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ABBOTT MEDICAL

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

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RecordFirmDate
Navitor Transcatheter Aortic Heart Valves (P190023/S022)ABBOTT MEDICAL2024-09-30
HeartMate 3™ Left Ventricular Assist System (P160054/S083)ABBOTT MEDICAL2024-09-27
IsoFlex™ (P960030/S078)ABBOTT MEDICAL2024-09-26
Quartet™ (P030054/S424)ABBOTT MEDICAL2024-09-26
Aveir VR Leadless Pacemaker: Aveir™Leadless Pacemaker (Right Ventricular), Aveir™ DR Leadless Pacemaker: Aveir™ Leadless (P150035/S014)ABBOTT MEDICAL2024-09-26
Quadra Allure™, Quadra Allure MP™ (P030035/S203)ABBOTT MEDICAL2024-09-26
Tendril™ STS, UltiPace™ (P960013/S126)ABBOTT MEDICAL2024-09-26
Aveir™ Leadless System (Dual-Chamber) (P880086/S337)ABBOTT MEDICAL2024-09-25
Aveir™ Leadless System (Dual-Chamber) (P030054/S423)ABBOTT MEDICAL2024-09-25
Aveir™ Leadless System (Dual-Chamber) (P140033/S091)ABBOTT MEDICAL2024-09-25
Aveir™ Leadless System (Dual-Chamber) (P910023/S468)ABBOTT MEDICAL2024-09-25
Aveir™ Leadless System (Dual-Chamber) (P030035/S202)ABBOTT MEDICAL2024-09-25
Aveir™ Leadless System (Dual-Chamber) (P150035/S013)ABBOTT MEDICAL2024-09-25
HeartMate 3 Left Ventricular Assist System (P160054/S082)ABBOTT MEDICAL2024-09-23
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S105)ABBOTT MEDICAL2024-09-18
HeartMate 3™ Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P160054/S086)ABBOTT MEDICAL2024-09-18
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S224)ABBOTT MEDICAL2024-09-18
HeartMate II™ Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit (P060040/S108)ABBOTT MEDICAL2024-09-18
HeartMate 3™ Left Ventricular Assist System (P160054/S085)ABBOTT MEDICAL2024-09-11
HeartMate II™ Left Ventricular Assist System (P060040/S107)ABBOTT MEDICAL2024-09-11
Aveir™ VR Delivery Catheter, Aveir™ DR Delivery Catheter (P150035/S015)ABBOTT MEDICAL2024-08-29
CardioMEMS HF System (P100045/S076)ABBOTT MEDICAL2024-08-29
HeartMate 3™ Left Ventricular Assist System (P160054/S084)ABBOTT MEDICAL2024-08-28
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S006)ABBOTT MEDICAL2024-08-28
HeartMate II™ Left Ventricular Assist System (P060040/S106)ABBOTT MEDICAL2024-08-28
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S223)ABBOTT MEDICAL2024-08-23
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S104)ABBOTT MEDICAL2024-08-23
ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System (P230036/S004)ABBOTT MEDICAL2024-08-23
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) (P150004/S076)ABBOTT MEDICAL2024-08-23
Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) (P810002/S122)ABBOTT MEDICAL2024-08-15
Deep Brain Stimulation (DBS) (P140009/S102)ABBOTT MEDICAL2024-08-08
Spinal Cord Stimulation (SCS) (P010032/S221)ABBOTT MEDICAL2024-08-08
Avant, Entrant, Gallant, Neutrino NxT (P030054/S422)ABBOTT MEDICAL2024-08-02
Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1 (P140009/S099)ABBOTT MEDICAL2024-08-02
Patient Controller Application Version 2.0.2 (P010032/S218)ABBOTT MEDICAL2024-08-02
Avant, Entrant, Gallant, Neutrino NxT (P910023/S467)ABBOTT MEDICAL2024-08-02
Eterna™ SCS IPG (P010032/S219)ABBOTT MEDICAL2024-07-31
Liberta RC™ DBS IPG (P140009/S100)ABBOTT MEDICAL2024-07-31
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S005)ABBOTT MEDICAL2024-07-26
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S101)ABBOTT MEDICAL2024-07-26
HeartMate 3™ Left Ventricular Assist System (P160054/S074)ABBOTT MEDICAL2024-07-26
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S220)ABBOTT MEDICAL2024-07-26
Epic™ Plus Tissue Heart Valves, Epic™ Max Tissue Heart Valves, Epic™ Tissue Heart Valves (P040021/S058)ABBOTT MEDICAL2024-07-25
Genesis and EON Family Neurostimulation (IPG) System (P010032/S216)ABBOTT MEDICAL2024-07-24
Brio Neurostimulation System (P140009/S098)ABBOTT MEDICAL2024-07-24
Axium Neurostimulator System (P150004/S073)ABBOTT MEDICAL2024-07-24
TactiFlex Ablation Catheter, Sensor Enabled (P220013/S012)ABBOTT MEDICAL2024-07-21
DRG Delivery Sheath (P150004/S075)ABBOTT MEDICAL2024-07-17
HeartMate 3™ Left Ventricular Assist System (P160054/S081)ABBOTT MEDICAL2024-07-16
HeartMate II™ Left Ventricular Assist System (P060040/S105)ABBOTT MEDICAL2024-07-16
MitraClip™ G4 Clip Delivery System (P100009/S066)ABBOTT MEDICAL2024-07-16
Aveir™ VR Leadless Pacemaker (Right Ventricular), Aveir™ DR Leadless Pacemaker (Right Ventricular) (P150035/S012)ABBOTT MEDICAL2024-07-12
Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) (P810002/S123)ABBOTT MEDICAL2024-07-02
The Tendril MRI lead (P140033/S089)ABBOTT MEDICAL2024-07-02
Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder (P120021/S024)ABBOTT MEDICAL2024-06-26
Amplatzer Muscular VSD Occluder (P040040/S046)ABBOTT MEDICAL2024-06-26
Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S006)ABBOTT MEDICAL2024-06-26
Family of DBS IPGs (P140009/S095)ABBOTT MEDICAL2024-06-26
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S068)ABBOTT MEDICAL2024-06-26
Family of SCS IPGs (P010032/S213)ABBOTT MEDICAL2024-06-26
Family of DRG IPGs (P150004/S071)ABBOTT MEDICAL2024-06-26
Amplatzer Multifenestrated Septal Occluder – “Cribriform” (P000039/S078)ABBOTT MEDICAL2024-06-26
TactiFlex™ Ablation Catheter, Sensor Enabled™ (P220013/S002)ABBOTT MEDICAL2024-06-25
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S003)ABBOTT MEDICAL2024-06-21
TriClip G4 Delivery System (P230007/S002)ABBOTT MEDICAL2024-06-20
MitraClip G4 Clip Delivery System (P100009/S065)ABBOTT MEDICAL2024-06-20
Tendril MRI Pacing Lead (P140033/S090)ABBOTT MEDICAL2024-06-12
UltiPace Pacing Lead, Tendril STS Pacing Lead (P960013/S125)ABBOTT MEDICAL2024-06-12
Aveir™ Delivery Catheter (P150035/S011)ABBOTT MEDICAL2024-06-06
TriClip G4 System (P230007/S004)ABBOTT MEDICAL2024-05-31
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S080)ABBOTT MEDICAL2024-05-31
HeartMate II™ Left Ventricular Assist System (LVAS) (P060040/S104)ABBOTT MEDICAL2024-05-31
TriClip™ G4 System (P230007/S003)ABBOTT MEDICAL2024-05-31
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S002)ABBOTT MEDICAL2024-05-30
Epic Plus, Epic Plus Supra and Epic Max Valves in the Epic Valve Sterilization Process (P040021/S057)ABBOTT MEDICAL2024-05-30
Navitor TAVI System (P190023/S019)ABBOTT MEDICAL2024-05-29
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036/S001)ABBOTT MEDICAL2024-05-29
Fortify, Fortify Assura, Ellipse (P910023/S466)ABBOTT MEDICAL2024-05-22
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S421)ABBOTT MEDICAL2024-05-22
Deep Brain Stimulation (DBS) External Pulse Generator (EPG), Infinity DBS EPG Base (P140009/S097)ABBOTT MEDICAL2024-05-16
Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Proclaim SCS EPG Base (P010032/S215)ABBOTT MEDICAL2024-05-16
Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base (P150004/S072)ABBOTT MEDICAL2024-05-16
Entrant VR ICD, Entrant DR ICD, Gallant VR ICD, Gallant DR ICD Neutrino NxT VR ICD, Neutrino NxT DR ICD (P910023/S465)ABBOTT MEDICAL2024-05-14
HeartMate 3™ Left Ventricular Assist System (LVAS) (P160054/S079)ABBOTT MEDICAL2024-05-14
Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-D (P030054/S420)ABBOTT MEDICAL2024-05-14
CardioMEMS™ HF System (P100045/S075)ABBOTT MEDICAL2024-05-13
CardioMEMS™ HF System (P100045/S073)ABBOTT MEDICAL2024-05-13
TriClip™ G4 Clip Delivery System (P230007/S001)ABBOTT MEDICAL2024-05-09
HeartMate 3 Left Ventricular Assist System (P160054/S078)ABBOTT MEDICAL2024-05-02
Liberta RC™ DBS IPG (P140009/S092)ABBOTT MEDICAL2024-05-02
Eterna™ SCS IPG (P010032/S210)ABBOTT MEDICAL2024-05-02
Avant, Gallant, Entrant, Neutrino NxT Family of ICDs (P910023/S464)ABBOTT MEDICAL2024-05-01
Avant, Gallant, Entrant, Neutrino NxT Family of CRT-Ds (P030054/S419)ABBOTT MEDICAL2024-05-01
Assurity MRI, Endurity MRI, Zenus MRI and Zenex MRI Family of Pacemakers (P140033/S088)ABBOTT MEDICAL2024-05-01
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP family of CRT-Ps (P030035/S201)ABBOTT MEDICAL2024-05-01
Aveir VR Delivery Catheter and Aveir DR Delivery Catheter (P150035/S010)ABBOTT MEDICAL2024-05-01
Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family of Pacemakers (P880086/S336)ABBOTT MEDICAL2024-05-01
Eterna SCS IPG (P010032/S214)ABBOTT MEDICAL2024-04-30
Liberta RC DBS IPG (P140009/S096)ABBOTT MEDICAL2024-04-30
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System (P230036)ABBOTT MEDICAL2024-04-26
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