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ABBOTT MEDICAL

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

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RecordFirmDate
Allure™ PM3120; Allure Quadra™ RF PM3242; Allure Quadra™ PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; (P030035/S210)ABBOTT MEDICAL2025-06-18
Aveir LSP112V, LSP201A, LSP202V (P150035/S027)ABBOTT MEDICAL2025-06-18
Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 (P910023/S480)ABBOTT MEDICAL2025-06-18
IsoFlex Optim Lead 1944, 1948 (P960030/S082)ABBOTT MEDICAL2025-06-18
Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C (P030054/S437)ABBOTT MEDICAL2025-06-18
Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, (P950022/S149)ABBOTT MEDICAL2025-06-18
P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, (P880086/S344)ABBOTT MEDICAL2025-06-18
OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead (P960013/S130)ABBOTT MEDICAL2025-06-18
Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI (P140033/S099)ABBOTT MEDICAL2025-06-18
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S477)ABBOTT MEDICAL2025-06-17
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S342)ABBOTT MEDICAL2025-06-17
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S096)ABBOTT MEDICAL2025-06-17
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S208)ABBOTT MEDICAL2025-06-17
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S433)ABBOTT MEDICAL2025-06-17
Aveir Leadless System (P150035/S023)ABBOTT MEDICAL2025-06-17
Microny family of Pacemakers (P970013/S097)ABBOTT MEDICAL2025-06-17
Liberta RC Deep Brain Stimulation Implantable Pulse Generator (P140009/S116)ABBOTT MEDICAL2025-06-09
Eterna Spinal Cord Stimulation Implantable Pulse Generator (P010032/S234)ABBOTT MEDICAL2025-06-09
HeartMate II™ Left Ventricular Assist System (P060040/S116)ABBOTT MEDICAL2025-06-04
HeartMate 3™ Left Ventricular Assist System (P160054/S101)ABBOTT MEDICAL2025-06-04
HeartMate 3 Left Ventricular Assist System (P160054/S100)ABBOTT MEDICAL2025-05-23
Tendyne Transcatheter Mitral Valve System (P240042)ABBOTT MEDICAL2025-05-23
HeartMate II Left Ventricular Assist System (P060040/S115)ABBOTT MEDICAL2025-05-23
Endurity MRI, Assurity MRI (P140033/S097)ABBOTT MEDICAL2025-05-22
Tendril STS, Optisense (P960013/S128)ABBOTT MEDICAL2025-05-22
Durata, Optisure (P950022/S147)ABBOTT MEDICAL2025-05-22
Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR (P880086/S343)ABBOTT MEDICAL2025-05-22
Avant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro (P030054/S434)ABBOTT MEDICAL2025-05-22
IsoFlex (P960030/S079)ABBOTT MEDICAL2025-05-22
Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR, Ellipse VR, Ellips (P910023/S478)ABBOTT MEDICAL2025-05-22
Aveir VR (P150035/S025)ABBOTT MEDICAL2025-05-22
Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF (P030035/S209)ABBOTT MEDICAL2025-05-22
Microny II SR+ (P970013/S098)ABBOTT MEDICAL2025-05-22
HeartMate 3™ Left Ventricular Assist System (P160054/S106)ABBOTT MEDICAL2025-05-21
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S119)ABBOTT MEDICAL2025-05-21
MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (P100009/S074)ABBOTT MEDICAL2025-05-18
TriClip G4 Delivery System;TriClip G5 Delivery System (P230007/S012)ABBOTT MEDICAL2025-05-18
SCS System (P010032/S235)ABBOTT MEDICAL2025-05-16
DBS System (P140009/S117)ABBOTT MEDICAL2025-05-16
CardioMEMS HF System (P100045/S081)ABBOTT MEDICAL2025-05-15
MITRACLIP DELIVERY SYSTEM (P100009/S071)ABBOTT MEDICAL2025-05-09
TriClip G4 System (P230007/S010)ABBOTT MEDICAL2025-05-09
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S105)ABBOTT MEDICAL2025-05-08
HeartMate II™ Left Ventricular Assist System (P060040/S118)ABBOTT MEDICAL2025-05-08
Navitor Transcatheter Aortic Valve Implantation System (P190023/S025)ABBOTT MEDICAL2025-05-07
MitraClip G4 Clip Delivery System (P100009/S072)ABBOTT MEDICAL2025-05-06
FlexAbility™ Ablation Catheter, Sensor Enabled™ (P110016/S090)ABBOTT MEDICAL2025-05-06
Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S009)ABBOTT MEDICAL2025-04-22
MitraClip Systems (P100009/S073)ABBOTT MEDICAL2025-04-18
TriClip Systems (P230007/S011)ABBOTT MEDICAL2025-04-18
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S010)ABBOTT MEDICAL2025-04-16
Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant (P910023/S476)ABBOTT MEDICAL2025-04-15
Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra (P030054/S432)ABBOTT MEDICAL2025-04-15
HeartMate II Left Ventricular Assist System (P060040/S117)ABBOTT MEDICAL2025-04-14
HeartMate 3 Left Ventricular Assist System (P160054/S103)ABBOTT MEDICAL2025-04-14
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S018)ABBOTT MEDICAL2025-04-11
FlexAbility™ Ablation Catheter; FlexAbility™ Ablation Catheter, Sensor Enabled™ (P110016/S088)ABBOTT MEDICAL2025-04-10
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S017)ABBOTT MEDICAL2025-04-10
HeartMate 3™ Left Ventricular Assist System (P160054/S102)ABBOTT MEDICAL2025-04-07
Aveir VR Leadless System (P150035/S022)ABBOTT MEDICAL2025-04-03
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S198)ABBOTT MEDICAL2025-04-01
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent (P910023/S461)ABBOTT MEDICAL2025-04-01
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S084)ABBOTT MEDICAL2025-04-01
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S416)ABBOTT MEDICAL2025-04-01
Microny family of Pacemakers (P970013/S094)ABBOTT MEDICAL2025-04-01
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S333)ABBOTT MEDICAL2025-04-01
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S011)ABBOTT MEDICAL2025-03-27
Amplatzer™ Septal Occluder; Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P000039/S082)ABBOTT MEDICAL2025-03-27
HeartMate 3™ Left Ventricular Assist System (P160054/S099)ABBOTT MEDICAL2025-03-18
BRIO NEUROSTIMULATION SYSTEM (P140009/S115)ABBOTT MEDICAL2025-03-13
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S233)ABBOTT MEDICAL2025-03-13
Spinal Cord Stimulation (SCS) External Pulse Generator (EPG) (P010032/S231)ABBOTT MEDICAL2025-03-12
SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim (P150004/S074)ABBOTT MEDICAL2025-03-12
Dorsal Root Ganglion (DRG) External Pulse Generator (EPG) (P150004/S082)ABBOTT MEDICAL2025-03-12
HeartMate 3™ Left Ventricular Assist System (P160054/S098)ABBOTT MEDICAL2025-03-12
Deep Brain Stimulation (DBS) External Pulse Generator (EPG) (P140009/S113)ABBOTT MEDICAL2025-03-12
Amplatzer Septal Occluder (P000039/S081)ABBOTT MEDICAL2025-03-05
Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S010)ABBOTT MEDICAL2025-03-05
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S011)ABBOTT MEDICAL2025-03-05
HeartMate 3 (HM3) Left Ventricular Assist System (P160054/S097)ABBOTT MEDICAL2025-02-26
HeartMate II (HMII) Left Ventricular Assist System (P060040/S114)ABBOTT MEDICAL2025-02-26
Infinity Deep Brain Stimulation (DBS) IPG; Liberta RC DBS IPG (P140009/S114)ABBOTT MEDICAL2025-02-21
Proclaim™ Dorsal Root Ganglion (DRG) IPG (P150004/S083)ABBOTT MEDICAL2025-02-21
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG (P010032/S232)ABBOTT MEDICAL2025-02-21
Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield (P810002/S124)ABBOTT MEDICAL2025-02-20
HeartMate 3 Left Ventricular Assist System (P160054/S096)ABBOTT MEDICAL2025-02-18
HeartMate II Left Ventricular Assist System (P060040/S113)ABBOTT MEDICAL2025-02-18
HeartMate 3™ Left Ventricular Assist System (P160054/S095)ABBOTT MEDICAL2025-02-13
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S431)ABBOTT MEDICAL2025-02-13
Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify (P910023/S475)ABBOTT MEDICAL2025-02-13
MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System (P100009/S070)ABBOTT MEDICAL2025-02-10
TriClip G4 System, TriClip G5 Delivery System (P230007/S009)ABBOTT MEDICAL2025-02-10
CardioMEMS HF System (P100045/S077)ABBOTT MEDICAL2025-02-06
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S205)ABBOTT MEDICAL2025-02-05
Tendril STS, UltiPace (P960013/S127)ABBOTT MEDICAL2025-02-05
Durata, Optisure (P950022/S146)ABBOTT MEDICAL2025-02-05
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S470)ABBOTT MEDICAL2025-02-05
Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers (P140033/S093)ABBOTT MEDICAL2025-02-05
Aveir Leadless System (P150035/S017)ABBOTT MEDICAL2025-02-05
Microny family of Pacemakers (P970013/S096)ABBOTT MEDICAL2025-02-05
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