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Neurology

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

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RecordFirmDate
Master Restore, Itrel, Synergy snd Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S396)Medtronic Neuromodulation2018-05-24
Algovita Spinal Cord Stimulation System (P130028/S020)Nuvectra Corporation2018-05-21
DRG Lead Extension Kit, SlimTip DRG Trial/Implant Lead Kit (P150004/S022)ABBOTT MEDICAL2018-05-19
NeuroPace RNS System (P100026/S054)NeuroPace, Inc.2018-05-16
Restore, Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stim (P840001/S395)Medtronic Neuromodulation2018-05-11
Activa Deep Brain Stimulation Therapy System (P960009/S312)Medtronic, Inc.2018-05-11
Exablate 4000 System (P150038/S007)Insightec2018-05-09
MEDTRONIC DBS THERAPY FOR EPILEPSY (P960009/S219)Medtronic, Inc.2018-04-27
Precision Spinal Cord Stimulator System (P030017/S313)Boston Scientific Corp2018-04-26
ITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S311)Medtronic Neuromodulation2018-04-26
Vercise DBS System (P150031/S003)Boston Scientific Corp2018-04-24
Activa Deep Brain Stimulation Therapy System (P960009/S311)Medtronic, Inc.2018-04-20
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S394)Medtronic Neuromodulation2018-04-20
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S (P840001/S377)Medtronic Neuromodulation2018-04-13
Activa Deep Brain Stimulation Therapy System (P960009/S294)Medtronic, Inc.2018-04-13
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S392)Medtronic Neuromodulation2018-04-13
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S393)Medtronic Neuromodulation2018-04-13
Active Deep Brain Stimulation Therapy System (P960009/S310)Medtronic, Inc.2018-04-09
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S391)Medtronic Neuromodulation2018-04-09
Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System (P030017/S312)Boston Scientific Corp2018-04-02
DuraSeal Exact Spine Sealant System (P080013/S015)Integra LifeSciences Corporation2018-03-21
DuraSeal Dural Sealant System (P040034/S027)Integra LifeSciences Corporation2018-03-21
Senza Spinal Cord Stimulation (SCS) System (P130022/S014)Nevro Corporation2018-03-21
Senza Spinal Cord Stimulation (SCS) System (P130022/S017)Nevro Corporation2018-03-19
Legacy MDT Pocket Adapter (P140009/S034)ABBOTT MEDICAL2018-03-14
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S311)Boston Scientific Corp2018-03-12
Precision Montage MRI Spinal Cord Stimulator System (P030017/S308)Boston Scientific Corp2018-03-12
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula (P840001/S376)Medtronic Neuromodulation2018-03-11
Infinity Family of Implantable Pulse Generators (P140009/S027)ABBOTT MEDICAL2018-03-11
Proclaim Family of Implantable Pulse Generators (P010032/S132)ABBOTT MEDICAL2018-03-11
Activa Deep Brain Stimulation Therapy System (P960009/S293)Medtronic, Inc.2018-03-11
NeuroPace RNS System (P100026/S053)NeuroPace, Inc.2018-02-20
VNS Therapy System (P970003/S215)LivaNova USA, Inc.2018-02-14
SCS Accessory and A127 Extension Kits (P010032/S137)ABBOTT MEDICAL2018-02-13
Onyx Liquid Embolic System (P030004/S014)Ev3 Neurovascular2018-02-06
Precision Novi Spinal Cord Stimulator (SCS) System Flash Memory Component Update (P030017/S307)Boston Scientific Corp2018-02-05
Precision Spectra Spinal Cord Stimulator (SCS) System (P030017/S306)Boston Scientific Corp2018-01-31
VNS Therapy System (P970003/S216)LivaNova USA, Inc.2018-01-24
DuraSeal Exact Spine Sealant System 3mL & 5mL (P080013/S014)Integra LifeSciences Corporation2018-01-24
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S310)Boston Scientific Corp2018-01-19
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S300)Boston Scientific Corp2018-01-19
Precision WaveWriter Spinal Cord Stimulator (SCS) System / WaveWriter IPG Test Equipment System (P030017/S309)Boston Scientific Corp2018-01-17
SCS and DBS Leads, Extensions, Anchors, Adapters and Accessories (P010032/S139)ABBOTT MEDICAL2018-01-12
Implantable Pulse Generators (P140009/S033)ABBOTT MEDICAL2018-01-12
Master Intellis Spinal Cord Stimulation System (P840001/S387)Medtronic Neuromodulation2018-01-11
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S389)Medtronic Neuromodulation2018-01-11
Activa Deep Brain Stimulation Therapy System (P960009/S308)Medtronic, Inc.2018-01-11
Proclaim Elite IPG (P010032/S140)ABBOTT MEDICAL2018-01-10
Infinity IPG (P140009/S035)ABBOTT MEDICAL2018-01-10
Proclaim DRG IPG (P150004/S019)ABBOTT MEDICAL2018-01-10
NeuroPace RNS System (P100026/S051)NeuroPace, Inc.2018-01-09
Activa Deep Brain Stimulation Therapy System (P960009/S307)Medtronic, Inc.2018-01-09
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula (P840001/S388)Medtronic Neuromodulation2018-01-09
NeuroPace RNS System (P100026/S052)NeuroPace, Inc.2018-01-08
Nevro Corp. Senza Spinal Cord Stimulation (SCS) System (P130022/S013)Nevro Corporation2018-01-04
VNS Therapy System (P970003/S214)LivaNova USA, Inc.2017-12-27
Spectra WaveWriter Spinal Cord Stimulator System (P030017/S302)Boston Scientific Corp2017-12-22
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S297)Boston Scientific Corp2017-12-21
SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit. (P150004/S017)ABBOTT MEDICAL2017-12-15
Spinal Cord Stimulation Leads; Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems adn Pisces, S (P840001/S385)Medtronic Neuromodulation2017-12-14
Activa Deep Brain Stimulation Therapy System (P960009/S305)Medtronic, Inc.2017-12-14
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S383)Medtronic Neuromodulation2017-12-13
Activa Deep Brain Stimulation Therapy System (P960009/S302)Medtronic, Inc.2017-12-13
Activa Deep Brain Stimulation Therapy System (P960009/S306)Medtronic, Inc.2017-12-12
Master Restore, Itrel, and Intellis Spinal Cord Stimulation Systems (P840001/S386)Medtronic Neuromodulation2017-12-12
Infinity family of DBS IPGs (P140009/S030)ABBOTT MEDICAL2017-12-09
EonC and Eon Mini Neurostimulation System (P010032/S135)ABBOTT MEDICAL2017-12-09
NeuroPace RNS System (P100026/S050)NeuroPace, Inc.2017-12-09
Proclaim Elite family of SCS IPGs (P010032/S134)ABBOTT MEDICAL2017-12-09
Proclaim DRG family of DRG IPGs (P150004/S014)ABBOTT MEDICAL2017-12-09
Axium Clinical and Patient Programmers (P150004/S016)ABBOTT MEDICAL2017-12-08
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031)Boston Scientific Corp2017-12-08
Master Restore, Itrel and Intellis Spinal Cord Stimulation Systems adn Pisces, Specify, and Vectris Spinal COrd Stimulat (P840001/S382)Medtronic Neuromodulation2017-12-06
Activa Deep Brain Stimulation Therapy System (P960009/S301)Medtronic, Inc.2017-12-06
Spectra WaveWriter SCS System (P030017/S305)Boston Scientific Corp2017-12-01
Proclaim DRG Implantable Pulse Generator (P150004/S018)ABBOTT MEDICAL2017-11-28
Proclaim Family of Implantable Pulse Generators (P010032/S138)ABBOTT MEDICAL2017-11-28
Infinity Family of Implantable Pulse Generators (P140009/S032)ABBOTT MEDICAL2017-11-28
Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulato (P030017/S295)Boston Scientific Corp2017-11-22
Precision Spinal Cord/ Spectra/Novi Spinal Cord Stimulatior (SCS) System, Precision Montage MRI and Precision Montage Sp (P030017/S296)Boston Scientific Corp2017-11-22
Genesis IPG/Eon IPG/Eon C IPG/Eon Mini IPG/Protege IPG/Protege MRI IPG/Prodigy/Prodigy MRI IPG/Proclaim IPG/Port Plug Ac (P010032/S136)ABBOTT MEDICAL2017-11-21
Brio IPG/Infinity IPG (P140009/S031)ABBOTT MEDICAL2017-11-21
Activa Deep Brain Stimulation Therapy System (P960009/S292)Medtronic, Inc.2017-11-17
Restore, Itrel and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S374)Medtronic Neuromodulation2017-11-17
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces. Specify and Vectris Spinal Cord Stimula (P840001/S381)Medtronic Neuromodulation2017-11-16
Activa Deep Brain Stimulation Therapy System (P960009/S300)Medtronic, Inc.2017-11-16
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S280)Boston Scientific Corp2017-11-14
Activa Deep Brain Stimulation Therapy System (P960009/S299)Medtronic, Inc.2017-11-03
Restore, and Itrel Spinal Cord Stimulation Systems (P840001/S380)Medtronic Neuromodulation2017-11-03
Precision Montage MRI Spinal Cord Stimulator (SCS) Systems (P030017/S303)Boston Scientific Corp2017-10-31
Precision Montage MRI Spinal Cord Stimulator (SCS) Systems (P030017/S304)Boston Scientific Corp2017-10-31
Restore, ltrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces and Vectris Spinal Cord Stimulation Lead (P840001/S373)Medtronic Neuromodulation2017-10-26
Activa Deep Brain Stimulation Therapy System (P960009/S291)Medtronic, Inc.2017-10-26
Activa Deep Brain Stimulation Therapy System (P960009/S297)Medtronic, Inc.2017-10-20
Activa Deep Brain Stimulation Therapy System (P960009/S298)Medtronic, Inc.2017-10-18
Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight (P030004/S013)Ev3 Neurovascular2017-10-17
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S279)Boston Scientific Corp2017-10-17
ExAblate Neuro Thalamotomy (P150038/S004)Insightec2017-10-13
DRG Lead Extension Kit (P150004/S015)ABBOTT MEDICAL2017-10-13
Pipeline Flex Embolization Device (P100018/S016)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2017-10-11
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