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ABBOTT MEDICAL

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

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RecordFirmDate
Allure, Allure Quadra, Quadra Allure MP (P030035/S174)ABBOTT MEDICAL2018-10-24
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S032)ABBOTT MEDICAL2018-10-24
IsoFlex Optim (P960030/S060)ABBOTT MEDICAL2018-10-24
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead (P960013/S101)ABBOTT MEDICAL2018-10-24
Microny (P970013/S079)ABBOTT MEDICAL2018-10-24
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet CRT Leads (P030054/S360)ABBOTT MEDICAL2018-10-24
Fortify, Fortify Assura, Ellipse (P910023/S412)ABBOTT MEDICAL2018-10-24
HeartMate 3 Left Ventricular Assist System (P160054/S008)ABBOTT MEDICAL2018-10-18
QuickFlex u 1258T LV Lead (P030054/S359)ABBOTT MEDICAL2018-10-09
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S013)ABBOTT MEDICAL2018-10-05
Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters (P140009/S040)ABBOTT MEDICAL2018-10-03
Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters (P010032/S143)ABBOTT MEDICAL2018-10-03
Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S036)ABBOTT MEDICAL2018-10-01
Assurity / Assurity+ / Endurity (P880086/S302)ABBOTT MEDICAL2018-10-01
Assurity MRI and Endurity MRI (P140033/S037)ABBOTT MEDICAL2018-10-01
Allura, Allure Quadra/ Quadra Allure MP (P030035/S173)ABBOTT MEDICAL2018-10-01
HV Steroid Eluting Cardiac Leads (P950022/S107)ABBOTT MEDICAL2018-09-24
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S071)ABBOTT MEDICAL2018-09-20
Proclaim DRG IPG (P150004/S025)ABBOTT MEDICAL2018-09-19
DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim (P150004/S024)ABBOTT MEDICAL2018-09-14
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS) (P160054/S011)ABBOTT MEDICAL2018-09-12
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S012)ABBOTT MEDICAL2018-09-12
Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT ) (P100029/S035)ABBOTT MEDICAL2018-09-10
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S005)ABBOTT MEDICAL2018-08-24
Anthem; Allure, Allure Quadra; Quadra Allure MP (P030035/S172)ABBOTT MEDICAL2018-08-14
Assurity MRI; Endurity MRI; Tendril MRI (P140033/S036)ABBOTT MEDICAL2018-08-14
Current+; Fortify; Fortify Assura; Fortify Assura (MR Conditional); Ellipse; Ellipse (MR Conditional) (P910023/S411)ABBOTT MEDICAL2018-08-14
CardioMEMS HF System (P100045/S031)ABBOTT MEDICAL2018-08-14
Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass (P030054/S358)ABBOTT MEDICAL2018-08-14
Microny (P970013/S078)ABBOTT MEDICAL2018-08-14
Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL (P880086/S301)ABBOTT MEDICAL2018-08-14
MitraClip System (NT) (P100009/S026)ABBOTT MEDICAL2018-08-13
DBS System 4CH Lead / DBS System 8CH Directional Lead (P140009/S036)ABBOTT MEDICAL2018-08-10
HeartMate 3™ Left Ventricular Assist System pump rotor sub-assembly (P160054/S004)ABBOTT MEDICAL2018-08-06
CardioMEMS HF System (P100045/S030)ABBOTT MEDICAL2018-07-24
SJM Infinity Deep Brain Stimulation (DBS) Neurostimulation System (P140009/S037)ABBOTT MEDICAL2018-07-19
Tendril MRI (P140033/S035)ABBOTT MEDICAL2018-07-19
QuickFlex u and Quartet (P030054/S357)ABBOTT MEDICAL2018-07-19
Durata and Optisure (P950022/S120)ABBOTT MEDICAL2018-07-19
Tendril SDX, OptiSense, Tendril STS and Tendril ST (P960013/S100)ABBOTT MEDICAL2018-07-19
IsoFlex (P960030/S059)ABBOTT MEDICAL2018-07-19
Spinal Cord Stimulation (SCS) External Programmer Apps (P010032/S141)ABBOTT MEDICAL2018-07-19
Proclaim Dorsal Root Ganglion (DRG) External Programmer Apps (P150004/S020)ABBOTT MEDICAL2018-07-19
CardioMEMS HF System (P100045/S029)ABBOTT MEDICAL2018-07-10
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S007)ABBOTT MEDICAL2018-07-05
MitraClip Clip Delivery System (NTR and XTR) (P100009/S027)ABBOTT MEDICAL2018-06-29
Durata and Optisure Leads (P950022/S119)ABBOTT MEDICAL2018-06-27
Allure, Allure Quadra, Quadra Allure MP, and Anthem (P030035/S170)ABBOTT MEDICAL2018-06-15
Ellipse, Fortify, Fortify Assura and Quadra Assura MP (P910023/S409)ABBOTT MEDICAL2018-06-15
Quadra Assura, Unify, Unify Assura and Unify Quadra (P030054/S354)ABBOTT MEDICAL2018-06-15
Assurity, Assurity +, Endurity, Accent and Victory XL (P880086/S300)ABBOTT MEDICAL2018-06-15
Assurity MRI and Endurity MRI (P140033/S032)ABBOTT MEDICAL2018-06-15
FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) (P110016/S057)ABBOTT MEDICAL2018-06-13
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT ) (P100029/S034)ABBOTT MEDICAL2018-06-12
St.Jude Medical Biocor, Epic and Epic Supra Valves (P040021/S036)ABBOTT MEDICAL2018-06-12
HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S009)ABBOTT MEDICAL2018-06-01
HeartMate ll Left Ventricular Assist System (LVAS) (P060040/S070)ABBOTT MEDICAL2018-06-01
HeartMate 3™ Left Ventricular Assist System (P160054/S006)ABBOTT MEDICAL2018-05-31
Tendril MRI (P140033/S030)ABBOTT MEDICAL2018-05-29
MitraClip System (NTR and XTR) (P100009/S025)ABBOTT MEDICAL2018-05-23
DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit (P150004/S022)ABBOTT MEDICAL2018-05-19
HeartMate 3™ Left Ventricular Assist System (P160054/S010)ABBOTT MEDICAL2018-05-18
Allure, Allure Quadra, Quadra Allure MP (P030035/S169)ABBOTT MEDICAL2018-05-03
Assurity, Assurity +, Endurity (P880086/S298)ABBOTT MEDICAL2018-05-03
Endurity MRI, Assurity MRI (P140033/S029)ABBOTT MEDICAL2018-05-03
THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S060)ABBOTT MEDICAL2018-04-26
Assurity MRI, Endurity MRI (P140033/S028)ABBOTT MEDICAL2018-04-25
Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF (P030035/S168)ABBOTT MEDICAL2018-04-25
Assurity, Assurity +, Endurity, Endurity Core (P880086/S297)ABBOTT MEDICAL2018-04-25
Ellipse VR, Ellipse DR, Fortify, Fortify Assura (P910023/S408)ABBOTT MEDICAL2018-04-25
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S353)ABBOTT MEDICAL2018-04-25
Biocor Valve, Epic Valve, Epic Supra Valve (P040021/S035)ABBOTT MEDICAL2018-04-19
Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S033)ABBOTT MEDICAL2018-04-19
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+family of ICDS (P910023/S400)ABBOTT MEDICAL2018-04-11
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S344)ABBOTT MEDICAL2018-04-11
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S293)ABBOTT MEDICAL2018-04-11
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S164)ABBOTT MEDICAL2018-04-11
Assurity MRI Endurity MRI family of Pacemakers (P140033/S022)ABBOTT MEDICAL2018-04-11
Microny family of Pacemakers (P970013/S076)ABBOTT MEDICAL2018-04-11
FlexAbility Catheter, Sensor Enabled (P110016/S056)ABBOTT MEDICAL2018-04-09
CardioMEMS HF System (P100045/S023)ABBOTT MEDICAL2018-04-04
Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, CD3257-40Q, CD3357-40, CD3357-4 (P030054/S351)ABBOTT MEDICAL2018-04-04
Fortify Models CD1231-40, CD1231-40Q, CD2231-40, CD2231-40Q; Fortify Assura Models CD1257-40, CD1257-40Q, CD2257-40, CD2 (P910023/S406)ABBOTT MEDICAL2018-04-04
Forify, Fortify Assura (P910023/S407)ABBOTT MEDICAL2018-04-03
Unify, Unify Quadra, Unify Assura, Quadra Assura and Quadra Assura MP (P030054/S352)ABBOTT MEDICAL2018-04-03
Tendril SDX/ST/STS and Optisense Leads (LV Active) (P960013/S090)ABBOTT MEDICAL2018-04-02
QuickFlex u and Quartet leads (P030054/S323)ABBOTT MEDICAL2018-04-02
Tendril MRI Leads (MRI) (P140033/S002)ABBOTT MEDICAL2018-04-02
Durata and Optisure Leads (HV Active and Passive) (P950022/S102)ABBOTT MEDICAL2018-04-02
IsoFlex Optim Leads (lV Passive) (P960030/S052)ABBOTT MEDICAL2018-04-02
Trifecta Valve/Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S032)ABBOTT MEDICAL2018-03-29
Durata and Optisre Family of High Voltage Leads (P950022/S116)ABBOTT MEDICAL2018-03-27
FlexAbility Ablation Catheter, Sensor Enabled (P110016/S050)ABBOTT MEDICAL2018-03-22
QuickFlex u, Quartet (P030054/S350)ABBOTT MEDICAL2018-03-21
IsoFlex (P960030/S058)ABBOTT MEDICAL2018-03-21
Tendril SDX, OptiSense, Tendril STS, Tendril ST (P960013/S097)ABBOTT MEDICAL2018-03-21
Durata, Optisure (P950022/S118)ABBOTT MEDICAL2018-03-21
OptiSense; Tendril STS, Tendril SDX, Tendril ST (P960013/S096)ABBOTT MEDICAL2018-03-20
Tendril (P140033/S027)ABBOTT MEDICAL2018-03-20
QuickFlex, Quartet (P030054/S349)ABBOTT MEDICAL2018-03-20
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