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Neurology

3,013 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
Infinity DBS IPG (P140009/S120)ABBOTT MEDICAL2025-07-02
Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S061)Nevro Corporation2025-06-30
Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management (P210037/S011)Biotronik Nro, Inc.2025-06-25
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S086)Boston Scientific Corp2025-06-25
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S384)Boston Scientific Corp2025-06-25
Altius Direct Electrical Nerve Stimulation System (P230020/S003)Neuros Medical, Inc.2025-06-25
Neuroform Atlas® Stent System (P180031/S006)Stryker Neurovascular2025-06-24
Liberta RC™ Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S119)ABBOTT MEDICAL2025-06-24
Eterna™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S238)ABBOTT MEDICAL2025-06-24
ReActiv8 Implantable Neurostimulation System (P190021/S009)Mainstay Medical Limited2025-06-20
Restore, Itrel®, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vect (P840001/S595)Medtronic Neuromodulation2025-06-18
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S507)Medtronic, Inc.2025-06-18
Activa™ and Percept™ Deep Brain Stimulation Therapy System (P960009/S503)Medtronic, Inc.2025-06-10
Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int (P840001/S591)Medtronic Neuromodulation2025-06-09
Liberta RC Deep Brain Stimulation Implantable Pulse Generator (P140009/S116)ABBOTT MEDICAL2025-06-09
Eterna Spinal Cord Stimulation Implantable Pulse Generator (P010032/S234)ABBOTT MEDICAL2025-06-09
Optune® (P100034/S040)Novocure, GmbH2025-06-06
Altius® Direct Electrical Nerve Stimulation System (P230020/S004)Neuros Medical, Inc.2025-06-05
CraniSeal Dural Sealant (P220014/S007)Pramand, LLC2025-06-04
SpineSeal Spine Sealant (P240027/S002)Pramand, LLC2025-06-04
Pipeline™ Flex Embolization Device (Pipeline™ Flex); Pipeline™ Flex Embolization Device with Shield Technology™ (Pipelin (P100018/S051)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-06-04
Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”) (P150038/S039)Insightec2025-06-03
Surpass Streamline Flow Diverter (P170024/S023)Stryker Neurovascular2025-05-30
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S085)Boston Scientific Corp2025-05-29
CraniSeal Dural Sealant (P220014/S006)Pramand, LLC2025-05-29
TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set (P990040/S035)Cerenovus, Inc.2025-05-28
Senza Spinal Cord Stimulation (SCS) System (P130022/S066)Nevro Corporation2025-05-27
Saluda Medical Evoke SCS System (P190002/S037)Saluda Medical Pty, Ltd.2025-05-27
Master Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, (P840001/S593)Medtronic Neuromodulation2025-05-21
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense TM (P960009/S505)Medtronic, Inc.2025-05-21
Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems (P150031/S083)Boston Scientific Corp2025-05-20
SCS System (P010032/S235)ABBOTT MEDICAL2025-05-16
DBS System (P140009/S117)ABBOTT MEDICAL2025-05-16
NEUROPACE RNS SYSTEM (P100026/S098)NeuroPace, Inc.2025-05-12
Neuroform Atlas Stent System (P180031/S011)Stryker Neurovascular2025-05-09
Altius Direct Electrical Nerve Stimulation System (P230020/S002)Neuros Medical, Inc.2025-05-06
VNS THERAPY SYSTEM (P970003/S247)LivaNova USA, Inc.2025-05-02
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S504)Medtronic, Inc.2025-04-11
Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an (P840001/S592)Medtronic Neuromodulation2025-04-11
Exablate Model 4000 System (P150038/S038)Insightec2025-04-04
Exablate 4000; Exablate Transcarnial MRgFUS; Exablate Neuro; Exablate Prime; ExAblate Neuravive (P150038/S040)Insightec2025-04-04
Senza HFX iQ System (P130022/S068)Nevro Corporation2025-03-28
VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 (P970003/S246)LivaNova USA, Inc.2025-03-27
Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline™ Shield) (P100018/S050)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-03-27
Optune® (P100034/S039)Novocure, GmbH2025-03-25
Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) (P150038/S026)Insightec2025-03-25
Prospera SCS System, Resilience Surgical Lead, Embrace One (P210037/S006)Biotronik Nro, Inc.2025-03-24
WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System (P030017/S381)Boston Scientific Corp2025-03-17
Deep Brain Stimulation (DBS) (P150031/S082)Boston Scientific Corp2025-03-17
Spinal Cord Stimulation (SCS) (P030017/S382)Boston Scientific Corp2025-03-17
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S590)Medtronic Neuromodulation2025-03-14
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S502)Medtronic, Inc.2025-03-14
BRIO NEUROSTIMULATION SYSTEM (P140009/S115)ABBOTT MEDICAL2025-03-13
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S233)ABBOTT MEDICAL2025-03-13
Spinal Cord Stimulation (SCS) External Pulse Generator (EPG) (P010032/S231)ABBOTT MEDICAL2025-03-12
SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip™ Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim (P150004/S074)ABBOTT MEDICAL2025-03-12
Dorsal Root Ganglion (DRG) External Pulse Generator (EPG) (P150004/S082)ABBOTT MEDICAL2025-03-12
Deep Brain Stimulation (DBS) External Pulse Generator (EPG) (P140009/S113)ABBOTT MEDICAL2025-03-12
Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage) (P100018/S049)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-03-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S501)Medtronic, Inc.2025-02-28
Restore, Itrel®, Synergy®, IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, an (P840001/S589)Medtronic Neuromodulation2025-02-28
CraniSeal Dural Sealant (P220014/S003)Pramand, LLC2025-02-28
Infinity Deep Brain Stimulation (DBS) IPG; Liberta RC DBS IPG (P140009/S114)ABBOTT MEDICAL2025-02-21
Proclaim™ Dorsal Root Ganglion (DRG) IPG (P150004/S083)ABBOTT MEDICAL2025-02-21
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG (P010032/S232)ABBOTT MEDICAL2025-02-21
Activa®, Percept™ and SenSight™ Deep Brain Stimulation Therapy System (P960009/S478)Medtronic, Inc.2025-02-20
Activa, Percept and SenSight Deep Brain Stimulation Therapy System (P960009/S483)Medtronic, Inc.2025-02-20
SpineSeal Spine Sealant (P240027)Pramand, LLC2025-02-14
Senza Spinal Cord Stimulation (SCS) System (P130022/S065)Nevro Corporation2025-02-14
Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris S (P840001/S575)Medtronic Neuromodulation2025-02-12
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S489)Medtronic, Inc.2025-02-12
Surpass Elite Flow Diverter System (P170024/S022)Stryker Neurovascular2025-02-12
CraniSeal Dural Sealant (P220014/S004)Pramand, LLC2025-02-11
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S491)Medtronic, Inc.2025-02-07
Restore, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectris® Spinal Cord St (P840001/S579)Medtronic Neuromodulation2025-02-07
Vercise™ DBS Controller (P150031/S076)Boston Scientific Corp2025-02-05
Optune Gio (P100034/S036)Novocure, GmbH2025-02-04
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense (P960009/S500)Medtronic, Inc.2025-01-15
Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Intellis™ Spinal Cord Stimulation System, (P840001/S588)Medtronic Neuromodulation2025-01-15
Saluda Medical Evoke SCS System (P190002/S034)Saluda Medical Pty, Ltd.2025-01-14
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
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S380)Boston Scientific Corp2025-01-08
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S081)Boston Scientific Corp2025-01-08
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S490)Medtronic, Inc.2025-01-06
Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S577)Medtronic Neuromodulation2025-01-06
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S497)Medtronic, Inc.2024-12-31
Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Sp (P840001/S585)Medtronic Neuromodulation2024-12-31
Activa and Percept Deep Brain Stimulation Therapy System (P960009/S486)Medtronic, Inc.2024-12-23
Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S586)Medtronic Neuromodulation2024-12-23
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S498)Medtronic, Inc.2024-12-23
Vercise Genus Deep Brain Stimulation System (P150031/S080)Boston Scientific Corp2024-12-23
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
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
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
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Every clearance here is in the API, with alerts when new ones post.