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ABBOTT MEDICAL

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

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RecordFirmDate
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S437)ABBOTT MEDICAL2021-06-28
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S392)ABBOTT MEDICAL2021-06-28
FlexAbility Ablation Catheter (FlexAbility) and FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) (P110016/S077)ABBOTT MEDICAL2021-06-25
NextGen DRG Lead Kit and Accessories (P150004/S044)ABBOTT MEDICAL2021-06-22
HeartMate 3 Left Ventricular Assist System (P160054/S037)ABBOTT MEDICAL2021-06-10
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S175)ABBOTT MEDICAL2021-06-08
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S069)ABBOTT MEDICAL2021-06-08
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S047)ABBOTT MEDICAL2021-06-08
MitraClip NTR/XTR Delivery System (P100009/S042)ABBOTT MEDICAL2021-06-03
Epic and Epic Supra Tissue Heart Valves (P040021/S046)ABBOTT MEDICAL2021-05-28
FlexAbility and FlexAbility SE Ablation Catheter (P110016/S076)ABBOTT MEDICAL2021-05-18
Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter (P110016/S075)ABBOTT MEDICAL2021-05-04
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S036)ABBOTT MEDICAL2021-04-28
Deep Brain Stimulation (DBS) System (P140009/S068)ABBOTT MEDICAL2021-04-23
Dorsal Root Ganglion (DRG) System (P150004/S046)ABBOTT MEDICAL2021-04-23
Spinal Cord Stimulation (SCS) System (P010032/S174)ABBOTT MEDICAL2021-04-23
CardioMEMS I3 Patient Electronics System (PES) (P100045/S051)ABBOTT MEDICAL2021-04-22
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional) (P910023/S436)ABBOTT MEDICAL2021-04-09
Microny (P970013/S086)ABBOTT MEDICAL2021-04-09
Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional) (P960013/S117)ABBOTT MEDICAL2021-04-09
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL (P880086/S318)ABBOTT MEDICAL2021-04-09
Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional) (P950022/S138)ABBOTT MEDICAL2021-04-09
Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional) (P030035/S185)ABBOTT MEDICAL2021-04-09
Assurity MRI, Endurity MRI and Tendril MRI (P140033/S066)ABBOTT MEDICAL2021-04-09
IsoFlex Optim (P960030/S074)ABBOTT MEDICAL2021-04-09
Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S391)ABBOTT MEDICAL2021-04-09
Cardiomems HF System (P100045/S050)ABBOTT MEDICAL2021-04-06
Therapy Cool Path Duo and Therapy Cool Flex (P110016/S074)ABBOTT MEDICAL2021-03-24
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S035)ABBOTT MEDICAL2021-03-23
HeartMate 3 Left Ventricular Assist System (P160054/S034)ABBOTT MEDICAL2021-03-21
HeartMate II Left Ventricular Assist System (P060040/S079)ABBOTT MEDICAL2021-03-21
QuickFlex µ and Quartet (P030054/S390)ABBOTT MEDICAL2021-03-18
IsoFlex (P960030/S073)ABBOTT MEDICAL2021-03-18
Medical Mechanical Heart Valve (P810002/S110)ABBOTT MEDICAL2021-03-17
CardioMEMS HF System (P100045/S047)ABBOTT MEDICAL2021-03-12
Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther (P110016/S073)ABBOTT MEDICAL2021-03-12
MitraClip NT Clip Delivery System, MitraClip XT Clip Delivery System, and MitraClip G4 Clip Delivery System (P100009/S039)ABBOTT MEDICAL2021-03-09
CardioMEMS HF System (P100045/S048)ABBOTT MEDICAL2021-03-09
Infinity family of DBS IPGs (P140009/S064)ABBOTT MEDICAL2021-03-05
Proclaim DRG IPG (P150004/S043)ABBOTT MEDICAL2021-03-05
Deep Brain Stimulation Multilead Trial Cable (DBS MLTC) (P140009/S066)ABBOTT MEDICAL2021-03-05
Proclaim family of SCS IPGs (P010032/S168)ABBOTT MEDICAL2021-03-05
Spinal Cord Stimulation (SCS) System (P010032/S169)ABBOTT MEDICAL2021-02-24
Deep Brain Stimulation (DBS) System (P140009/S065)ABBOTT MEDICAL2021-02-24
Internal Leads Extensions and 8 Chanel Adapters (P140009/S053)ABBOTT MEDICAL2021-02-22
Paddle Leads (P010032/S157)ABBOTT MEDICAL2021-02-22
MitraClip Clip System (P100009/S038)ABBOTT MEDICAL2021-02-22
Genesis Neurostimulation System (P010032/S170)ABBOTT MEDICAL2021-02-03
Axium Neurostimulator System (P150004/S040)ABBOTT MEDICAL2021-01-21
Proclaim SCS Neurostimulator System (P150004/S041)ABBOTT MEDICAL2021-01-19
Proclaim SCS Neurostimulation System (P140009/S062)ABBOTT MEDICAL2021-01-19
Proclaim SCS Neurostimulation System (P010032/S166)ABBOTT MEDICAL2021-01-19
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S033)ABBOTT MEDICAL2021-01-07
FlexAbility Ablation Catheter, Sensor Enabled (P110016/S072)ABBOTT MEDICAL2021-01-06
CardioMEMS HF System (P100045/S046)ABBOTT MEDICAL2020-12-22
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S031)ABBOTT MEDICAL2020-12-17
Assurity MRI and Endurity MRI (P140033/S060)ABBOTT MEDICAL2020-12-16
Tendril STS (P960013/S114)ABBOTT MEDICAL2020-12-16
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S316)ABBOTT MEDICAL2020-12-15
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S183)ABBOTT MEDICAL2020-12-15
IsoFlex Optim, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960030/S072)ABBOTT MEDICAL2020-12-15
Tendril DX Endocardial Pacing Leads (P960013/S116)ABBOTT MEDICAL2020-12-15
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S137)ABBOTT MEDICAL2020-12-15
Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S388)ABBOTT MEDICAL2020-12-15
Assurity MRI, Endurity MRI, Tendril MRI (P140033/S064)ABBOTT MEDICAL2020-12-15
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional), Avant VR, Avant D (P910023/S434)ABBOTT MEDICAL2020-12-15
Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves (P040021/S045)ABBOTT MEDICAL2020-12-10
Cardiac Resynchronization Therapy (CRT) (P030054/S387)ABBOTT MEDICAL2020-11-20
Tendril MRI (P140033/S062)ABBOTT MEDICAL2020-11-20
Protege/Prodigy/Proclaim XR family of SCS IPGs, SCS EPG and SCS Percutaneous Permanent and Trial leads (P010032/S165)ABBOTT MEDICAL2020-11-15
Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP and Therap (P110016/S070)ABBOTT MEDICAL2020-11-02
Assurity, Assurity+, and Endurity (P880086/S314)ABBOTT MEDICAL2020-10-29
Assurity MRI and Endurity MRI (P140033/S061)ABBOTT MEDICAL2020-10-29
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S382)ABBOTT MEDICAL2020-10-28
Fortify, Fortify Assura, and Ellipse (P910023/S430)ABBOTT MEDICAL2020-10-28
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S078)ABBOTT MEDICAL2020-10-27
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional) (P910023/S433)ABBOTT MEDICAL2020-10-26
Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960013/S115)ABBOTT MEDICAL2020-10-26
Assurity MRI, Endurity MRI, Tendril MRI (P140033/S063)ABBOTT MEDICAL2020-10-26
Microny (P970013/S084)ABBOTT MEDICAL2020-10-26
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S315)ABBOTT MEDICAL2020-10-26
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S136)ABBOTT MEDICAL2020-10-26
Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S386)ABBOTT MEDICAL2020-10-26
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S182)ABBOTT MEDICAL2020-10-26
IsoFlex Optim (P960030/S071)ABBOTT MEDICAL2020-10-26
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S032)ABBOTT MEDICAL2020-10-20
Durata, Optisure (P950022/S135)ABBOTT MEDICAL2020-10-16
Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo Ablation Catheter, Safire Duo Ablation Catheter, MediGuide En (P110016/S071)ABBOTT MEDICAL2020-10-16
Quickflex µ, Quartet (P030054/S384)ABBOTT MEDICAL2020-10-16
Isoflex (P960030/S070)ABBOTT MEDICAL2020-10-16
Biocor, Biocor Supra, Epic, Epic Supra (P040021/S044)ABBOTT MEDICAL2020-10-14
Trifecta and Trifecta Valve with Glide Technology (P100029/S043)ABBOTT MEDICAL2020-10-14
AMPLATZER PFO Occluder (P120021/S016)ABBOTT MEDICAL2020-10-06
AMPLATZER Duct Occluder (P020024/S061)ABBOTT MEDICAL2020-10-06
AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal (Cribriform) Occluder (P000039/S071)ABBOTT MEDICAL2020-10-06
AMPLATZER Muscular VSD Occluder (P040040/S041)ABBOTT MEDICAL2020-10-06
Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and (P910023/S432)ABBOTT MEDICAL2020-09-23
Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D (P030054/S385)ABBOTT MEDICAL2020-09-23
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/ II+ (P030054/S380)ABBOTT MEDICAL2020-09-22
Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne (P910023/S428)ABBOTT MEDICAL2020-09-22
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