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ABBOTT MEDICAL

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

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RecordFirmDate
HeartMate II Left Ventricular Assist System (P060040/S091)ABBOTT MEDICAL2023-09-29
Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P010032/S204)ABBOTT MEDICAL2023-09-29
Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P140009/S089)ABBOTT MEDICAL2023-09-29
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P150004/S067)ABBOTT MEDICAL2023-09-29
HeartMate 3 Left Ventricular Assist System (P160054/S053)ABBOTT MEDICAL2023-09-29
HeartMate 3™ Left Ventricular Assist System (P160054/S059)ABBOTT MEDICAL2023-09-27
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S203)ABBOTT MEDICAL2023-09-22
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S066)ABBOTT MEDICAL2023-09-22
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S088)ABBOTT MEDICAL2023-09-22
Accent, Assurity, Assurity+ , Zenus, Zenex, Endurity Family of Pacemakers (P880086/S330)ABBOTT MEDICAL2023-09-20
Assurity MRI, Endurity MRI, Accent MRI, Zenus MRI and Zenex MRI (P140033/S081)ABBOTT MEDICAL2023-09-20
Fortify, Fortify Assura, Ellipse Family of ICD Devices (P910023/S456)ABBOTT MEDICAL2023-09-20
Anthem, Allure, Quadra Allure and Allure Quadra Family of CRT-Ps (P030035/S196)ABBOTT MEDICAL2023-09-20
Quadra Assura, Unify, Unify Assura and Unify Quadra Family of CRT-D (P030054/S411)ABBOTT MEDICAL2023-09-20
Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste (P190023/S013)ABBOTT MEDICAL2023-09-15
HeartMate 3 Left Ventricular Assist System (P160054/S058)ABBOTT MEDICAL2023-09-12
HeartMate 3 Left Ventricular Assist System (P160054/S057)ABBOTT MEDICAL2023-09-07
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S007)ABBOTT MEDICAL2023-09-07
TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) (P220013/S006)ABBOTT MEDICAL2023-09-07
CardioMEMS HF System (P100045/S069)ABBOTT MEDICAL2023-09-06
MitraClip™ G4 Clip Delivery System (P100009/S057)ABBOTT MEDICAL2023-08-30
Infinity Deep Brain Stimulation (DBS) System (P140009/S086)ABBOTT MEDICAL2023-08-25
Aveir™ VR and DR Leadless Pacemakers (P150035/S005)ABBOTT MEDICAL2023-08-24
MitraClip™ Clip Delivery System (P100009/S052)ABBOTT MEDICAL2023-08-23
FlexAbility™ Ablation Catheter, FlexAbility™ Ablation Catheter, Sensor Enabled™ (P110016/S085)ABBOTT MEDICAL2023-08-17
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S004)ABBOTT MEDICAL2023-08-17
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S003)ABBOTT MEDICAL2023-08-16
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S005)ABBOTT MEDICAL2023-08-11
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S201)ABBOTT MEDICAL2023-08-09
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S064)ABBOTT MEDICAL2023-08-09
QuickFlex µ, Quartet (P030054/S410)ABBOTT MEDICAL2023-08-08
CardioMEMS Hospital System (P100045/S066)ABBOTT MEDICAL2023-07-28
Spinal Cord Stimulation (SCS) System (P010032/S195)ABBOTT MEDICAL2023-07-27
Infinity Deep Brain Stimulation (DBS) System (P140009/S081)ABBOTT MEDICAL2023-07-27
CardioMEMS HF System (P100045/S068)ABBOTT MEDICAL2023-07-26
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P150004/S062)ABBOTT MEDICAL2023-07-21
Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P010032/S199)ABBOTT MEDICAL2023-07-21
Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P140009/S085)ABBOTT MEDICAL2023-07-21
Neutrino™ NxT HF, Avant™ HF, Gallant ™ HF, Entrant™ HF (P030054/S409)ABBOTT MEDICAL2023-07-19
CardioMEMSTM HF System (P100045/S067)ABBOTT MEDICAL2023-07-19
HeartMate 3 Left Ventricular Assist System (P160054/S051)ABBOTT MEDICAL2023-07-03
MitraClip™ Clip Delivery System (P100009/S056)ABBOTT MEDICAL2023-06-29
Aveir DR Leadless System (P150035/S003)ABBOTT MEDICAL2023-06-29
HeartMate 3™ Left Ventricular Assist System (P160054/S055)ABBOTT MEDICAL2023-06-22
Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR (P910023/S454)ABBOTT MEDICAL2023-06-15
Avant™ HF, Neutrino™ NxT HF, Gallant™ HF, Entrant™ HF (P030054/S407)ABBOTT MEDICAL2023-06-15
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) (P150004/S061)ABBOTT MEDICAL2023-06-02
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S083)ABBOTT MEDICAL2023-06-02
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S198)ABBOTT MEDICAL2023-06-02
Endurity MRI, Assurity MRI (P140033/S080)ABBOTT MEDICAL2023-05-23
Accent, Accent MRI, Assurity, Assurity+, Endurity ,Endurity Core (P880086/S329)ABBOTT MEDICAL2023-05-23
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S195)ABBOTT MEDICAL2023-05-23
TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C (P220013)ABBOTT MEDICAL2023-05-18
Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads (P960013/S122)ABBOTT MEDICAL2023-05-11
Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems (P010032/S191)ABBOTT MEDICAL2023-05-10
Navitor Transcatheter Aortic Heart Valve (P190023/S015)ABBOTT MEDICAL2023-05-10
Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt (P010032/S193)ABBOTT MEDICAL2023-05-05
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S197)ABBOTT MEDICAL2023-05-04
Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S060)ABBOTT MEDICAL2023-05-04
MitraClip™ Clip Delivery System (P100009/S054)ABBOTT MEDICAL2023-05-03
FlexAbility Ablation Catheter, FlexAbility SE (P110016/S083)ABBOTT MEDICAL2023-05-02
Amplatzer Amulet (ACP2) (P200049/S005)ABBOTT MEDICAL2023-05-02
Amplatzer Septal Occluder (ASO/ASD) (P000039/S077)ABBOTT MEDICAL2023-05-02
Assurity, Assurity +, Endurity, Endurity Core (P880086/S328)ABBOTT MEDICAL2023-05-01
Assurity MRI, Endurity MRI (P140033/S079)ABBOTT MEDICAL2023-05-01
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP, Quadra Allure MP RF (P030035/S194)ABBOTT MEDICAL2023-05-01
Ellipse DR, Ellipse VR (P910023/S453)ABBOTT MEDICAL2023-05-01
HeartMate II™ Left Ventricular Assist System (LVAS) (P060040/S092)ABBOTT MEDICAL2023-04-29
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S054)ABBOTT MEDICAL2023-04-29
CardioMEMS HF System (P100045/S065)ABBOTT MEDICAL2023-04-28
Spinal Cord Stimulation (SCS) System (P010032/S192)ABBOTT MEDICAL2023-04-28
Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System (P190023/S014)ABBOTT MEDICAL2023-04-26
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S326)ABBOTT MEDICAL2023-04-14
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S405)ABBOTT MEDICAL2023-04-14
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S192)ABBOTT MEDICAL2023-04-14
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and (P910023/S451)ABBOTT MEDICAL2023-04-14
Aveir VR Leadless Pacemaker (P150035/S004)ABBOTT MEDICAL2023-04-14
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S077)ABBOTT MEDICAL2023-04-14
Microny family of Pacemakers (P970013/S092)ABBOTT MEDICAL2023-04-14
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S082)ABBOTT MEDICAL2023-04-07
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S059)ABBOTT MEDICAL2023-04-07
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S196)ABBOTT MEDICAL2023-04-07
Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ) (P810002/S118)ABBOTT MEDICAL2023-03-31
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System (P100009/S053)ABBOTT MEDICAL2023-03-30
Epic™ Max Tissue Heart Valves (P040021/S052)ABBOTT MEDICAL2023-03-28
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S117)ABBOTT MEDICAL2023-03-28
Amplatzer Piccolo™ Occluder (P020024/S067)ABBOTT MEDICAL2023-03-27
HeartMate II Left Ventricular Assist System (P060040/S090)ABBOTT MEDICAL2023-03-21
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S048)ABBOTT MEDICAL2023-03-07
FlexAbility™ Ablation Catheter, Sensor Enabled™ (P110016/S082)ABBOTT MEDICAL2023-02-24
Ellipse, Fortify, Fortify Assura, Quadra Assura MP (P910023/S449)ABBOTT MEDICAL2023-02-21
Quadra Assura, Unify, Unify Assura, Unify Quadra (P030054/S403)ABBOTT MEDICAL2023-02-21
HeartMate 3™ Left Ventricular Assist System (P160054/S052)ABBOTT MEDICAL2023-02-16
Allure, Allure Quadra, Quadra Allure, Quadra Allure MP (P030035/S193)ABBOTT MEDICAL2023-02-10
Fortify, Fortify Assura, Ellipse, Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avan (P910023/S450)ABBOTT MEDICAL2023-02-10
Unify ,Unify Assura, Quadra Assura, Quadra Assura MP, Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Neutrino NxT (P030054/S404)ABBOTT MEDICAL2023-02-10
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S452)ABBOTT MEDICAL2023-02-10
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S406)ABBOTT MEDICAL2023-02-10
Assurity MRI, Endurity MRI, (P140033/S078)ABBOTT MEDICAL2023-02-10
Assurity, Assurity+, Endurity (P880086/S327)ABBOTT MEDICAL2023-02-10
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