)ABBOTT MEDICAL2018-03-05
Ellipse (P910023/S404)ABBOTT MEDICAL2018-03-05
Trifecta and Trifecta GT (P100029/S030)ABBOTT MEDICAL2018-02-27
Mechanical Heart Valves and Vlaved Grafts (P810002/S106)ABBOTT MEDICAL2018-02-27
CardioMEMS HF System (P100045/S028)ABBOTT MEDICAL2018-02-26
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S031)ABBOTT MEDICAL2018-02-23
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx (P880086/S295)ABBOTT MEDICAL2018-02-22
Microny (P970013/S077)ABBOTT MEDICAL2018-02-22
Durata, Optisure (P950022/S115)ABBOTT MEDICAL2018-02-22
Current+, Fortify, Fortify Assura, Ellipse (P910023/S403)ABBOTT MEDICAL2018-02-22
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tentril STS Lead (P960013/S095)ABBOTT MEDICAL2018-02-22
Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF (P030035/S166)ABBOTT MEDICAL2018-02-22
Assurity MRI, Endurity MRI, Tendril MRI (P140033/S025)ABBOTT MEDICAL2018-02-22
Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet (MR Conditio (P030054/S348)ABBOTT MEDICAL2018-02-22
IsoFlex Optim (P960030/S056)ABBOTT MEDICAL2018-02-22
SCS Accessory and A127 Extension Kits (P010032/S137)ABBOTT MEDICAL2018-02-13
Isoflex Low Voltage Lead (P960030/S055)ABBOTT MEDICAL2018-02-08
Quickflex u and Quartet CRT Leads (P030054/S346)ABBOTT MEDICAL2018-02-08
Tendril and Optisense f Low Voltage Leads (P960013/S094)ABBOTT MEDICAL2018-02-08
Durata and Optisure High Voltage Leads (P950022/S114)ABBOTT MEDICAL2018-02-08
Fortify Assura (P910023/S401)ABBOTT MEDICAL2018-02-06
Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S345)ABBOTT MEDICAL2018-02-06
Accent MRI Pacemaker (P140033/S018)ABBOTT MEDICAL2018-02-02
Promote+, Quadra Assura, Unify, Unify Assura, and Unify Quadra (P030054/S347)ABBOTT MEDICAL2018-02-01
Current+, Ellipse, Fortify, Fortify Assura, and Quadra Assura MP (P910023/S402)ABBOTT MEDICAL2018-02-01
Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL (P880086/S294)ABBOTT MEDICAL2018-02-01
Allure, Allure Quadra, Quadra Allure MP, Anthem, and Frontier II (P030035/S165)ABBOTT MEDICAL2018-02-01
Assurity MRI and Endurity MRI (P140033/S024)ABBOTT MEDICAL2018-02-01
Trifecta Heart Valves (P100029/S029)ABBOTT MEDICAL2018-01-30
Biocor and Epic Heart Valves (P040021/S034)ABBOTT MEDICAL2018-01-30
HeartMate 3™ Left Ventricular Assist System (P160054/S003)ABBOTT MEDICAL2018-01-16
SCS and DBS Leads, Extensions, Anchors, Adapters and Accessories (P010032/S139)ABBOTT MEDICAL2018-01-12
Implantable Pulse Generators (P140009/S033)ABBOTT MEDICAL2018-01-12
Proclaim Elite IPG (P010032/S140)ABBOTT MEDICAL2018-01-10
Infinity IPG (P140009/S035)ABBOTT MEDICAL2018-01-10
Proclaim DRG IPG (P150004/S019)ABBOTT MEDICAL2018-01-10
Tendril MRI Cardiac Lead (P140033/S019)ABBOTT MEDICAL2018-01-07
CardioMems HF System (P100045/S025)ABBOTT MEDICAL2018-01-05
Medical Adhesive (P880086/S292)ABBOTT MEDICAL2018-01-05
IS4/DF4 Connector Sleeve; Suture Sleeve; Suture Sleeve Kit (P950022/S113)ABBOTT MEDICAL2018-01-05
Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug (P910023/S399)ABBOTT MEDICAL2018-01-05
Slit Suture Sleeve; Vein Pick (P030054/S343)ABBOTT MEDICAL2018-01-05
Allure, Allure Quadra, Quadra Allure MP (P030035/S163)ABBOTT MEDICAL2018-01-03
Assurity, Assurity+, Endurity (P880086/S291)ABBOTT MEDICAL2018-01-03
Amplatzer Septal Occluder (P000039/S061)ABBOTT MEDICAL2017-12-26
Biocor Heart Valve (P040021/S033)ABBOTT MEDICAL2017-12-26
Therapy (Flexability) Ablation Catheters (P110016/S052)ABBOTT MEDICAL2017-12-26
Trifecta Heart Valve (P100029/S028)ABBOTT MEDICAL2017-12-26
Implantable Cardioverter Defibrillator (ICD) (P910023/S388)ABBOTT MEDICAL2017-12-19
High Voltage Active Fixation Lead, (P030054/S332)ABBOTT MEDICAL2017-12-19
Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P950022/S109)ABBOTT MEDICAL2017-12-19
Low Voltage Active Fixation Lead (P140033/S010)ABBOTT MEDICAL2017-12-19
SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit. (P150004/S017)ABBOTT MEDICAL2017-12-15
Tendril MRI Leads (P140033/S014)ABBOTT MEDICAL2017-12-12
Unify/ Unify Quadra/ Unify Assura/ Quadra Assura/ Quadra Assura MP (P030054/S342)ABBOTT MEDICAL2017-12-11
Fortify; Fortify Assura (P910023/S398)ABBOTT MEDICAL2017-12-11
Infinity family of DBS IPGs (P140009/S030)ABBOTT MEDICAL2017-12-09
EonC and Eon Mini Neurostimulation System (P010032/S135)ABBOTT MEDICAL2017-12-09
Proclaim Elite family of SCS IPGs (P010032/S134)ABBOTT MEDICAL2017-12-09
Proclaim DRG family of DRG IPGs (P150004/S014)ABBOTT MEDICAL2017-12-09
Axium Clinical and Patient Programmers (P150004/S016)ABBOTT MEDICAL2017-12-08
Fortify Assura , Ellipse (P910023/S397)ABBOTT MEDICAL2017-12-07
Unify/ Unify Quadra/ Unify Assura / Quadra Assura MP (P030054/S341)ABBOTT MEDICAL2017-12-07
Tendril MRI (P140033/S020)ABBOTT MEDICAL2017-12-07
Tendril ST; Tendril STS; Optisense (P960013/S093)ABBOTT MEDICAL2017-12-07
FlexAbility Ablation Catheter/ FlexAbility Ablation Catheter, Sensor Enabled (P110016/S051)ABBOTT MEDICAL2017-11-29
Proclaim DRG Implantable Pulse Generator (P150004/S018)ABBOTT MEDICAL2017-11-28
Proclaim Family of Implantable Pulse Generators (P010032/S138)ABBOTT MEDICAL2017-11-28
Infinity Family of Implantable Pulse Generators (P140009/S032)ABBOTT MEDICAL2017-11-28
Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S027)ABBOTT MEDICAL2017-11-21
Genesis IPG/Eon IPG/Eon C IPG/Eon Mini IPG/Protege IPG/Protege MRI IPG/Prodigy/Prodigy MRI IPG/Proclaim IPG/Port Plug Ac (P010032/S136)ABBOTT MEDICAL2017-11-21
Brio IPG/Infinity IPG (P140009/S031)ABBOTT MEDICAL2017-11-21
SJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech (P810002/S105)ABBOTT MEDICAL2017-11-16
Assurity MRI and Endurity MRI family of Pacemakers, (P140033/S017)ABBOTT MEDICAL2017-11-09
Microny family of Pacemakers (P970013/S075)ABBOTT MEDICAL2017-11-09
Anthem, Allure/RF,Allura Quadra/RF family of CRT-Ps (P030035/S162)ABBOTT MEDICAL2017-11-09
Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A (P030054/S340)ABBOTT MEDICAL2017-11-09
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S290)ABBOTT MEDICAL2017-11-09
Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's (P910023/S396)ABBOTT MEDICAL2017-11-09
Unify, Unify Quadra, Unify Assura, Quadra Assura, Ellipse (P030054/S339)ABBOTT MEDICAL2017-11-08
Assurity MRI, Endurity MRI (P140033/S016)ABBOTT MEDICAL2017-11-08
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