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Neurology

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

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RecordFirmDate
Infinity Deep Brain Stimulation (DBS) System (P140009/S075)ABBOTT MEDICAL2022-02-17
Flow Re-Direction Endoluminal Device (FRED) and FRED X System (P180027/S006)MicroVention, Inc.2022-02-15
Adherus AutoSpray Dural Sealant, NUS-106 (P130014/S014)Stryker Leibinger GmbH & Co KG2022-02-14
Pipeline™ Flex, Pipeline™ Flex with Shield Technology™ (P100018/S035)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2022-02-08
Neuroform Atlas® Stent System (P180031/S004)Stryker Neurovascular2022-02-07
Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spina Cord Stimulati (P840001/S508)Medtronic Neuromodulation2022-02-04
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S505)Medtronic Neuromodulation2022-02-01
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S415)Medtronic, Inc.2022-02-01
Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St (P840001/S469)Medtronic Neuromodulation2022-01-21
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S416)Medtronic, Inc.2022-01-19
Master Restore, ltrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spin (P840001/S507)Medtronic Neuromodulation2022-01-19
Senza Spinal Cord Stimulation (SCS) System (P130022/S042)Nevro Corporation2022-01-18
NeuroPace® RNS® System (P100026/S088)NeuroPace, Inc.2022-01-18
WEB Aneurysm Embolization System (P170032/S011)MicroVention, Inc.2022-01-14
Deep Brain Stimulation (DBS) System (P140009/S073)ABBOTT MEDICAL2021-12-30
Spinal Cord Stimulation (SCS) System (P010032/S180)ABBOTT MEDICAL2021-12-30
Dorsal Root Ganglion (DRG) System (P150004/S053)ABBOTT MEDICAL2021-12-30
Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™ (P100018/S036)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-12-27
(WEB) Aneurysm Embolization System (P170032/S010)MicroVention, Inc.2021-12-20
Adherus AutoSpray ET Dural Sealant, Adherus AutoSpray Dural Sealant (P130014/S013)Stryker Leibinger GmbH & Co KG2021-12-17
NeuroPace® RNS® System (P100026/S089)NeuroPace, Inc.2021-12-16
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ Implantable Neurostimulator (P960009/S414)Medtronic, Inc.2021-12-15
Master Restore, Itrel®, Synergy® and Intellis™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spina (P840001/S504)Medtronic Neuromodulation2021-12-15
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S047)Boston Scientific Corp2021-12-14
Precision Spinal Cord Stimulator {SCS) Systems (P030017/S349)Boston Scientific Corp2021-12-14
Master Restore, Itrel, Synergy, lntellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Yectris Spin (P840001/S503)Medtronic Neuromodulation2021-12-03
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S413)Medtronic, Inc.2021-12-03
Surpass Evolve Flow Diverter System (P170024/S011)Stryker Neurovascular2021-11-30
SenSight Burr Hole Device, SenSight Burr Hole Device Kit (P960009/S411)Medtronic, Inc.2021-11-19
DuraSeal Exact Spinal Sealant System. (P080013/S023)Integra LifeSciences Corporation2021-11-17
DuraSeal Dural Sealant System. (P040034/S034)Integra LifeSciences Corporation2021-11-17
Proclaim SCS Neurostimulation System (P010032/S176)ABBOTT MEDICAL2021-11-17
Proclaim DRG IPG (P150004/S054)ABBOTT MEDICAL2021-11-16
Infinity DBS IPG (P140009/S074)ABBOTT MEDICAL2021-11-16
Proclaim SCS IPG (P010032/S183)ABBOTT MEDICAL2021-11-16
Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems (P150031/S039)Boston Scientific Corp2021-11-15
Vercise Genus™ Deep Brain Stimulation (DBS) System (P150031/S046)Boston Scientific Corp2021-11-10
WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System (P030017/S348)Boston Scientific Corp2021-11-10
Activa® Deep Brain Stimulation Therapy System; Percept™ PC BrainSense™ (P960009/S412)Medtronic, Inc.2021-11-05
Eon Mini™ IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P (P010032/S182)ABBOTT MEDICAL2021-11-04
Genesis Neurostimulation System (P010032/S181)ABBOTT MEDICAL2021-11-03
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S014)Insightec2021-10-29
SenSight™ Extension Kit (P960009/S410)Medtronic, Inc.2021-10-27
Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti (P840001/S497)Medtronic Neuromodulation2021-10-26
Vercise PC, Vercise Gevia and Vercise Genus DBS Systems (P150031/S040)Boston Scientific Corp2021-10-20
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S009)MicroVention, Inc.2021-10-14
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S007)MicroVention, Inc.2021-10-08
Vercise Genus™ Deep Brain Stimulation (DBS) System (P150031/S044)Boston Scientific Corp2021-10-07
Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System (P030017/S347)Boston Scientific Corp2021-10-07
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S178)ABBOTT MEDICAL2021-09-27
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S071)ABBOTT MEDICAL2021-09-27
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S049)ABBOTT MEDICAL2021-09-27
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S005)MicroVention, Inc.2021-09-16
Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S002)MicroVention, Inc.2021-09-16
Onyx™ Liquid Embolic System (P030004/S027)Ev3 Neurovascular2021-09-16
Adherus AutoSpray ET Dural Sealant (P130014/S012)Stryker Leibinger GmbH & Co KG2021-09-15
Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm (P030004/S028)Ev3 Neurovascular2021-09-14
SenSight™ Directional Lead Kit (P960009/S407)Medtronic, Inc.2021-09-09
Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C (P840001/S498)Medtronic Neuromodulation2021-09-01
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S406)Medtronic, Inc.2021-09-01
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S484)Medtronic Neuromodulation2021-08-30
Activa Deep Brain Stimulation Therapy System (P960009/S396)Medtronic, Inc.2021-08-30
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S489)Medtronic Neuromodulation2021-08-25
SenSight™ Directional Lead Kit, SenSight™ Extension Kit (P960009/S405)Medtronic, Inc.2021-08-20
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S496)Medtronic Neuromodulation2021-08-13
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S404)Medtronic, Inc.2021-08-13
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S488)Medtronic Neuromodulation2021-08-12
Axium Neurostimulator System (P150004/S051)ABBOTT MEDICAL2021-08-05
SenSight Diectional Lead Kit (P960009/S403)Medtronic, Inc.2021-07-29
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S072)ABBOTT MEDICAL2021-07-28
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S179)ABBOTT MEDICAL2021-07-28
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S050)ABBOTT MEDICAL2021-07-28
Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology (P100018/S033)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-07-27
Deep Brain Stimulation (DBS) (P140009/S067)ABBOTT MEDICAL2021-07-26
Spinal Cord Stimulation (SCS) (P010032/S172)ABBOTT MEDICAL2021-07-26
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”) (P150038/S013)Insightec2021-07-22
Activa® Deep Brain Stimulation Therapy System (P960009/S402)Medtronic, Inc.2021-07-21
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (P840001/S492)Medtronic Neuromodulation2021-07-21
Pipeline Flex Embolization Device with Shield Technology (P100018/S032)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-07-19
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S006)MicroVention, Inc.2021-07-16
Senza Spinal Cord Stimulation (SCS) System (P130022/S039)Nevro Corporation2021-07-16
Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S007)MicroVention, Inc.2021-07-16
Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S003)MicroVention, Inc.2021-07-16
St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant (P150004/S048)ABBOTT MEDICAL2021-07-15
St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, St. Jude Medical In (P140009/S070)ABBOTT MEDICAL2021-07-15
Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S495)Medtronic Neuromodulation2021-07-15
St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim XR 5 Implan (P010032/S177)ABBOTT MEDICAL2021-07-15
Surpass Evolve Flow Diverter System (P170024/S009)Stryker Neurovascular2021-07-12
Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon (P030017/S344)Boston Scientific Corp2021-07-12
Restore, Itrel, Synergy, Intellis, Vanta, Sequentia LT, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris (P840001/S491)Medtronic Neuromodulation2021-07-08
Optune System (P100034/S026)Novocure, GmbH2021-07-07
Spinal Cord Stimulation (SCS) System (P010032/S173)ABBOTT MEDICAL2021-07-02
Dorsal Root Ganglion (DRG) Stimulation System (P150004/S045)ABBOTT MEDICAL2021-07-02
Medtronic Deep Brain Stimulation Therapy System (P960009/S400)Medtronic, Inc.2021-06-30
Restore, Itrel, Synergy, Intellis , Vanta and Sequentia LT Spinal Cord Stimulation Systems and Pisces, Specify, and Vect (P840001/S493)Medtronic Neuromodulation2021-06-30
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S490)Medtronic Neuromodulation2021-06-25
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S401)Medtronic, Inc.2021-06-25
NextGen DRG Lead Kit and Accessories (P150004/S044)ABBOTT MEDICAL2021-06-22
Percept and Activa Deep Brain Stimulation Therapy Systems (P960009/S385)Medtronic, Inc.2021-06-09
Nevro Corp Senza Spinal Cord Stimulation (SCS) System (P130022/S029)Nevro Corporation2021-06-09
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Every clearance here is in the API, with alerts when new ones post.