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Neurology

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

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RecordFirmDate
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P150004/S062)ABBOTT MEDICAL2023-07-21
Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P010032/S199)ABBOTT MEDICAL2023-07-21
Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P140009/S085)ABBOTT MEDICAL2023-07-21
Exablate 4000 (Exablate Neuro) (P150038/S029)Insightec2023-07-21
Exablate Model 4000 System (P150038/S030)Insightec2023-07-21
Prospera SCS System (P210037/S001)Biotronik Nro, Inc.2023-07-20
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S454)Medtronic, Inc.2023-07-20
Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) (P150038/S015)Insightec2023-07-18
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S056)Boston Scientific Corp2023-07-10
CraniSeal Dural Sealant (P220014)Pramand, LLC2023-07-06
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S059)Boston Scientific Corp2023-06-30
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S364)Boston Scientific Corp2023-06-30
Reactiv8 Implantable Neurostimulation System (P190021/S003)Mainstay Medical Limited2023-06-23
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S (P840001/S543)Medtronic Neuromodulation2023-06-21
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S453)Medtronic, Inc.2023-06-21
Precision Passing Elevator (P030017/S351)Boston Scientific Corp2023-06-06
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) (P150004/S061)ABBOTT MEDICAL2023-06-02
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S452)Medtronic, Inc.2023-06-02
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® Spinal C (P840001/S542)Medtronic Neuromodulation2023-06-02
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S083)ABBOTT MEDICAL2023-06-02
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S198)ABBOTT MEDICAL2023-06-02
DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL) (P080013/S026)Integra LifeSciences Corporation2023-05-24
DuraSeal Dural Sealant System (P040034/S037)Integra LifeSciences Corporation2023-05-24
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S013)MicroVention, Inc.2023-05-22
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S360)Boston Scientific Corp2023-05-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S362)Boston Scientific Corp2023-05-15
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S058)Boston Scientific Corp2023-05-15
Senza HFX iQ System (model IPG3000) (P130022/S048)Nevro Corporation2023-05-12
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S057)Boston Scientific Corp2023-05-12
Precision Spinal Cord Stimulator (SCS Systems) (P030017/S361)Boston Scientific Corp2023-05-12
Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems (P010032/S191)ABBOTT MEDICAL2023-05-10
Saluda Medical Evoke SCS System (P190002/S012)Saluda Medical Pty, Ltd.2023-05-05
Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt (P010032/S193)ABBOTT MEDICAL2023-05-05
- Master Restore, Itrel®, Synergy®, Intellis TM and VantaTM Spinal Cord Stimulation Systems and Pisces TM, Specify®, and (P840001/S541)Medtronic Neuromodulation2023-05-04
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S197)ABBOTT MEDICAL2023-05-04
Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S060)ABBOTT MEDICAL2023-05-04
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S451)Medtronic, Inc.2023-05-04
Spinal Cord Stimulation (SCS) System (P010032/S192)ABBOTT MEDICAL2023-04-28
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S450)Medtronic, Inc.2023-04-20
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S (P840001/S539)Medtronic Neuromodulation2023-04-20
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S (P840001/S540)Medtronic Neuromodulation2023-04-20
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S082)ABBOTT MEDICAL2023-04-07
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S059)ABBOTT MEDICAL2023-04-07
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S196)ABBOTT MEDICAL2023-04-07
Adherus AutoSpray Dural Sealant, Adherus ET AutoSpray Dural Sealant (P130014/S017)Stryker Leibinger GmbH & Co KG2023-04-05
Saluda Medical Evoke® SCS System (P190002/S016)Saluda Medical Pty, Ltd.2023-04-04
Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management (P210037)Biotronik Nro, Inc.2023-03-31
Spinal Cord Stimulator (SCS) Accessories (P840001/S537)Medtronic Neuromodulation2023-03-17
Deep Brain Stimulation (DBS) Accessories (P960009/S447)Medtronic, Inc.2023-03-17
Pipeline™ Flex with Shield Technology™ (P100018/S039)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2023-03-16
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S538)Medtronic Neuromodulation2023-03-16
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S448)Medtronic, Inc.2023-03-16
Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S418)Medtronic, Inc.2023-03-14
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems (P840001/S509)Medtronic Neuromodulation2023-03-14
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S449)Medtronic, Inc.2023-03-10
VNS Therapy System (P970003/S239)LivaNova USA, Inc.2023-03-02
VNS Therapy System (P970003/S240)LivaNova USA, Inc.2023-03-02
Pipeline Flex Embolization Device, Pipeline Flex Embolization Device with Shield Technology (P100018/S038)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2023-02-28
TRUFILL n-BCA Liquid Embolic System (P990040/S030)Cerenovus, Inc.2023-02-28
Vercise Genus DBS System (P150031/S052)Boston Scientific Corp2023-02-23
NeuroPace® RNS® System (P100026/S093)NeuroPace, Inc.2023-02-17
Reactiv8 Implantable Neurostimulation System (P190021/S004)Mainstay Medical Limited2023-02-16
DuraSeal Exact Spinal Sealant (P080013/S025)Integra LifeSciences Corporation2023-02-16
DuraSeal Dural Sealant System (P040034/S036)Integra LifeSciences Corporation2023-02-16
NeuroPace® RNS® System (P100026/S092)NeuroPace, Inc.2023-02-10
Demipulse™ Generator; Demipulse Duo™ Generator, AspireSR™ Generator, SenTiva™ Generator; SenTiva Duo™ Generator, Symmetr (P970003/S238)LivaNova USA, Inc.2023-02-07
Activa® Deep Brain Stimulation Therapy System (P960009/S446)Medtronic, Inc.2023-02-02
Restore and Itrel® Spinal Cord Stimulation Systems (P840001/S536)Medtronic Neuromodulation2023-02-02
Nevro Corp Senza™ Spinal Cord Stimulation (SCS) System (P130022/S045)Nevro Corporation2023-01-27
DuraSeal Dural Sealant System (P040034/S033)Integra LifeSciences Corporation2023-01-25
DuraSeal Exact Spine Sealant System (P080013/S022)Integra LifeSciences Corporation2023-01-25
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems (P010032/S189)ABBOTT MEDICAL2023-01-24
VNS Therapy System (P970003/S237)LivaNova USA, Inc.2023-01-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S054)Boston Scientific Corp2023-01-06
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S356)Boston Scientific Corp2023-01-06
Adherus AutoSpray Dural Sealant, Adherus ET Autospray Dural Sealant (P130014/S016)Stryker Leibinger GmbH & Co KG2023-01-05
Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp (P030017/S359)Boston Scientific Corp2023-01-04
NeuroPace® RNS® System (P100026/S091)NeuroPace, Inc.2022-12-29
Saluda Medical Evoke® SCS System (P190002/S015)Saluda Medical Pty, Ltd.2022-12-29
Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System (P130022/S047)Nevro Corporation2022-12-23
Wave Writer Alpha™ Spinal Cord Stimulator (SCS) System, Spectra Wave Writer™ Spinal Cord Stimulator (SCS) System, Precis (P030017/S353)Boston Scientific Corp2022-12-19
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S355)Boston Scientific Corp2022-12-17
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S053)Boston Scientific Corp2022-12-17
Eterna SCS IPG, Charger, Patient Controller Application, Clinician Programmer Application (P010032/S186)ABBOTT MEDICAL2022-12-16
Saluda Medical Evoke® SCS System (P190002/S013)Saluda Medical Pty, Ltd.2022-12-15
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S010)MicroVention, Inc.2022-12-09
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S444)Medtronic, Inc.2022-12-08
Exablate 4000 System Type-1 (i.e. Type 1.0/1.1) (P150038/S022)Insightec2022-12-08
Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal Cord Stim (P840001/S534)Medtronic Neuromodulation2022-12-08
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S532)Medtronic Neuromodulation2022-11-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S442)Medtronic, Inc.2022-11-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S443)Medtronic, Inc.2022-11-22
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S533)Medtronic Neuromodulation2022-11-22
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S352)Boston Scientific Corp2022-11-22
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S051)Boston Scientific Corp2022-11-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S441)Medtronic, Inc.2022-11-16
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S531)Medtronic Neuromodulation2022-11-16
Neuroform Atlas® Stent System (P180031/S005)Stryker Neurovascular2022-11-15
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S024)Insightec2022-11-11
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S023)Insightec2022-11-02
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Every clearance here is in the API, with alerts when new ones post.