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ABBOTT MEDICAL

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

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RecordFirmDate
HeartMate 3 Left Ventricular Assist System (P160054/S077)ABBOTT MEDICAL2024-04-16
HeartMate II Left Ventricular Assist System (P060040/S103)ABBOTT MEDICAL2024-04-16
MitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System (P100009/S064)ABBOTT MEDICAL2024-04-09
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S212)ABBOTT MEDICAL2024-04-05
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S070)ABBOTT MEDICAL2024-04-05
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S094)ABBOTT MEDICAL2024-04-05
Aveir™ VR Delivery Catheter, Aveir™ DR Delivery Catheter (P150035/S009)ABBOTT MEDICAL2024-04-04
Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology (P810002/S121)ABBOTT MEDICAL2024-04-03
CardioMEMS Hospital System, model CM3100 (P100045/S074)ABBOTT MEDICAL2024-04-02
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S076)ABBOTT MEDICAL2024-04-01
HeartMate II™ Left Ventricular Assist System (LVAS) (P060040/S102)ABBOTT MEDICAL2024-04-01
TriClip G4 System (P230007)ABBOTT MEDICAL2024-04-01
Aveir™ VR Leadless Pacemaker: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ DR Leadless Pacemaker: Aveir™ Leadle (P150035/S008)ABBOTT MEDICAL2024-03-29
Accent, Assurity, Assurity+, Endurity, Endurity Core, Zenex, Zenus (P880086/S335)ABBOTT MEDICAL2024-03-27
Anthem,Allure, Allure Quadra, Quadra Allure (MRI Conditional),Quadra Allure MP (P030035/S200)ABBOTT MEDICAL2024-03-27
Assurity MRI, Endurity MRI,Zenex MRI (P140033/S087)ABBOTT MEDICAL2024-03-27
Tendril STS, UltiPace (P960013/S124)ABBOTT MEDICAL2024-03-26
Assurity MRI, Endurity MRI (P140033/S085)ABBOTT MEDICAL2024-03-26
Navitor™ Transcatheter Aortic Valve, Navitor™ Loading System , FlexNav™ Delivery System, Navitor™ Titan™ Transcatheter A (P190023/S018)ABBOTT MEDICAL2024-03-21
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S101)ABBOTT MEDICAL2024-03-21
TVL(TM) Lead System (P950022/S145)ABBOTT MEDICAL2024-03-18
Aveir™ Delivery Catheter (P150035/S006)ABBOTT MEDICAL2024-03-06
HeartMate 3™ Left Ventricular Assist System (P160054/S069)ABBOTT MEDICAL2024-02-29
HeartMate 3 Left Ventricular Assist System (P160054/S075)ABBOTT MEDICAL2024-02-29
HeartMate II Left Ventricular Assist System (P060040/S100)ABBOTT MEDICAL2024-02-29
Endurity, Assurity, Endurity Core, Zenus, Zenex (P880086/S332)ABBOTT MEDICAL2024-02-28
Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S083)ABBOTT MEDICAL2024-02-28
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S073)ABBOTT MEDICAL2024-02-22
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S072)ABBOTT MEDICAL2024-02-21
DBS System - Lead and Extension (P140009/S084)ABBOTT MEDICAL2024-02-21
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S417)ABBOTT MEDICAL2024-02-21
Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify (P910023/S462)ABBOTT MEDICAL2024-02-21
MitraClip G4 System (P100009/S063)ABBOTT MEDICAL2024-02-14
HeartMate 3™ Left Ventricular Assist System (P160054/S064)ABBOTT MEDICAL2024-02-02
Spinal Cord Stimulation (SCS) Leads (P010032/S209)ABBOTT MEDICAL2024-02-02
Infinity Deep Brain Stimulation (DBS) Leads (P140009/S091)ABBOTT MEDICAL2024-02-02
HeartMate 3™ Left Ventricular Assist System (P160054/S070)ABBOTT MEDICAL2024-01-31
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S098)ABBOTT MEDICAL2024-01-31
CardioMEMS™ HF System (P100045/S072)ABBOTT MEDICAL2024-01-31
Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application (P140009/S087)ABBOTT MEDICAL2024-01-24
Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application (P010032/S202)ABBOTT MEDICAL2024-01-24
Epic Plus and Epic Plus Supra (P040021/S056)ABBOTT MEDICAL2024-01-23
DRG System - Leads and Extensions (P150004/S065)ABBOTT MEDICAL2024-01-22
MitraClip™ G4 Clip Delivery System (P100009/S061)ABBOTT MEDICAL2024-01-22
CardioMEMS HF System (P100045/S071)ABBOTT MEDICAL2024-01-19
HeartMate 3™ Left Ventricular Assist System (P160054/S056)ABBOTT MEDICAL2024-01-11
Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit (P150004/S068)ABBOTT MEDICAL2024-01-10
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S071)ABBOTT MEDICAL2023-12-28
HeartMate II™ Left Ventricular Assist System (LVAS) (P060040/S099)ABBOTT MEDICAL2023-12-28
Accent, Accent MRI, Assurity, Assurity+, Endurity, Endurity Core (P880086/S331)ABBOTT MEDICAL2023-12-27
Microny (P970013/S093)ABBOTT MEDICAL2023-12-27
Endurity MRI, Assurity MRI (P140033/S082)ABBOTT MEDICAL2023-12-27
Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT (P030054/S415)ABBOTT MEDICAL2023-12-27
Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT (P910023/S460)ABBOTT MEDICAL2023-12-27
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S197)ABBOTT MEDICAL2023-12-27
HeartMate II Left Ventricular Assist System (LVAS) (P060040/S096)ABBOTT MEDICAL2023-12-23
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S066)ABBOTT MEDICAL2023-12-23
Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor (P150004/S063)ABBOTT MEDICAL2023-12-19
Charger, Model 16000 (P010032/S206)ABBOTT MEDICAL2023-12-19
Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves (P040021/S055)ABBOTT MEDICAL2023-12-18
Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves (P190023/S017)ABBOTT MEDICAL2023-12-18
HeartMate II™ Left Ventricular Assist System (P060040/S097)ABBOTT MEDICAL2023-12-14
HeartMate 3™ Left Ventricular Assist System (P160054/S068)ABBOTT MEDICAL2023-12-14
SJM Masters Series Mechanical Heart Valve, 15mm HP (P810002/S119)ABBOTT MEDICAL2023-12-04
Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR (P910023/S459)ABBOTT MEDICAL2023-12-01
Avant™ HF, Neutrino™ NxT HF, Gallant™ HF, Entrant™ HF (P030054/S414)ABBOTT MEDICAL2023-12-01
MitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System (P100009/S062)ABBOTT MEDICAL2023-12-01
Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit (P220013/S001)ABBOTT MEDICAL2023-11-29
Ampere™ Generator, Ampere™ Remote Control, Ampere™ Generator System Kit (P110016/S084)ABBOTT MEDICAL2023-11-29
Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P030054/S412)ABBOTT MEDICAL2023-11-29
Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P950022/S144)ABBOTT MEDICAL2023-11-29
Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P910023/S457)ABBOTT MEDICAL2023-11-29
Tendril STS, UltiPace (P960013/S123)ABBOTT MEDICAL2023-11-28
Proclaim DRG IPG (P150004/S052)ABBOTT MEDICAL2023-11-27
MitraClip™ G4 Clip Delivery System (P100009/S055)ABBOTT MEDICAL2023-11-20
HeartMate II™ Left Ventricular Assist System (P060040/S095)ABBOTT MEDICAL2023-11-16
HeartMate 3™ Left Ventricular Assist System (P160054/S065)ABBOTT MEDICAL2023-11-16
PorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves (P190023/S016)ABBOTT MEDICAL2023-11-07
Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura (P910023/S458)ABBOTT MEDICAL2023-10-31
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S413)ABBOTT MEDICAL2023-10-31
Spinal Cord Stimulation (SCS) Legacy Charger Systems and Accessories (P010032/S207)ABBOTT MEDICAL2023-10-27
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S061)ABBOTT MEDICAL2023-10-27
MitraClip™ G4 Clip Delivery System (P100009/S060)ABBOTT MEDICAL2023-10-27
CardioMEMSTM HF System (P100045/S070)ABBOTT MEDICAL2023-10-27
Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories (P140009/S090)ABBOTT MEDICAL2023-10-27
FlexAbility™ Ablation Catheter, FlexAbility™ Ablation Catheter, Sensor Enabled™ (P110016/S086)ABBOTT MEDICAL2023-10-26
Eterna SCS IPG (P010032/S205)ABBOTT MEDICAL2023-10-26
TactiFlex™ Ablation CatTactiFlex™ Ablation Catheter, Sensor Enabled™heter, Sensor Enabled™, TactiSys™ Quartz Equipment, (P220013/S008)ABBOTT MEDICAL2023-10-26
HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S063)ABBOTT MEDICAL2023-10-25
HeartMate II Left Ventricular Assist System (P060040/S094)ABBOTT MEDICAL2023-10-24
TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) (P220013/S010)ABBOTT MEDICAL2023-10-24
HeartMate 3 Left Ventricular Assist System (P160054/S062)ABBOTT MEDICAL2023-10-24
HeartMate II Left Ventricular Assist System (P060040/S093)ABBOTT MEDICAL2023-10-20
HeartMate 3™ Left Ventricular Assist System (P160054/S060)ABBOTT MEDICAL2023-10-20
SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft (P810002/S120)ABBOTT MEDICAL2023-10-18
Epic™ Supra Valve, Epic™ Valve, Epic™ Plus Stented Tissue Valve, Epic™ Plus Supra Valve, Epic™ Max Valve (P040021/S053)ABBOTT MEDICAL2023-10-18
MitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System (P100009/S059)ABBOTT MEDICAL2023-10-17
TactiFlex SE Ablation Catheter, Sensor Enabled (P220013/S009)ABBOTT MEDICAL2023-10-13
MitraClip G4 Delivery System (P100009/S058)ABBOTT MEDICAL2023-10-12
Eterna SCS System (P010032/S200)ABBOTT MEDICAL2023-10-05
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Every clearance here is in the API, with alerts when new ones post.