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ABBOTT MEDICAL

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

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RecordFirmDate
Portico™ (P190023/S012)ABBOTT MEDICAL2023-02-07
MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System (P100009/S051)ABBOTT MEDICAL2023-01-31
Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield™ graft technology (C (P810002/S116)ABBOTT MEDICAL2023-01-27
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems (P010032/S189)ABBOTT MEDICAL2023-01-24
Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste (P190023/S002)ABBOTT MEDICAL2023-01-13
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S050)ABBOTT MEDICAL2023-01-10
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S089)ABBOTT MEDICAL2023-01-10
CardioMEMS HF System (P100045/S064)ABBOTT MEDICAL2023-01-06
Eterna SCS IPG, Charger, Patient Controller Application, Clinician Programmer Application (P010032/S186)ABBOTT MEDICAL2022-12-16
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System (P100009/S050)ABBOTT MEDICAL2022-12-15
Trifecta (P100029/S049)ABBOTT MEDICAL2022-12-14
Biocor/Epic (P040021/S051)ABBOTT MEDICAL2022-12-14
FlexAbility™ Ablation Catheter, Sensor Enabled™ (P110016/S080)ABBOTT MEDICAL2022-12-14
Portico™ (P190023/S011)ABBOTT MEDICAL2022-12-14
FlexAbility Ablation Catheter / FlexAbility Ablation Catheter, Sensor Enabled (SE) (P110016/S081)ABBOTT MEDICAL2022-12-08
IsoFlex (P960030/S077)ABBOTT MEDICAL2022-12-07
Assurity MRI, Endurity MRI (P140033/S076)ABBOTT MEDICAL2022-12-07
Trifecta™ Valve with Glide Technology™ (P100029/S048)ABBOTT MEDICAL2022-12-06
Trifecta™ Valve with Glide Technology™ (P100029/S047)ABBOTT MEDICAL2022-11-29
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System (P100009/S049)ABBOTT MEDICAL2022-11-20
HeartMate II Left Ventricular Assist System (P060040/S088)ABBOTT MEDICAL2022-11-10
PorticoTM Transcatheter Aortic Valve Implantation System (P190023/S010)ABBOTT MEDICAL2022-11-09
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S080)ABBOTT MEDICAL2022-10-28
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S194)ABBOTT MEDICAL2022-10-28
Deep Brain Stimulation (DBS) System (P140009/S079)ABBOTT MEDICAL2022-10-17
MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System (P100009/S048)ABBOTT MEDICAL2022-10-17
HeartMate II™ Left Ventricular Assist System (LVAS) (P060040/S087)ABBOTT MEDICAL2022-10-14
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S049)ABBOTT MEDICAL2022-10-14
Aveir (P150035/S002)ABBOTT MEDICAL2022-10-06
Microny family of Pacemakers (P970013/S091)ABBOTT MEDICAL2022-09-30
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S325)ABBOTT MEDICAL2022-09-30
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and (P910023/S447)ABBOTT MEDICAL2022-09-30
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S401)ABBOTT MEDICAL2022-09-30
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S191)ABBOTT MEDICAL2022-09-30
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S075)ABBOTT MEDICAL2022-09-30
CardioMEMS™ HF System (P100045/S063)ABBOTT MEDICAL2022-09-15
Spinal Cord Stimulation (SCS) (P010032/S190)ABBOTT MEDICAL2022-09-09
MitraClip™ Clip Delivery System (P100009/S047)ABBOTT MEDICAL2022-09-09
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S448)ABBOTT MEDICAL2022-09-09
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S402)ABBOTT MEDICAL2022-09-09
Proclaim DRG Systems (P150004/S057)ABBOTT MEDICAL2022-08-19
Proclaim SCS Systems (P010032/S187)ABBOTT MEDICAL2022-08-19
Infinity DBS Systems (P140009/S077)ABBOTT MEDICAL2022-08-19
MitraClip G4 Clip Delivery System (P100009/S046)ABBOTT MEDICAL2022-08-16
MitraClip™ G4 Clip Delivery System (P100009/S045)ABBOTT MEDICAL2022-08-08
OptiSense, Tendril STS, Tendril SDX, Tendril ST (P960013/S121)ABBOTT MEDICAL2022-08-01
Tendril MRI (P140033/S074)ABBOTT MEDICAL2022-08-01
Quickflex µ, Quartet (P030054/S400)ABBOTT MEDICAL2022-08-01
Portico™ Transcatheter Aortic Valve Implantation System (P190023/S009)ABBOTT MEDICAL2022-08-01
IsoFlex (P960030/S076)ABBOTT MEDICAL2022-08-01
Durata, Optisure (P950022/S143)ABBOTT MEDICAL2022-08-01
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S004)ABBOTT MEDICAL2022-07-28
Assurity MRI, Endurity MRI, and Zenus MRI (P140033/S073)ABBOTT MEDICAL2022-07-14
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR (P910023/S446)ABBOTT MEDICAL2022-07-14
Avant HF, Neutrino NxT HF, Gallant HF, and Entrant HF (P030054/S399)ABBOTT MEDICAL2022-07-14
Allure Quadra (P030035/S190)ABBOTT MEDICAL2022-07-14
Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus (P880086/S324)ABBOTT MEDICAL2022-07-14
Portico Transcatheter Aortic Heart Valve (P190023/S008)ABBOTT MEDICAL2022-07-07
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S078)ABBOTT MEDICAL2022-06-30
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S188)ABBOTT MEDICAL2022-06-28
HeartMate II® Left Ventricular Assist System (P060040/S086)ABBOTT MEDICAL2022-06-23
Implantable Cardioverter Defibrillators (P910023/S445)ABBOTT MEDICAL2022-06-22
Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avant VR, Avant DR (P910023/S444)ABBOTT MEDICAL2022-05-18
Microny family of Pacemakers (P970013/S090)ABBOTT MEDICAL2022-05-17
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S443)ABBOTT MEDICAL2022-05-17
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S323)ABBOTT MEDICAL2022-05-17
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S072)ABBOTT MEDICAL2022-05-17
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S189)ABBOTT MEDICAL2022-05-17
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S398)ABBOTT MEDICAL2022-05-17
Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M (P150035/S001)ABBOTT MEDICAL2022-05-04
Epic Plus Tissue Heart Valves (P040021/S050)ABBOTT MEDICAL2022-04-26
Portico™ Transcatheter Aortic Heart Valve (P190023/S007)ABBOTT MEDICAL2022-04-20
Trifecta™ and Trifecta™ Valve with Glide Technology (Trifecta™ GT) valves (P100029/S046)ABBOTT MEDICAL2022-04-14
Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves (P040021/S049)ABBOTT MEDICAL2022-04-14
CardioMEMS™ HF System (P100045/S059)ABBOTT MEDICAL2022-04-12
CardioMEMS PA Sensor and Delivery System (P100045/S062)ABBOTT MEDICAL2022-04-11
HeartMate 3™ Left Ventricular Assist System (P160054/S047)ABBOTT MEDICAL2022-04-11
HeartMate II Left Ventricular Assist System (P060040/S085)ABBOTT MEDICAL2022-04-11
CardioMEMS HF System (P100045/S061)ABBOTT MEDICAL2022-03-31
Aveir VR Leadless System (P150035)ABBOTT MEDICAL2022-03-31
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S185)ABBOTT MEDICAL2022-03-24
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S056)ABBOTT MEDICAL2022-03-24
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S076)ABBOTT MEDICAL2022-03-24
HeartMate 3™ Left Ventricular Assist System (P160054/S039)ABBOTT MEDICAL2022-03-24
Portico™ (P190023/S005)ABBOTT MEDICAL2022-03-07
Portico Transcatheter Aortic Heart Valve (P190023/S006)ABBOTT MEDICAL2022-03-04
CardioMEMS HF System (P100045/S060)ABBOTT MEDICAL2022-03-04
CardioMEMs HF System (P100045/S056)ABBOTT MEDICAL2022-02-18
Dorsal Root Ganglion (DRG) System (P150004/S055)ABBOTT MEDICAL2022-02-17
Spinal Cord Stimulation (SCS) System (P010032/S184)ABBOTT MEDICAL2022-02-17
Infinity Deep Brain Stimulation (DBS) System (P140009/S075)ABBOTT MEDICAL2022-02-17
HeartMate 3™ Left Ventricular Assist System (P160054/S042)ABBOTT MEDICAL2022-02-16
HeartMate II Left Ventricular Assist System (P060040/S083)ABBOTT MEDICAL2022-01-28
HeartMate 3™ Left Ventricular Assist System (P160054/S045)ABBOTT MEDICAL2022-01-28
Amplatzer Duct Occluder, Amplatzer Duct Occluder II (P020024/S066)ABBOTT MEDICAL2022-01-13
Avant VR; Neutrino NxT VR; Gallant VR; Neutrino NxT VR; Entrant VR; Avant DR; Neutrino NxT DR; Gallant DR; Neutrino NxT (P910023/S442)ABBOTT MEDICAL2022-01-13
Amplatzer Septal Occluder and Amplatzer Cribriform Occluder (P000039/S076)ABBOTT MEDICAL2022-01-13
Avant HF; Neutrino NxT HF; Gallant HF; Neutrino NxT HF; Entrant HF; (P030054/S397)ABBOTT MEDICAL2022-01-13
Amplatzer Muscular VSD Occluder (P040040/S045)ABBOTT MEDICAL2022-01-13
Amplatzer PFO Occluder (P120021/S022)ABBOTT MEDICAL2022-01-13
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Every clearance here is in the API, with alerts when new ones post.