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ABBOTT MEDICAL

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

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RecordFirmDate
FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S061)ABBOTT MEDICAL2019-04-23
Amplatzer Septal Occluder (P000039/S066)ABBOTT MEDICAL2019-04-18
Therapy Cool Flex, Path Duo, Safire Duo, MediGuide Enabled Ablation Catheter; Mediguide Enabled (P110016/S060)ABBOTT MEDICAL2019-04-11
CardioMEMS HF System (P100045/S036)ABBOTT MEDICAL2019-04-04
SCS EPG Header (P010032/S147)ABBOTT MEDICAL2019-03-26
CardioMEMS HF System (P100045/S039)ABBOTT MEDICAL2019-03-26
Axium Neurostimulator System (P150004/S023)ABBOTT MEDICAL2019-03-26
Amplatzer Patent FOramen Ovale Occluder (P120021/S011)ABBOTT MEDICAL2019-03-25
Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Piccolo Occluder (P020024/S056)ABBOTT MEDICAL2019-03-25
Biocor and Epic Valves (P040021/S040)ABBOTT MEDICAL2019-03-25
Amplatzer Muscular VSD Occluder (P040040/S036)ABBOTT MEDICAL2019-03-25
St. Jude Medical Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valves Graft (P810002/S109)ABBOTT MEDICAL2019-03-25
Trifecta and Trifecta GT surgical Heart Valve (P100029/S039)ABBOTT MEDICAL2019-03-25
Amplatzer Septal Occluder and Amplatzer Cribriform Occluder (P000039/S065)ABBOTT MEDICAL2019-03-25
CardioMEMS HF System (P100045/S038)ABBOTT MEDICAL2019-03-20
MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System (P100009/S028)ABBOTT MEDICAL2019-03-14
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S304)ABBOTT MEDICAL2019-03-13
Multilead Trial Cable (MLTC) (P140009/S045)ABBOTT MEDICAL2019-03-13
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S414)ABBOTT MEDICAL2019-03-13
Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programmer Software (P140033/S041)ABBOTT MEDICAL2019-03-13
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S364)ABBOTT MEDICAL2019-03-13
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S175)ABBOTT MEDICAL2019-03-13
CardioMEMS HF System (P100045/S035)ABBOTT MEDICAL2019-03-13
CardioMEMS HF System (P100045/S037)ABBOTT MEDICAL2019-03-07
AMPLATZER Duct Occluder, Occluder II; AMPLATZER Piccolo Occluder (P020024/S055)ABBOTT MEDICAL2019-03-05
AMPLATZER PFO Occluder (P120021/S010)ABBOTT MEDICAL2019-03-05
AMPLATZER Muscular VSD Occluder (P040040/S035)ABBOTT MEDICAL2019-03-05
FlexAbility and FlexAbility SE Ablation Catheter; FlexAbility Cables, Sensor Enabled (P110016/S059)ABBOTT MEDICAL2019-03-05
AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S064)ABBOTT MEDICAL2019-03-05
Trifecta/Trifecta GT Valves (P100029/S038)ABBOTT MEDICAL2019-03-04
Biocor/Epic Valves (P040021/S039)ABBOTT MEDICAL2019-03-04
Biocor Valve, Supra Valve; Epic Valve, Supra (P040021/S038)ABBOTT MEDICAL2019-02-26
4CH & 8CH Infinity DBS System FLex Extension (P140009/S038)ABBOTT MEDICAL2019-02-14
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) (P160054/S015)ABBOTT MEDICAL2019-01-18
CardioMEMS HF (Heart Failure) System (P100045/S034)ABBOTT MEDICAL2019-01-17
Biocor, Biocor Supra, Epic, Epic Supra Valves (P040021/S037)ABBOTT MEDICAL2019-01-17
Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters (P010032/S146)ABBOTT MEDICAL2019-01-16
Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters (P140009/S044)ABBOTT MEDICAL2019-01-16
AMPLATZER Piccolo Occluder (P020024/S052)ABBOTT MEDICAL2019-01-11
Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C (P110016/S058)ABBOTT MEDICAL2019-01-10
Amplatzer Duct Occluder/Amplatzer Duct Occluder II (P020024/S053)ABBOTT MEDICAL2019-01-08
Amplatzer PFO Occluder (P120021/S009)ABBOTT MEDICAL2019-01-08
HeartMate 3 Left Ventricular Assist System (P160054/S016)ABBOTT MEDICAL2019-01-08
Amplatzer Septal Occluder/Amplatzer Cribriform Occluder (P000039/S063)ABBOTT MEDICAL2019-01-08
Amplatzer Muscular VSD Occluder (P040040/S034)ABBOTT MEDICAL2019-01-08
CARDIOMEMS HF SYSTEM (P100045/S007)ABBOTT MEDICAL2019-01-04
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P030054/S356)ABBOTT MEDICAL2019-01-03
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P960013/S099)ABBOTT MEDICAL2019-01-03
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P140033/S034)ABBOTT MEDICAL2019-01-03
Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P030035/S171)ABBOTT MEDICAL2019-01-03
Proclaim DRG Neurostimulator System IPG (P150004/S027)ABBOTT MEDICAL2018-12-26
Tendril MRI Low Voltage Active (P140033/S044)ABBOTT MEDICAL2018-12-17
IsoFlex Low Voltage Passive (P960030/S065)ABBOTT MEDICAL2018-12-17
OpticSense, Tendril STS, SDX, ST Low Voltage Active (P960013/S106)ABBOTT MEDICAL2018-12-17
Durata, Optisure High Voltage Passive, High Voltage Active (P950022/S126)ABBOTT MEDICAL2018-12-17
Quickflex u, Quartet Cardiac Resynchronization Therapy Passive (P030054/S367)ABBOTT MEDICAL2018-12-17
Tendril STS 2088TC Lead (P140033/S033)ABBOTT MEDICAL2018-12-13
Tendril STS 2088TC Lead (P910023/S410)ABBOTT MEDICAL2018-12-13
Tendril STS 2088TC Lead (P960013/S098)ABBOTT MEDICAL2018-12-13
Tendril STS 2088TC Lead (P030054/S355)ABBOTT MEDICAL2018-12-13
Assurity MRI and Endurity MRI, MRI Activator, and Tendril MRI (P140033/S042)ABBOTT MEDICAL2018-12-13
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, and Quartet CRT Leads (P030054/S365)ABBOTT MEDICAL2018-12-12
Allure, Allure Quadra and Quadra Allure MP (P030035/S176)ABBOTT MEDICAL2018-12-11
Microny Pacemaker (P970013/S080)ABBOTT MEDICAL2018-12-11
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S (P880086/S305)ABBOTT MEDICAL2018-12-11
Tendril SDX Lead, Tendril ST Lead, OptiSense and Tendril STS Lead (P960013/S104)ABBOTT MEDICAL2018-12-11
Durata and Optisure (P950022/S124)ABBOTT MEDICAL2018-12-11
IsoFlex Optim (P960030/S063)ABBOTT MEDICAL2018-12-11
Cortify, Fortify Assura, and Ellipse (P910023/S415)ABBOTT MEDICAL2018-12-11
SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505) (P810002/S107)ABBOTT MEDICAL2018-12-07
Proclaim SCS IPG (P010032/S145)ABBOTT MEDICAL2018-12-06
Proclaim DRG IPG (P150004/S028)ABBOTT MEDICAL2018-12-06
Infinity DBS IPG (P140009/S043)ABBOTT MEDICAL2018-12-06
Durata, Optisure High Voltage Active and Passive Leads (P950022/S125)ABBOTT MEDICAL2018-12-05
Tendril MRI Low Voltage Leads (P140033/S043)ABBOTT MEDICAL2018-12-05
Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads (P960013/S105)ABBOTT MEDICAL2018-12-05
QuickFlex u, Quartet Cardiac Resynchronization Therapy (CRT) Passive Fixation Leads (P030054/S366)ABBOTT MEDICAL2018-12-05
Isoflex Low Voltage Passive Fixation Leads (P960030/S064)ABBOTT MEDICAL2018-12-05
SlimTip DRG Trial Lead Kit, 50cm/90cm, Slim Tip DRG Implant Lead Kit 50cm/90cm, DRG Lead Extension Kit (P150004/S026)ABBOTT MEDICAL2018-12-03
St, Jude Medical Infinity Deep Brain Stimulation (DBS) Leads (P140009/S041)ABBOTT MEDICAL2018-11-14
Proclaim IPG (P010032/S144)ABBOTT MEDICAL2018-11-14
Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve. (P100029/S037)ABBOTT MEDICAL2018-11-14
Thoratec HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S014)ABBOTT MEDICAL2018-11-09
Infinity IPG (P140009/S042)ABBOTT MEDICAL2018-11-09
Durata, Optisure, (P950022/S122)ABBOTT MEDICAL2018-11-07
Tendril MRI (P140033/S039)ABBOTT MEDICAL2018-11-07
QuickFlex u, Quartet (P030054/S361)ABBOTT MEDICAL2018-11-07
Tendrill SDX, OptiSense, Tendrill STS, Tendril ST. (P960013/S102)ABBOTT MEDICAL2018-11-07
Isoflex (P960030/S061)ABBOTT MEDICAL2018-11-07
CardioMEMS HF System (P100045/S033)ABBOTT MEDICAL2018-11-06
Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP (MR Conditi (P030054/S363)ABBOTT MEDICAL2018-11-05
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional) (P910023/S413)ABBOTT MEDICAL2018-11-05
Tendril MRI Lead (P140033/S040)ABBOTT MEDICAL2018-10-31
Left Heart Leads (QuickFlex u and Quartet) (P030054/S362)ABBOTT MEDICAL2018-10-31
Isoflex Low Voltage Leads (P960030/S062)ABBOTT MEDICAL2018-10-31
Tendril and OptiSense Low Voltage Leads (P960013/S103)ABBOTT MEDICAL2018-10-31
Durata and Optisure High Voltage Leads (P950022/S123)ABBOTT MEDICAL2018-10-31
Assurity MRI, Endurity MRI, Tendril MRI, MRI Activator, (P140033/S038)ABBOTT MEDICAL2018-10-24
Durata, Optisure (P950022/S121)ABBOTT MEDICAL2018-10-24
Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D (P880086/S303)ABBOTT MEDICAL2018-10-24
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