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Neurology

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

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RecordFirmDate
Nevro Corp Senza Spinal Cord Stimulation System (P130022/S016)Nevro Corporation2017-10-06
Activa Deep Brain Stimulation Therapy System (P960009/S296)Medtronic, Inc.2017-10-06
Master Restore, Itrel, Synergy and Intellis; Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor (P840001/S379)Medtronic Neuromodulation2017-10-06
St. Jude Medical Infinity DBS System 4CH Lead & 8CH Directional Lead (P140009/S029)ABBOTT MEDICAL2017-10-04
VNS Therapy Model 3000 Programmer (P970003/S211)LivaNova USA, Inc.2017-10-03
VNS THERAPY SYSTEM (P970003/S210)LivaNova USA, Inc.2017-10-03
Axium Neurostimulator System (P150004/S008)ABBOTT MEDICAL2017-09-29
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S367)Medtronic Neuromodulation2017-09-26
Activa Deep Brain Stimulation Therapy System (P960009/S286)Medtronic, Inc.2017-09-26
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S375)Medtronic Neuromodulation2017-09-22
Activa Deep Brain Stimulation Therapy System (P960009/S295)Medtronic, Inc.2017-09-19
Master Restore, Intrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord (P840001/S378)Medtronic Neuromodulation2017-09-19
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S277)Boston Scientific Corp2017-09-08
Axium Neurostimulator System (P150004/S012)ABBOTT MEDICAL2017-09-06
Genesis And Eon Family Neurostimulation (IPG) Systems (P010032/S133)ABBOTT MEDICAL2017-09-06
Brio Neurostimulation System (P140009/S028)ABBOTT MEDICAL2017-09-06
Restore, Intrel and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S365)Medtronic Neuromodulation2017-09-01
Activa Deep Brain Stimulation Therapy System (P960009/S289)Medtronic, Inc.2017-09-01
Activa Deep Brain Stimulation Therapy System (P960009/S284)Medtronic, Inc.2017-09-01
Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu (P840001/S370)Medtronic Neuromodulation2017-08-31
Master Restore, Itrel and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc (P840001/S371)Medtronic Neuromodulation2017-08-31
Master Restore, Itrel and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc (P840001/S372)Medtronic Neuromodulation2017-08-31
Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, Precision Montage, MRI Spinal Cord Stimulator (P030017/S301)Boston Scientific Corp2017-08-31
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S270)Boston Scientific Corp2017-08-30
Axium Neurostimulator System (P150004/S007)ABBOTT MEDICAL2017-08-25
Cassette and Cassette Spacer (P150004/S013)ABBOTT MEDICAL2017-08-24
Activa Deep Brain Stimulation Therapy System (P960009/S288)Medtronic, Inc.2017-08-24
Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu (P840001/S369)Medtronic Neuromodulation2017-08-24
Activa Deep Brain Stimulation Therapy System (P960009/S290)Medtronic, Inc.2017-08-24
DuraSeal TM Dural Sealant System (P040034/S026)Integra LifeSciences Corporation2017-08-17
Activa Deep Brain Stimulation Therapy System (P960009/S285)Medtronic, Inc.2017-08-16
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S366)Medtronic Neuromodulation2017-08-16
NeuroPace RNS System (P100026/S047)NeuroPace, Inc.2017-08-14
VNS Therapy System (P970003/S213)LivaNova USA, Inc.2017-08-11
PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems (P030017/S275)Boston Scientific Corp2017-08-11
Senza Spinal Cord Stimulation (SCS) System (P130022/S015)Nevro Corporation2017-08-09
Activa Deep Brain Stimulation Therapy System (P960009/S287)Medtronic, Inc.2017-08-08
Restore Itrel and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads. (P840001/S368)Medtronic Neuromodulation2017-08-08
Precision Spectra Wavewriter Spinal Cord Stimulatror (SCS) System (P030017/S291)Boston Scientific Corp2017-08-03
DBS Extensions (P140009/S025)ABBOTT MEDICAL2017-07-24
Proclaim Family of Implantable Pulse Generators; St.Jude Medical External Pulse Generator, Clinical Programmer and Patie (P010032/S125)ABBOTT MEDICAL2017-07-21
Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, 44, S-4, S-8, 88, winged, Penta, Quattrode, Octrode, Dual 4, Sin (P010032/S130)ABBOTT MEDICAL2017-07-21
Precision Montage (MRI) Spinal COrd Stimulation (SCS) System (P030017/S299)Boston Scientific Corp2017-07-19
Precision Spectra / Novi / Wavewriter Spinal Cord Stimulator (SCS) System, Precision Montage Spinal Cord Stimulator (SCS (P030017/S298)Boston Scientific Corp2017-07-12
Intellis(TM) Implantable Neurostimulation System (P840001/S344)Medtronic Neuromodulation2017-07-11
Codman Trufill N-Butyl Cyanoacrylate Liquid Embolic System (P990040/S025)Cerenovus, Inc.2017-07-05
Axium Leads and other accessories (P150004/S005)ABBOTT MEDICAL2017-07-03
Trim Change (P010032/S129)ABBOTT MEDICAL2017-06-28
Axium Neurostimulator System (P150004/S010)ABBOTT MEDICAL2017-06-28
BRIO NEUROSTIMULATION SYSTEM (P140009/S024)ABBOTT MEDICAL2017-06-28
ExAblate (P150038/S003)Insightec2017-06-26
VNS THERAPY SYSTEM (P970003/S207)LivaNova USA, Inc.2017-06-23
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S364)Medtronic Neuromodulation2017-06-21
Precision Spectra Spinal Cord Stimulator (SCS) System (P030017/S294)Boston Scientific Corp2017-06-21
Activa Deep Brain Stimulation Therapy System (P960009/S283)Medtronic, Inc.2017-06-21
Spinal Cord Stimulator External Pulse Generator (P010032/S128)ABBOTT MEDICAL2017-06-21
Precision Montage and Precision Montage MRI Spinal Cord Stimulator System (P030017/S293)Boston Scientific Corp2017-06-21
Precision Spectra and Spectra WaveWriter Spinal Cord Stimulator (P030017/S292)Boston Scientific Corp2017-06-19
Activa Deep Brain Stimualtion Therapy System (DBS) (P960009/S282)Medtronic, Inc.2017-06-15
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S363)Medtronic Neuromodulation2017-06-15
VNS THERAPY SYSTEM (P970003/S205)LivaNova USA, Inc.2017-06-06
Precision Novi Spinal Cord Stimulator (SCS) System (P030017/S287)Boston Scientific Corp2017-06-06
Adherus AutoSpray Dural Sealant (P130014/S004)Stryker Leibinger GmbH & Co KG2017-06-02
Precision Spinal Cord Stimulation (SCS) System (P030017/S288)Boston Scientific Corp2017-06-01
PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM (P030017/S269)Boston Scientific Corp2017-05-31
Activa Deep Brain Stimulation Therapy System (P960009/S281)Medtronic, Inc.2017-05-25
Restore, Itrel and Synergy Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord Stimulation Lead (P840001/S361)Medtronic Neuromodulation2017-05-25
Activa Deep Brain Stimulation Therapy System. (P960009/S280)Medtronic, Inc.2017-05-25
Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads (P840001/S362)Medtronic Neuromodulation2017-05-25
Algovita Spinal Cord Stimulation System (P130028/S017)Nuvectra Corporation2017-05-24
Restore, Itrel, Spinal Cord Stimulation Systems (P840001/S360)Medtronic Neuromodulation2017-05-23
Activa Deep Brain Stimulation Therapy System (P960009/S279)Medtronic, Inc.2017-05-23
Restore Spinal Cord Stimulation Systems (P840001/S359)Medtronic Neuromodulation2017-05-19
Activa Deep Brain Stimulation Therapy System (P960009/S278)Medtronic, Inc.2017-05-19
PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S273)Boston Scientific Corp2017-05-12
Algovita Spinal Cord Stimulation System (P130028/S014)Nuvectra Corporation2017-05-12
Activa Deep Brain Stimulation Therapy System (P960009/S277)Medtronic, Inc.2017-05-11
Spectra WaveWriter Spinal Cord Stimulator System (P030017/S290)Boston Scientific Corp2017-05-11
Restore and Itrel Spinal Cord Stimulation Systems (P840001/S358)Medtronic Neuromodulation2017-05-11
TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM (P990040/S024)Cerenovus, Inc.2017-05-11
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S289)Boston Scientific Corp2017-05-10
Precision Montage MRI and Precision Montage Spinal Cord Stimulator (SCS)Systems (P030017/S281)Boston Scientific Corp2017-05-08
Activa Deep Brain Stimulation Therapy System (P960009/S276)Medtronic, Inc.2017-05-03
Restore and Itrel Spinal Cord Stimulation Systems (P840001/S357)Medtronic Neuromodulation2017-05-03
Axium Neurostimulator System (P150004/S009)ABBOTT MEDICAL2017-05-03
NeuroPace RNS System (P100026/S049)NeuroPace, Inc.2017-05-02
Infinity Neurostimulation System (P140009/S023)ABBOTT MEDICAL2017-05-01
VNS THERAPY SYSTEM (P970003/S198)LivaNova USA, Inc.2017-04-28
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S278)Boston Scientific Corp2017-04-28
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S355)Medtronic Neuromodulation2017-04-26
Activa Deep Brain Stimulation Therapy System (P960009/S274)Medtronic, Inc.2017-04-26
Restore Spinal Cord Stimulation Systems (P840001/S356)Medtronic Neuromodulation2017-04-25
Activa Deep Brain Stimulation Therapy System (P960009/S275)Medtronic, Inc.2017-04-25
EXABLATE (P150038/S002)Insightec2017-04-17
NeuroPace RNS System (P100026/S048)NeuroPace, Inc.2017-04-05
Master Itrel Spinal Cord Stimulation System (P840001/S354)Medtronic Neuromodulation2017-04-04
Activa Deep Brain Stimulation Therapy System (P960009/S272)Medtronic, Inc.2017-04-04
Algovita Spinal Cord Stimulation System (P130028/S015)Nuvectra Corporation2017-03-31
Activa Deep Brain Stimulation Therapy System (P960009/S273)Medtronic, Inc.2017-03-31
Algovita Spinal Cord Stimulation System (P130028/S016)Nuvectra Corporation2017-03-30
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