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ABBOTT MEDICAL

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

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RecordFirmDate
Avant™ HF, Neutrino™ NxT HF, Gallant ™ HF, Entrant™ HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu (P030054/S426)ABBOTT MEDICAL2025-02-05
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S339)ABBOTT MEDICAL2025-02-05
Aveir™ VR Leadless Pacemaker, Aveir™ DR Leadless Pacemaker (P150035/S021)ABBOTT MEDICAL2025-01-16
Proclaim™ Dorsal Root Ganglion (DRG) IPG (P150004/S079)ABBOTT MEDICAL2025-01-13
Proclaim™ Spinal Cord Simulation Implantable Pulse Generator (IPG) (P010032/S227)ABBOTT MEDICAL2025-01-13
Infinity™ Deep Brain Stimulation (DBS) (P140009/S109)ABBOTT MEDICAL2025-01-13
Navitor Transcatheter Aortic Valve Implantation (TAVI) System (P190023/S024)ABBOTT MEDICAL2025-01-06
TriClip G5 Delivery System (P230007/S005)ABBOTT MEDICAL2024-12-31
MitraClip G5 System (P100009/S067)ABBOTT MEDICAL2024-12-31
Eterna™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S222)ABBOTT MEDICAL2024-12-20
Liberta RC Deep Brain Stimulation (DBS) and NeuroSphere Digital Health App (P140009/S110)ABBOTT MEDICAL2024-12-20
Avant™ HF, Neutrino™ NxT HF, Gallant ™ HF, Neutrino™ NxT HF, Entrant™ HF (P030054/S408)ABBOTT MEDICAL2024-12-20
NeuroSphere Digital Health Apps (P150004/S080)ABBOTT MEDICAL2024-12-20
Eterna™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S229)ABBOTT MEDICAL2024-12-20
Avant™ VR, Avant™ DR, Neutrino™ NxT VR, Neutrino™ NxT DR, Gallant™ VR, Gallant™ DR, Entrant™ VR, Entrant™ DR (P910023/S455)ABBOTT MEDICAL2024-12-20
Eterna Spinal Cord Simulation Implantable Pulse Generator (IPG) and NeuroSphere Digital Health App (P010032/S228)ABBOTT MEDICAL2024-12-20
Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S103)ABBOTT MEDICAL2024-12-20
Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S111)ABBOTT MEDICAL2024-12-20
Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex (P880086/S341)ABBOTT MEDICAL2024-12-19
Avant, Neutrino NxT, Gallant, Entrant (P030054/S430)ABBOTT MEDICAL2024-12-19
Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S095)ABBOTT MEDICAL2024-12-19
Avant, Neutrino NxT, Gallant, Entrant (P910023/S474)ABBOTT MEDICAL2024-12-19
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP (P030035/S207)ABBOTT MEDICAL2024-12-19
Microny family of Pacemakers (P970013/S095)ABBOTT MEDICAL2024-12-18
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S204)ABBOTT MEDICAL2024-12-18
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S425)ABBOTT MEDICAL2024-12-18
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S111)ABBOTT MEDICAL2024-12-18
ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System (P230036/S008)ABBOTT MEDICAL2024-12-18
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S469)ABBOTT MEDICAL2024-12-18
Aveir Leadless System (P150035/S016)ABBOTT MEDICAL2024-12-18
HeartMate 3™ Left Ventricular Assist System (P160054/S093)ABBOTT MEDICAL2024-12-18
Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S338)ABBOTT MEDICAL2024-12-18
Assurity MRI, Endurity MRI family of Pacemakers (P140033/S092)ABBOTT MEDICAL2024-12-18
HeartMate 3™ Left Ventricular Assist System (P160054/S092)ABBOTT MEDICAL2024-12-17
HeartMate II Left Ventricular Assist System (P060040/S110)ABBOTT MEDICAL2024-12-17
Aveir VR Leadless System (P150035/S019)ABBOTT MEDICAL2024-12-17
Avant HF, Entrant HF, Gallant HF, Neutrino NxT HF (P030054/S429)ABBOTT MEDICAL2024-12-13
Amplatzer™ Muscular VSD Occluder (P040040/S049)ABBOTT MEDICAL2024-12-13
Spinal Cord Stimulation (SCS) Leads, Extensions, & Adapters (P010032/S230)ABBOTT MEDICAL2024-12-13
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S008)ABBOTT MEDICAL2024-12-13
Deep Brain Stimulation (DBS) Extensions & Adapters (P140009/S112)ABBOTT MEDICAL2024-12-13
FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) (P110016/S087)ABBOTT MEDICAL2024-12-13
Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder (P020024/S070)ABBOTT MEDICAL2024-12-13
Axium Neurostimulator System (P150004/S081)ABBOTT MEDICAL2024-12-13
Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder (P120021/S026)ABBOTT MEDICAL2024-12-13
Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform” (P000039/S080)ABBOTT MEDICAL2024-12-13
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S007)ABBOTT MEDICAL2024-12-11
Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S009)ABBOTT MEDICAL2024-12-10
CardioMEMS HF System (P100045/S080)ABBOTT MEDICAL2024-12-06
Infinity™ Deep Brain Stimulation (DBS) IPG (P140009/S107)ABBOTT MEDICAL2024-12-03
HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P060040/S109)ABBOTT MEDICAL2024-12-03
Proclaim™ Doral Root Ganglion (DRG) IPG (P150004/S077)ABBOTT MEDICAL2024-12-03
HeartMate 3™ Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P160054/S087)ABBOTT MEDICAL2024-12-03
Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S226)ABBOTT MEDICAL2024-12-03
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S015)ABBOTT MEDICAL2024-11-27
TriClip™ G4 Clip Delivery System (P230007/S008)ABBOTT MEDICAL2024-11-25
MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System (P100009/S069)ABBOTT MEDICAL2024-11-25
Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular, (P150035/S020)ABBOTT MEDICAL2024-11-22
SCS EPG 2-Port Header (Model 3042) (P010032/S217)ABBOTT MEDICAL2024-11-22
Avant, Entrant, Fortify, Fortify Assura, Gallant, Neutrino NxT (P910023/S473)ABBOTT MEDICAL2024-11-22
TactiFlex Ablation Catheter, Sensor Enabled (P220013/S014)ABBOTT MEDICAL2024-11-22
Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra (P030054/S428)ABBOTT MEDICAL2024-11-22
HeartMate 3 Left Ventricular Assist System (P160054/S091)ABBOTT MEDICAL2024-11-19
HeartMate 3™ Left Ventricular Assist System (P160054/S089)ABBOTT MEDICAL2024-11-19
HeartMate 3™ Left Ventricular Assist System (P160054/S090)ABBOTT MEDICAL2024-11-18
CardioMEMS HF System (P100045/S078)ABBOTT MEDICAL2024-11-15
HeartMate 3™ Left Ventricular Assist System (P160054/S088)ABBOTT MEDICAL2024-11-14
Eterna™ SCS Charging System (P010032/S225)ABBOTT MEDICAL2024-11-13
Liberta RC™ DBS Charging System (P140009/S106)ABBOTT MEDICAL2024-11-13
TriClip G4 System (P230007/S007)ABBOTT MEDICAL2024-11-13
Amplatzer™ Muscular VSD Occluder (P040040/S048)ABBOTT MEDICAL2024-11-01
Assurity, Assurity +, Endurity, Endurity Core, Zenus, Zenex, Accent (P880086/S340)ABBOTT MEDICAL2024-10-28
Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S094)ABBOTT MEDICAL2024-10-28
Unify™, Unify Quadra™, Unify Assura™, Quadra Assura™, Quadra Assura MP™, Avant, Neutrino NxT, Gallant, Entrant (P030054/S427)ABBOTT MEDICAL2024-10-28
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP, Anthem (P030035/S206)ABBOTT MEDICAL2024-10-28
Avant, Neutrino NxT, Gallant, Entrant, Fortify™ VR, Fortify™ DR, Ellipse™ VR, Ellipse™ DR, Fortify Assura™ VR, Fortify A (P910023/S472)ABBOTT MEDICAL2024-10-28
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S108)ABBOTT MEDICAL2024-10-24
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S078)ABBOTT MEDICAL2024-10-24
MitraClip™ G4 Clip Delivery System (P100009/S068)ABBOTT MEDICAL2024-10-22
Navitor™ Titan Valve (P190023/S023)ABBOTT MEDICAL2024-10-22
TriClip™ G4 Clip Delivery System (P230007/S006)ABBOTT MEDICAL2024-10-22
Aveir™ VR Delivery Catheter (P150035/S018)ABBOTT MEDICAL2024-10-17
Epic Plus, Epic Max Tissue Heart Valves (P040021/S054)ABBOTT MEDICAL2024-10-17
Merlin.net™ MN5000 (P880086/S334)ABBOTT MEDICAL2024-10-11
Merlin.net™ MN5000 (P140033/S086)ABBOTT MEDICAL2024-10-11
Merlin.net™ MN5000 (P030054/S418)ABBOTT MEDICAL2024-10-11
AVEIR™ Patient Transmitter, AVEIR™ Patient Transmitter Software, AVEIR™ Patient Trasmitter Wired Electrodes, Merlin.net™ (P150035/S007)ABBOTT MEDICAL2024-10-11
Merlin.net™ MN5000 (P910023/S463)ABBOTT MEDICAL2024-10-11
Merlin.net™ MN5000 (P030035/S199)ABBOTT MEDICAL2024-10-11
TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (P220013/S013)ABBOTT MEDICAL2024-10-09
Genesis Neurostimulation System (P010032/S211)ABBOTT MEDICAL2024-10-08
Axium Neurostimulator System (P150004/S069)ABBOTT MEDICAL2024-10-08
Brio Neurostimulation System (P140009/S093)ABBOTT MEDICAL2024-10-08
Ellipse DR, Ellipse VR (P910023/S471)ABBOTT MEDICAL2024-10-03
Amplatzer™ PFO Occluder, Amplatzer™ Talisman™ PFO Occluder (P120021/S025)ABBOTT MEDICAL2024-10-01
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S007)ABBOTT MEDICAL2024-10-01
Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform” (P000039/S079)ABBOTT MEDICAL2024-10-01
Amplatzer™ Muscular VSD Occluder (P040040/S047)ABBOTT MEDICAL2024-10-01
FlexNav™ and Navitor Loading System, FlexNav™ Delivery System (P190023/S020)ABBOTT MEDICAL2024-10-01
Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder (P020024/S069)ABBOTT MEDICAL2024-10-01
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Every clearance here is in the API, with alerts when new ones post.