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ABBOTT MEDICAL

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

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RecordFirmDate
Microny (P970013/S083)ABBOTT MEDICAL2020-02-28
Allure, Allure Quadra, and Quadra Allure MP (P030035/S180)ABBOTT MEDICAL2020-02-28
MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System (P100009/S037)ABBOTT MEDICAL2020-02-26
Durata and Optisure (P950022/S129)ABBOTT MEDICAL2020-02-24
CardioMEMS HF System (P100045/S041)ABBOTT MEDICAL2020-02-05
HeartMate 3™ Left Ventricular Assist System (P160054/S021)ABBOTT MEDICAL2020-01-27
HeartMate II Left Ventricular Assist System (P060040/S073)ABBOTT MEDICAL2020-01-27
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG (P010032/S158)ABBOTT MEDICAL2020-01-10
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG. (P150004/S034)ABBOTT MEDICAL2020-01-10
Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG (P140009/S054)ABBOTT MEDICAL2020-01-10
Current+, Fortify, Fortify Assura, Ellipse (P910023/S424)ABBOTT MEDICAL2020-01-06
Assurity MRI, Endurity MRI (P140033/S052)ABBOTT MEDICAL2020-01-06
Promote+, Unify, Unify Quandra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S375)ABBOTT MEDICAL2020-01-06
Endurity, Assurity, and Accent (P880086/S310)ABBOTT MEDICAL2020-01-06
Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP (P030035/S179)ABBOTT MEDICAL2020-01-06
Endurity, Endurity Core, and Assurity pacemakers (P880086/S311)ABBOTT MEDICAL2020-01-06
Endurity MRI, and Assurity MRI (P140033/S053)ABBOTT MEDICAL2020-01-06
St. Jude Medical Infinity DBS Implantable Pulse Generator (P140009/S039)ABBOTT MEDICAL2020-01-02
HeartMate 3 Left Ventricular Assist System (P160054/S024)ABBOTT MEDICAL2019-12-30
Assurity, Assurity+, Endurity, Accent family of Pacemaker (P880086/S307)ABBOTT MEDICAL2019-12-23
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S177)ABBOTT MEDICAL2019-12-23
Microny family of Pacemakers (P970013/S081)ABBOTT MEDICAL2019-12-23
Assurity MRI and Endurity MRI family of Pacemakers (P140033/S049)ABBOTT MEDICAL2019-12-23
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S373)ABBOTT MEDICAL2019-12-23
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S422)ABBOTT MEDICAL2019-12-23
Quadripolar Pacing (P030054/S372)ABBOTT MEDICAL2019-12-20
Tendril ST and Tendril STS Low Voltage Leads (P960013/S110)ABBOTT MEDICAL2019-12-17
Assurity MRI and Endurity MRI Pacemakers (P140033/S051)ABBOTT MEDICAL2019-12-06
Endurity, Endurity Core, Assurity and Assurity + (P880086/S309)ABBOTT MEDICAL2019-12-06
Biocor, Biocor Supra, Epic and Epic Supra Heart Valves (P040021/S042)ABBOTT MEDICAL2019-12-04
Trifecta and Trifecta GT Heart Valves (P100029/S042)ABBOTT MEDICAL2019-12-04
HeartMate 3 Left Ventricular Assist System (P160054/S022)ABBOTT MEDICAL2019-11-20
HeartMate II Left Ventricular Assist System (P060040/S074)ABBOTT MEDICAL2019-11-20
Axium Neurostimulator System (P150004/S032)ABBOTT MEDICAL2019-11-19
Genesis Neurostimulation System (P010032/S155)ABBOTT MEDICAL2019-11-19
Brio Neurostimulation System (P140009/S051)ABBOTT MEDICAL2019-11-19
Ellipse ICD Devices (P910023/S421)ABBOTT MEDICAL2019-11-14
CardioMEMS HF System (P100045/S040)ABBOTT MEDICAL2019-10-29
Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder (P000039/S068)ABBOTT MEDICAL2019-10-25
Tendril ST/STS Steroid Eluting Cardiac Leads (P960013/S108)ABBOTT MEDICAL2019-10-25
Amplatzer PFO Occluder (P120021/S013)ABBOTT MEDICAL2019-10-25
Amplatzer Muscular VSD Occluder (P040040/S038)ABBOTT MEDICAL2019-10-25
Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder (P020024/S058)ABBOTT MEDICAL2019-10-25
FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled (P110016/S065)ABBOTT MEDICAL2019-10-25
TENDRIL MRI (P140033/S047)ABBOTT MEDICAL2019-10-24
TENDRIL, OPTISENSE (P960013/S109)ABBOTT MEDICAL2019-10-24
Durata and Optisure HV Active Steroid Eluting Cardiac Leads (P950022/S128)ABBOTT MEDICAL2019-10-24
ISOFLEX (P960030/S067)ABBOTT MEDICAL2019-10-24
Assurity MRI Pacemakers and Endurity MRI Pacemakers (P140033/S031)ABBOTT MEDICAL2019-10-18
Ellipse hybrid (P910023/S420)ABBOTT MEDICAL2019-10-18
Assurity Pacemaker & Endurity Pacemaker (P880086/S299)ABBOTT MEDICAL2019-10-18
Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD (P910023/S419)ABBOTT MEDICAL2019-10-15
Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D (P030054/S371)ABBOTT MEDICAL2019-10-15
FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S064)ABBOTT MEDICAL2019-10-09
MitraClip G4 Clip Delivery System (P100009/S036)ABBOTT MEDICAL2019-09-30
8-Channel Adapters (P140009/S049)ABBOTT MEDICAL2019-09-26
Torque Wrench (P010032/S154)ABBOTT MEDICAL2019-09-26
Infinity family of DBS IPGs (P140009/S046)ABBOTT MEDICAL2019-09-17
Proclaim family of SCS IPGs (P010032/S149)ABBOTT MEDICAL2019-09-17
Proclaim DRG IPG Clinical Programmer App (P150004/S029)ABBOTT MEDICAL2019-09-17
HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S023)ABBOTT MEDICAL2019-09-12
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S075)ABBOTT MEDICAL2019-09-12
MitraClip NTR, XTR and G4 Clip Delivery System (P100009/S035)ABBOTT MEDICAL2019-09-11
Proclaim Spinal Cord Stimulation (SCS) IPG Family (P010032/S151)ABBOTT MEDICAL2019-09-09
Infinity Deep Brain Stimulation (DBS) System (P140009/S050)ABBOTT MEDICAL2019-09-05
Quadra Assura, Unify, Unify Assura, and Unify Quadra CRT-D Devices (P030054/S370)ABBOTT MEDICAL2019-09-04
Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices (P910023/S418)ABBOTT MEDICAL2019-09-04
Tendril MRI Steroid Eluting Cardiac Leads (P140033/S046)ABBOTT MEDICAL2019-08-30
MitraClip NT, NTR, XTR, G4 Clip Delivery System (P100009/S034)ABBOTT MEDICAL2019-08-30
HeartMate 3™ Left Ventricular Assist System (P160054/S020)ABBOTT MEDICAL2019-08-25
AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S057)ABBOTT MEDICAL2019-08-22
AMPLATZER PFO OCCLUDER (P120021/S012)ABBOTT MEDICAL2019-08-22
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S037)ABBOTT MEDICAL2019-08-22
THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S067)ABBOTT MEDICAL2019-08-22
THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S063)ABBOTT MEDICAL2019-08-22
Fortify and Fortify Assura ICD Devices (P910023/S417)ABBOTT MEDICAL2019-08-19
Unify, Unify Quadra/Assura and Quadra Assura/MP (P030054/S369)ABBOTT MEDICAL2019-08-19
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S019)ABBOTT MEDICAL2019-08-12
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S072)ABBOTT MEDICAL2019-08-12
Axium Neurostimulator System (P150004/S030)ABBOTT MEDICAL2019-07-31
Axium Neurostimulator System (P150004/S031)ABBOTT MEDICAL2019-07-29
BRIO NEUROSTIMULATION SYSTEM (P140009/S048)ABBOTT MEDICAL2019-07-29
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S153)ABBOTT MEDICAL2019-07-29
MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter (P100009/S031)ABBOTT MEDICAL2019-07-26
MitraClip XTR Clip Delivery System (P100009/S033)ABBOTT MEDICAL2019-07-26
MitraClip NT, NTR, and XTR Clip Delivery System (P100009/S032)ABBOTT MEDICAL2019-07-18
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S152)ABBOTT MEDICAL2019-07-17
Genesis Neurostimulation System (P010032/S150)ABBOTT MEDICAL2019-07-15
Brio Neurostimulation System (P140009/S047)ABBOTT MEDICAL2019-07-15
MitraClip G4 System (P100009/S029)ABBOTT MEDICAL2019-07-09
HeartMate 3 Left Ventricular Assist System (P160054/S017)ABBOTT MEDICAL2019-06-04
MitraClip System (NTR and XTR) (P100009/S030)ABBOTT MEDICAL2019-06-03
Torque Wrench/Torque Driver (P910023/S416)ABBOTT MEDICAL2019-05-30
Tendril MRI Steroid Eluting Cardiac Leads (P140033/S045)ABBOTT MEDICAL2019-05-29
AMPLATZER PFO Occluder (P120021/S008)ABBOTT MEDICAL2019-05-23
Trifecta Valve and Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S040)ABBOTT MEDICAL2019-05-20
Biocor, Biocor Supra, Epic, and Epic Supra Valves (P040021/S041)ABBOTT MEDICAL2019-05-20
FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enable (Flex SE) (P110016/S062)ABBOTT MEDICAL2019-05-07
Proclaim SCS Neurostimulation System FW (P010032/S148)ABBOTT MEDICAL2019-05-03
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S018)ABBOTT MEDICAL2019-05-01
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