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Neurology

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

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RecordFirmDate
Deep Brain Stimulation (DBS) Therapy for Epilepsy (P960009/S351)Medtronic, Inc.2019-07-24
Onyx Liquid Embolic System (P030004/S020)Ev3 Neurovascular2019-07-24
Senza Spinal Cord Stimulation (SCS) System (P130022/S023)Nevro Corporation2019-07-18
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S152)ABBOTT MEDICAL2019-07-17
Pipeline Flex Embolization Device (P100018/S021)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-07-15
Genesis Neurostimulation System (P010032/S150)ABBOTT MEDICAL2019-07-15
Brio Neurostimulation System (P140009/S047)ABBOTT MEDICAL2019-07-15
DuraSeal Dural Sealant System (P040034/S029)Integra LifeSciences Corporation2019-07-11
DuraSeal Exact Spine Sealant System (P080013/S017)Integra LifeSciences Corporation2019-07-11
Activa Deep Brain Stimulation Therapy System (P960009/S352)Medtronic, Inc.2019-07-05
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S437)Medtronic Neuromodulation2019-07-05
Algovita Spinal Cord Stimulation System (P130028/S024)Nuvectra Corporation2019-07-03
Activa Deep Brain Stimulation Therapy System (P960009/S333)Medtronic, Inc.2019-07-03
Precision Spectra, Precision Novi, Precision Montage, and Precision Montage MRI, Spectra WaveWriter Spinal Cord Stimulat (P030017/S326)Boston Scientific Corp2019-07-02
Exablate Model 4000 System (P150038/S009)Insightec2019-06-28
NeuroPace RNS System (P100026/S072)NeuroPace, Inc.2019-06-24
Activa Deep Brain Stimulation Therapy System (P960009/S347)Medtronic, Inc.2019-06-24
NeuroPace RNS System (P100026/S066)NeuroPace, Inc.2019-06-19
NeuroPace RNS System (P100026/S071)NeuroPace, Inc.2019-06-17
Onyx Liquid Embolic System (P030004/S019)Ev3 Neurovascular2019-06-17
Activa Deep Brain Stimulation Therapy System (P960009/S322)Medtronic, Inc.2019-06-14
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify and Vectris Sprinal Cord Stimula (P840001/S405)Medtronic Neuromodulation2019-06-14
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S425)Medtronic Neuromodulation2019-06-12
Onyx Liquid Embolic System (P030004/S018)Ev3 Neurovascular2019-06-06
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S020)Boston Scientific Corp2019-06-05
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S436)Medtronic Neuromodulation2019-06-03
Activa Deep Brain Stimulation Therapy System (P960009/S350)Medtronic, Inc.2019-06-03
Implantable Pluse Generator (IPG): Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S016)Boston Scientific Corp2019-06-03
Implantable Pulse Generator (IPG) Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision (P030017/S324)Boston Scientific Corp2019-06-03
Algovita Spinal Cord Stimulation (SCS): 12-Electrode Percutaneous Leads, and Trial Leads (P130028/S023)Nuvectra Corporation2019-05-31
Activa Deep Brain Stimulation Therapy System (P960009/S349)Medtronic, Inc.2019-05-30
Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le (P840001/S435)Medtronic Neuromodulation2019-05-30
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S434)Medtronic Neuromodulation2019-05-24
Activa Deep Brain Stimulation Therapy System (P960009/S348)Medtronic, Inc.2019-05-24
NeuroPace RNS System (P100026/S068)NeuroPace, Inc.2019-05-24
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S433)Medtronic Neuromodulation2019-05-23
Pipeline Flex Embolization Device (P100018/S020)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-05-22
VNS Therapy System (P970003/S224)LivaNova USA, Inc.2019-05-22
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal COrd (P840001/S384)Medtronic Neuromodulation2019-05-20
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S432)Medtronic Neuromodulation2019-05-17
Neuroform Atlas® Stent System (P180031)Stryker Neurovascular2019-05-16
Activa Deep Brain Stimulation Therapy System (P960009/S303)Medtronic, Inc.2019-05-15
Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le (P840001/S431)Medtronic Neuromodulation2019-05-14
Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage (P030017/S323)Boston Scientific Corp2019-05-14
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S019)Boston Scientific Corp2019-05-03
Proclaim SCS Neurostimulation System FW (P010032/S148)ABBOTT MEDICAL2019-05-03
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S018)Boston Scientific Corp2019-05-02
Activa Deep Brain Stimulation Therapy System (P960009/S345)Medtronic, Inc.2019-05-01
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S428)Medtronic Neuromodulation2019-05-01
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S430)Medtronic Neuromodulation2019-04-29
Activa Deep Brain Stimulation Therapy System (P960009/S346)Medtronic, Inc.2019-04-29
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S429)Medtronic Neuromodulation2019-04-29
NeuroPace RNS System (P100026/S067)NeuroPace, Inc.2019-04-26
Exablate 4000 System (P150038/S011)Insightec2019-04-25
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Sysstems and Piseces, Specify and Vectris Spinal Cord Stimu (P840001/S426)Medtronic Neuromodulation2019-04-15
Activa Deep Brain Stimulation Therapy System (P960009/S344)Medtronic, Inc.2019-04-15
Optune System (P100034/S021)Novocure, GmbH2019-04-12
NeuroPace RNS System (P100026/S065)NeuroPace, Inc.2019-04-09
Vercise Vercise PC, and Vercise Gevia, Deep Brain Stimulation (DBS) Systems (P150031/S017)Boston Scientific Corp2019-04-05
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spexctra WaveWriter Spinal Co (P030017/S325)Boston Scientific Corp2019-04-05
Activa Deep Brain Stimulation Therapy System (P960009/S343)Medtronic, Inc.2019-04-02
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S424)Medtronic Neuromodulation2019-04-02
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S423)Medtronic Neuromodulation2019-04-01
Activa Deep Brain Stimulation Therapy System (P960009/S342)Medtronic, Inc.2019-04-01
SenTiva Model 1000 Generator (P970003/S221)LivaNova USA, Inc.2019-03-27
SCS EPG Header (P010032/S147)ABBOTT MEDICAL2019-03-26
Axium Neurostimulator System (P150004/S023)ABBOTT MEDICAL2019-03-26
Activa Deep Brain Stimulation Therapy System (P960009/S340)Medtronic, Inc.2019-03-22
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S421)Medtronic Neuromodulation2019-03-22
Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S027)Cerenovus, Inc.2019-03-22
Vercise, Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S015)Boston Scientific Corp2019-03-19
Activa Deep Brain Stimulation Therapy System (P960009/S339)Medtronic, Inc.2019-03-15
Itrel and Intellis Spinal Cord Stimulation Systems (P840001/S420)Medtronic Neuromodulation2019-03-14
Activa Deep Brain Stimulation Therapy System (P960009/S338)Medtronic, Inc.2019-03-14
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S014)Boston Scientific Corp2019-03-14
LGW- Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal (P840001/S406)Medtronic Neuromodulation2019-03-13
Multilead Trial Cable (MLTC) (P140009/S045)ABBOTT MEDICAL2019-03-13
Activa Deep Brain Stimulation Therapy System (P960009/S324)Medtronic, Inc.2019-03-13
Vercise PC Deep and Vercise Geviarn Deep Brain Stimulation (DBS) Systems (P150031/S013)Boston Scientific Corp2019-03-13
VNS Therapy System (P970003/S223)LivaNova USA, Inc.2019-03-12
Precision Spectra Spinal Cord Stimulatory (SCS) Sytem; Spectra WaveWriter Spinal Cord Stimulator (SCS) System; Precision (P030017/S322)Boston Scientific Corp2019-03-11
Activa Deep Brain Stimulation Therapy System (P960009/S337)Medtronic, Inc.2019-03-08
Master Restore, Itrel, Synergy and IntellisM Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor (P840001/S419)Medtronic Neuromodulation2019-03-08
Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S012)Boston Scientific Corp2019-03-07
Activa Deep Brain Stimulation Therapy System (P960009/S336)Medtronic, Inc.2019-03-01
Optune System (P100034/S022)Novocure, GmbH2019-02-28
4CH & 8CH Infinity DBS System FLex Extension (P140009/S038)ABBOTT MEDICAL2019-02-14
VNS Therapy System (P970003/S222)LivaNova USA, Inc.2019-02-14
Activa Deep Brain Stimulation Therapy System (P960009/S332)Medtronic, Inc.2019-02-12
Senza Spinal Cord Stimulation (SCS) System (P130022/S019)Nevro Corporation2019-02-08
VNS Therapy System (P970003/S219)LivaNova USA, Inc.2019-02-01
Vercise PC/Gevia DBS System (P150031/S002)Boston Scientific Corp2019-01-18
Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters (P010032/S146)ABBOTT MEDICAL2019-01-16
Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters (P140009/S044)ABBOTT MEDICAL2019-01-16
Vercise PC DBS System / Vercise Gevia DBS System (P150031/S001)Boston Scientific Corp2019-01-10
Activa Deep Brain Stimulation Therapy System (P960009/S334)Medtronic, Inc.2019-01-08
Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le (P840001/S417)Medtronic Neuromodulation2019-01-08
Activa Deep Brian Stimulation Therapy System (P960009/S335)Medtronic, Inc.2019-01-08
Restore, Itrel, Synergy and Intellis. Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Simul (P840001/S418)Medtronic Neuromodulation2019-01-08
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032)MicroVention, Inc.2018-12-31
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