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Neurology

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

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RecordFirmDate
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S159)ABBOTT MEDICAL2020-03-04
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S055)ABBOTT MEDICAL2020-03-04
Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S455)Medtronic Neuromodulation2020-03-01
Apollo Onyx Delivery Micro Catheter (P030004/S023)Ev3 Neurovascular2020-02-28
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S454)Medtronic Neuromodulation2020-02-20
NeuroPace RNS System (P100026/S069)NeuroPace, Inc.2020-02-20
Algovita Spinal Cord Stimulation System (P130028/S028)Nuvectra Corporation2020-02-12
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S003)MicroVention, Inc.2020-02-07
Activa Deep Brain Stimulation Therapy System (P960009/S368)Medtronic, Inc.2020-02-05
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S453)Medtronic Neuromodulation2020-02-05
VNS Therapy System (P970003/S228)LivaNova USA, Inc.2020-01-31
Activa Deep Brain Stimulation Therapy System (P960009/S363)Medtronic, Inc.2020-01-29
VNS Therapy System (P970003/S230)LivaNova USA, Inc.2020-01-29
Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co (P030017/S331)Boston Scientific Corp2020-01-24
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S005)MicroVention, Inc.2020-01-23
NeuroPace RNS System (P100026/S078)NeuroPace, Inc.2020-01-22
Neuroform Atlas® Stent System (P180031/S002)Stryker Neurovascular2020-01-18
VNS Therapy System (P970003/S229)LivaNova USA, Inc.2020-01-13
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG (P010032/S158)ABBOTT MEDICAL2020-01-10
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG. (P150004/S034)ABBOTT MEDICAL2020-01-10
Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG (P140009/S054)ABBOTT MEDICAL2020-01-10
Activa Deep Brain Stimulation Therapy System (P960009/S366)Medtronic, Inc.2020-01-09
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation systems, and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S452)Medtronic Neuromodulation2020-01-09
Activia Deep Brain Stimulation Therapy System (P960009/S367)Medtronic, Inc.2020-01-09
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S451)Medtronic Neuromodulation2020-01-09
St. Jude Medical Infinity DBS Implantable Pulse Generator (P140009/S039)ABBOTT MEDICAL2020-01-02
Algovita Spinal Cord Stimulation System (P130028/S025)Nuvectra Corporation2019-12-31
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S447)Medtronic Neuromodulation2019-12-26
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S449)Medtronic Neuromodulation2019-12-19
Active Deep Brain Stimulation Therapy System (P960009/S364)Medtronic, Inc.2019-12-19
Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter (P030004/S022)Ev3 Neurovascular2019-12-19
Senza spinal Cord Stimulation (SCS) System (P130022/S024)Nevro Corporation2019-12-18
NeuroPace RNS System (P100026/S075)NeuroPace, Inc.2019-12-17
Flow Re-Direction Endoluminal Device (FRED®) System (P180027)MicroVention, Inc.2019-12-16
Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S448)Medtronic Neuromodulation2019-12-11
Activa Deep Brain Stimulation Therapy System (P960009/S362)Medtronic, Inc.2019-12-11
Apollo Onyx Delivery Microcatheter (P030004/S021)Ev3 Neurovascular2019-12-10
Pipeline Flex Embolization Device (P100018/S022)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-12-10
Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Co (P030017/S332)Boston Scientific Corp2019-12-05
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S027)Boston Scientific Corp2019-12-04
Senza Spinal Cord Stimulation (SCS) System (P130022/S022)Nevro Corporation2019-11-22
Axium Neurostimulator System (P150004/S032)ABBOTT MEDICAL2019-11-19
Genesis Neurostimulation System (P010032/S155)ABBOTT MEDICAL2019-11-19
Brio Neurostimulation System (P140009/S051)ABBOTT MEDICAL2019-11-19
Senza Spinal Cord Stimulation (SCS) System (P130022/S027)Nevro Corporation2019-11-08
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S422)Medtronic Neuromodulation2019-11-06
Activa Deep Brain Stimulation Therapy System (P960009/S341)Medtronic, Inc.2019-11-06
NeuroPace RNS System (P100026/S076)NeuroPace, Inc.2019-11-05
Senza Spinal Cord Stimulation (SCS) System (P130022/S026)Nevro Corporation2019-10-25
Algovita Spinal Cord Stimulation System (P130028/S030)Nuvectra Corporation2019-10-25
Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S446)Medtronic Neuromodulation2019-10-24
Activa Deep Brain Stimulation Therapy System (P960009/S360)Medtronic, Inc.2019-10-24
VNS Therapy System (P970003/S227)LivaNova USA, Inc.2019-10-24
Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S445)Medtronic Neuromodulation2019-10-23
Vercise PC and Vercise Gevia Deep Brian Stimulation (DBS) System (P150031/S021)Boston Scientific Corp2019-10-20
Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulato (P030017/S328)Boston Scientific Corp2019-10-20
Senza Spinal Cord Stimulation (SCS) System (P130022/S021)Nevro Corporation2019-10-15
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S444)Medtronic Neuromodulation2019-10-13
Activa Deep Brain Stimulation Therapy System (P960009/S359)Medtronic, Inc.2019-10-13
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S002)MicroVention, Inc.2019-10-01
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify (P840001/S443)Medtronic Neuromodulation2019-09-27
8-Channel Adapters (P140009/S049)ABBOTT MEDICAL2019-09-26
Torque Wrench (P010032/S154)ABBOTT MEDICAL2019-09-26
Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage (P030017/S330)Boston Scientific Corp2019-09-24
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S024)Boston Scientific Corp2019-09-24
Pipeline Flex Embolization Device (P100018/S023)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-09-20
NeuroPace RNS System (P100026/S063)NeuroPace, Inc.2019-09-19
Algovita Spinal Cord Stimulation System (P130028/S029)Nuvectra Corporation2019-09-19
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S029)Cerenovus, Inc.2019-09-18
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S006)Stryker Leibinger GmbH & Co KG2019-09-18
Activa Deep Brain Stimulation Therapy System (P960009/S358)Medtronic, Inc.2019-09-17
Infinity family of DBS IPGs (P140009/S046)ABBOTT MEDICAL2019-09-17
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S442)Medtronic Neuromodulation2019-09-17
Proclaim family of SCS IPGs (P010032/S149)ABBOTT MEDICAL2019-09-17
Proclaim DRG IPG Clinical Programmer App (P150004/S029)ABBOTT MEDICAL2019-09-17
Implantable Pulse Generator (IPG), Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precisi (P030017/S329)Boston Scientific Corp2019-09-13
Precision Spectra and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems (P030017/S327)Boston Scientific Corp2019-09-13
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S023)Boston Scientific Corp2019-09-12
Proclaim Spinal Cord Stimulation (SCS) IPG Family (P010032/S151)ABBOTT MEDICAL2019-09-09
VNS Therapy System (P970003/S226)LivaNova USA, Inc.2019-09-05
Infinity Deep Brain Stimulation (DBS) System (P140009/S050)ABBOTT MEDICAL2019-09-05
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S022)Boston Scientific Corp2019-09-04
Deep Brain Stimulation Therapy System for Parkinson's Disease (P960009/S357)Medtronic, Inc.2019-09-04
Algovita Spinal Cord Stimulation System (P130028/S027)Nuvectra Corporation2019-08-28
NeuroPac RNS System (P100026/S074)NeuroPace, Inc.2019-08-26
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S441)Medtronic Neuromodulation2019-08-22
Activa Deep Brain Stimulation Therapy System (P960009/S356)Medtronic, Inc.2019-08-22
Vercise Gevia DBS System and Directional Lead-only System (P150031/S011)Boston Scientific Corp2019-08-19
Senza Spinal Cord Stimulation (SCS) System (P130022/S025)Nevro Corporation2019-08-18
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S (P840001/S439)Medtronic Neuromodulation2019-08-14
Activa Deep Brain Stimulation Therapy System (P960009/S354)Medtronic, Inc.2019-08-14
Algovita Spinal Cord Stimulation System (P130028/S026)Nuvectra Corporation2019-08-09
NeuroPace RNS System (P100026/S073)NeuroPace, Inc.2019-08-08
NeuroPace RNS System (P100026/S070)NeuroPace, Inc.2019-08-01
Axium Neurostimulator System (P150004/S030)ABBOTT MEDICAL2019-07-31
Axium Neurostimulator System (P150004/S031)ABBOTT MEDICAL2019-07-29
BRIO NEUROSTIMULATION SYSTEM (P140009/S048)ABBOTT MEDICAL2019-07-29
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S353)Medtronic, Inc.2019-07-29
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S438)Medtronic Neuromodulation2019-07-29
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S153)ABBOTT MEDICAL2019-07-29
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