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ABBOTT MEDICAL

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

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RecordFirmDate
Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD (P910023/S429)ABBOTT MEDICAL2020-09-15
Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D (P030054/S381)ABBOTT MEDICAL2020-09-15
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S167)ABBOTT MEDICAL2020-08-18
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S042)ABBOTT MEDICAL2020-08-18
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S063)ABBOTT MEDICAL2020-08-18
CardioMEMS HS System (P100045/S045)ABBOTT MEDICAL2020-08-14
Infinity Deep Brain Stimulation (DBS) System (P140009/S061)ABBOTT MEDICAL2020-08-12
Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT (P910023/S431)ABBOTT MEDICAL2020-08-06
Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT (P030054/S383)ABBOTT MEDICAL2020-08-06
CardioMEMS HF System (P100045/S043)ABBOTT MEDICAL2020-08-04
CardioMEMS HF System (P100045/S044)ABBOTT MEDICAL2020-07-28
HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S029)ABBOTT MEDICAL2020-07-10
Amplatzer Piccolo Occluder (P020024/S062)ABBOTT MEDICAL2020-07-09
Infinity DBS IPG (P140009/S058)ABBOTT MEDICAL2020-07-01
Proclaim DRG IPG (P150004/S037)ABBOTT MEDICAL2020-07-01
Proclaim family of SCS IPG (P010032/S162)ABBOTT MEDICAL2020-07-01
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S050)ABBOTT MEDICAL2020-06-30
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S423)ABBOTT MEDICAL2020-06-30
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S374)ABBOTT MEDICAL2020-06-30
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S178)ABBOTT MEDICAL2020-06-30
Microny family of Pacemakers (P970013/S082)ABBOTT MEDICAL2020-06-30
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S308)ABBOTT MEDICAL2020-06-30
Durata And Optisure HV Passive Steroid Eluting Cardiac Leads (P950022/S134)ABBOTT MEDICAL2020-06-30
HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S025)ABBOTT MEDICAL2020-06-26
Accent MRI Pacemaker (P140033/S054)ABBOTT MEDICAL2020-06-26
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S076)ABBOTT MEDICAL2020-06-26
Isoflex (P960030/S069)ABBOTT MEDICAL2020-06-18
Tendril MRl (P140033/S059)ABBOTT MEDICAL2020-06-18
Durata and Optisure High Voltage Leads (P950022/S133)ABBOTT MEDICAL2020-06-18
Tendril SDX, OptiSense, Tendril STS, Tendril ST (P960013/S113)ABBOTT MEDICAL2020-06-18
Quickflex µ, Quartet (P030054/S379)ABBOTT MEDICAL2020-06-18
OptiSense Steroid Eluting Cardiac Lead (P960013/S112)ABBOTT MEDICAL2020-06-17
HeartMate 3™ (HM3) Left Ventricular Assist System (LVAS) (P160054/S030)ABBOTT MEDICAL2020-06-13
Proclaim DRG IPG (P150004/S033)ABBOTT MEDICAL2020-06-05
Proclaim family of SCS IPGs (P010032/S156)ABBOTT MEDICAL2020-06-05
Infinity Family of DBS IPGs (P140009/S052)ABBOTT MEDICAL2020-06-05
FlexAbility and FlexAbility SE Ablation Catheter, FlexAbility Cables Sensor Enabled (P110016/S069)ABBOTT MEDICAL2020-06-04
Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder (P000039/S073)ABBOTT MEDICAL2020-06-04
Dorsal Root Ganglion (DRG) Stimulation (P150004/S039)ABBOTT MEDICAL2020-06-04
Amplatzer Muscular VSD Occluder (P040040/S043)ABBOTT MEDICAL2020-06-04
Durata HV Leads (P950022/S132)ABBOTT MEDICAL2020-06-04
Amplatzer PFO Occluder (P120021/S018)ABBOTT MEDICAL2020-06-04
Deep Brain Stimulation (DBS) (P140009/S060)ABBOTT MEDICAL2020-06-04
Spinal Cord Stimulation (SCS) (P010032/S164)ABBOTT MEDICAL2020-06-04
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S064)ABBOTT MEDICAL2020-06-04
Deep Brain Stimulation Therapy (P140009/S059)ABBOTT MEDICAL2020-05-30
Dorsal Root Ganglion Stimulator for Pain Relief (P150004/S038)ABBOTT MEDICAL2020-05-30
Totally Implanted Spinal Cord Stimulator for Pain Relief (P010032/S163)ABBOTT MEDICAL2020-05-30
SJM Masters Valved Graft with Hemashield graft technology (P810002/S112)ABBOTT MEDICAL2020-05-26
AMPLATZER PFO Occluder (P120021/S017)ABBOTT MEDICAL2020-05-23
AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo) (P020024/S063)ABBOTT MEDICAL2020-05-23
AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S072)ABBOTT MEDICAL2020-05-23
AMPLATZER Muscular VSD Occluder (P040040/S042)ABBOTT MEDICAL2020-05-23
Tendril MRI (P140033/S057)ABBOTT MEDICAL2020-05-22
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust (P880086/S313)ABBOTT MEDICAL2020-05-21
Allure, Allure Quadra, and Quadra Allure MP (P030035/S181)ABBOTT MEDICAL2020-05-21
Fortify, Fortify Assura, and Ellipse (P910023/S427)ABBOTT MEDICAL2020-05-21
Assurity MRI and Endurity MRI (P140033/S058)ABBOTT MEDICAL2020-05-21
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads (P030054/S378)ABBOTT MEDICAL2020-05-21
SJM Masters HP Valved Graft (P810002/S108)ABBOTT MEDICAL2020-05-18
Durata and Optisure High Voltage Lead (P950022/S112)ABBOTT MEDICAL2020-05-17
Optisure High Voltage Leads (P950022/S131)ABBOTT MEDICAL2020-05-15
Assurity, Endurity Core Family of Pacemakers (P880086/S306)ABBOTT MEDICAL2020-05-13
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S048)ABBOTT MEDICAL2020-05-13
Mechanical Heart Valve (P810002/S111)ABBOTT MEDICAL2020-05-12
Proclaim family of SCS IPGs (P010032/S160)ABBOTT MEDICAL2020-05-06
Proclaim DRG IPG (P150004/S035)ABBOTT MEDICAL2020-05-06
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S036)ABBOTT MEDICAL2020-05-06
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S161)ABBOTT MEDICAL2020-05-06
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S057)ABBOTT MEDICAL2020-05-06
Infinity DBS IPGs (P140009/S056)ABBOTT MEDICAL2020-05-06
Biocor, Biocor Supra, Epic, and Epic Supra Valves (P040021/S043)ABBOTT MEDICAL2020-04-25
Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Cool Path Duo, MediGuide Enabled, and Safi (P110016/S067)ABBOTT MEDICAL2020-04-24
Amplatzer PFO Occluder (P120021/S015)ABBOTT MEDICAL2020-04-16
Amplatzer Muscular VSD Occluder (P040040/S040)ABBOTT MEDICAL2020-04-16
FlexAbility and FlexAbility SE Ablation Catheter (P110016/S068)ABBOTT MEDICAL2020-04-16
Amplatzer Septal Occluder (P000039/S070)ABBOTT MEDICAL2020-04-16
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, and Amplatzer Piccolo Occluder (P020024/S060)ABBOTT MEDICAL2020-04-16
HeartMate 3™ (HM3) Left Ventricular Assist System (P160054/S028)ABBOTT MEDICAL2020-04-16
Amplatzer PFO Occluder (P120021/S014)ABBOTT MEDICAL2020-04-15
Amplatzer Septal Occluder/Amplatzer Cribriform Occluder (P000039/S069)ABBOTT MEDICAL2020-04-15
Amplatzer Muscular VSD Occluder (P040040/S039)ABBOTT MEDICAL2020-04-15
Amplatzer Duct Occluder/Amplatzer Duct Occluder II/Amplatzer Piccolo Occluder (P020024/S059)ABBOTT MEDICAL2020-04-15
CardioMEMS HF System (P100045/S042)ABBOTT MEDICAL2020-04-14
HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S026)ABBOTT MEDICAL2020-04-09
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S077)ABBOTT MEDICAL2020-04-09
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S027)ABBOTT MEDICAL2020-03-30
Tendril SDX, OptiSense, Tendril STS, and Tendril ST (P960013/S111)ABBOTT MEDICAL2020-03-26
Durata, Optisure (P950022/S130)ABBOTT MEDICAL2020-03-26
Isoflex (P960030/S068)ABBOTT MEDICAL2020-03-26
Tendril MRI (P140033/S056)ABBOTT MEDICAL2020-03-26
Quickflex, Quartet (P030054/S377)ABBOTT MEDICAL2020-03-26
Ellipse DR and Ellipse VR (P910023/S426)ABBOTT MEDICAL2020-03-13
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S159)ABBOTT MEDICAL2020-03-04
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S055)ABBOTT MEDICAL2020-03-04
Therapy Cool Path Duo Ablation Catheter (P110016/S066)ABBOTT MEDICAL2020-03-04
Fortify, Fortify Assura, and Ellipse (P910023/S425)ABBOTT MEDICAL2020-02-28
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust (P880086/S312)ABBOTT MEDICAL2020-02-28
Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI (P140033/S055)ABBOTT MEDICAL2020-02-28
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet (P030054/S376)ABBOTT MEDICAL2020-02-28
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