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Neurology

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

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RecordFirmDate
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S341)Boston Scientific Corp2020-09-22
Pipeline Flex Embolization Device (P100018/S028)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-09-21
DuraSeal Exact Spine Sealant System (P080013/S021)Integra LifeSciences Corporation2020-09-16
DuraSeal Dural Sealant System (P040034/S032)Integra LifeSciences Corporation2020-09-16
Surpass Streamline Flow Diverter (P170024/S004)Stryker Neurovascular2020-09-14
Percept Deep Brain Stimulation Therapy System (P960009/S381)Medtronic, Inc.2020-09-11
Activa Deep Brain Stimulation Therapy System (P960009/S380)Medtronic, Inc.2020-09-09
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S467)Medtronic Neuromodulation2020-09-09
Activa Deep Brain Stimulation Therapy System (P960009/S379)Medtronic, Inc.2020-09-06
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S466)Medtronic Neuromodulation2020-09-06
Activa Deep Brain Stimulation Therapy System (P960009/S377)Medtronic, Inc.2020-08-21
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S167)ABBOTT MEDICAL2020-08-18
Neuroform Atlas Stent System (P180031/S003)Stryker Neurovascular2020-08-18
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S042)ABBOTT MEDICAL2020-08-18
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S063)ABBOTT MEDICAL2020-08-18
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S463)Medtronic Neuromodulation2020-08-17
DuraSeal Exact Spine Sealant System (P080013/S019)Integra LifeSciences Corporation2020-08-17
DuraSeal Dural Sealant System (P040034/S031)Integra LifeSciences Corporation2020-08-17
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S008)Stryker Leibinger GmbH & Co KG2020-08-14
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S038)Boston Scientific Corp2020-08-14
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S036)Boston Scientific Corp2020-08-12
Activa Deep Brain Stimulation Therapy Systems (P960009/S378)Medtronic, Inc.2020-08-12
Infinity Deep Brain Stimulation (DBS) System (P140009/S061)ABBOTT MEDICAL2020-08-12
Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Spectra Wave Write (P030017/S340)Boston Scientific Corp2020-08-11
Vercise Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S037)Boston Scientific Corp2020-08-11
NeuroPace RNS System (P100026/S082)NeuroPace, Inc.2020-08-04
Neuroform Atlas® Stent System (P180031/S001)Stryker Neurovascular2020-07-30
DuraSeal Exact Spine Sealant System (P080013/S020)Integra LifeSciences Corporation2020-07-22
Flow Re-Direction Endoluminal Device (FRED) System (P180027/S001)MicroVention, Inc.2020-07-17
NeuroPace RNS System (P100026/S083)NeuroPace, Inc.2020-07-14
NeuroPace RNS System (P100026/S081)NeuroPace, Inc.2020-07-14
Adherus AutoSpray ET Dural Sealant (P130014/S007)Stryker Leibinger GmbH & Co KG2020-07-10
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S427)Medtronic Neuromodulation2020-07-01
Infinity DBS IPG (P140009/S058)ABBOTT MEDICAL2020-07-01
Proclaim DRG IPG (P150004/S037)ABBOTT MEDICAL2020-07-01
Proclaim family of SCS IPG (P010032/S162)ABBOTT MEDICAL2020-07-01
Vercise Deep Brain Stimulation (DBS) System (P150031/S031)Boston Scientific Corp2020-06-29
Apollo Onyx Delivery Micro Catheter (P030004/S024)Ev3 Neurovascular2020-06-29
Pipeline Flex Embolization Device (P100018/S027)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-06-29
Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S450)Medtronic Neuromodulation2020-06-25
Activia Deep Brain Stimulation Therapy System (P960009/S365)Medtronic, Inc.2020-06-25
(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems (P960009/S361)Medtronic, Inc.2020-06-24
ReActiv8 Implantable Neurostimulation System (P190021)Mainstay Medical Limited2020-06-16
Apollo Onyx Delivery Micro Catheter (P030004/S017)Ev3 Neurovascular2020-06-15
Activa Deep Brain Stimulation Therapy System (P960009/S375)Medtronic, Inc.2020-06-09
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S462)Medtronic Neuromodulation2020-06-09
Proclaim DRG IPG (P150004/S033)ABBOTT MEDICAL2020-06-05
Proclaim family of SCS IPGs (P010032/S156)ABBOTT MEDICAL2020-06-05
Infinity Family of DBS IPGs (P140009/S052)ABBOTT MEDICAL2020-06-05
Dorsal Root Ganglion (DRG) Stimulation (P150004/S039)ABBOTT MEDICAL2020-06-04
Deep Brain Stimulation (DBS) (P140009/S060)ABBOTT MEDICAL2020-06-04
Spinal Cord Stimulation (SCS) (P010032/S164)ABBOTT MEDICAL2020-06-04
Deep Brain Stimulation Therapy (P140009/S059)ABBOTT MEDICAL2020-05-30
Dorsal Root Ganglion Stimulator for Pain Relief (P150004/S038)ABBOTT MEDICAL2020-05-30
Totally Implanted Spinal Cord Stimulator for Pain Relief (P010032/S163)ABBOTT MEDICAL2020-05-30
VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S035)Boston Scientific Corp2020-05-27
Precision Spinal Cord Stimulator(SCS) Systems (P030017/S339)Boston Scientific Corp2020-05-27
Senza Spinal Cord Stimulation (SCS) System (P130022/S033)Nevro Corporation2020-05-26
Surpass Evolve Flow Diverter System (P170024/S003)Stryker Neurovascular2020-05-20
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S033)Boston Scientific Corp2020-05-15
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S337)Boston Scientific Corp2020-05-15
VNS Therapy System (P970003/S231)LivaNova USA, Inc.2020-05-13
Precision Spinal Cord Stimulator (SCS) Systems, (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montag (P030017/S336)Boston Scientific Corp2020-05-13
Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia) (P150031/S032)Boston Scientific Corp2020-05-13
Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S461)Medtronic Neuromodulation2020-05-08
Activa Deep Brain Stimulation Therapy System (P960009/S374)Medtronic, Inc.2020-05-08
Activa Deep Brain Stimulation Therapy System (P960009/S373)Medtronic, Inc.2020-05-07
Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stimu (P840001/S460)Medtronic Neuromodulation2020-05-07
Proclaim family of SCS IPGs (P010032/S160)ABBOTT MEDICAL2020-05-06
Proclaim DRG IPG (P150004/S035)ABBOTT MEDICAL2020-05-06
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S036)ABBOTT MEDICAL2020-05-06
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S161)ABBOTT MEDICAL2020-05-06
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S057)ABBOTT MEDICAL2020-05-06
Infinity DBS IPGs (P140009/S056)ABBOTT MEDICAL2020-05-06
Algovita Spinal Cord Stimulation System (P130028/S031)Nuvectra Corporation2020-05-05
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S006)MicroVention, Inc.2020-04-28
Senza Spinal Cord Stimulation (SCS) System (P130022/S028)Nevro Corporation2020-04-25
Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai (P150031/S030)Boston Scientific Corp2020-04-24
Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi™ (P030017/S335)Boston Scientific Corp2020-04-24
Activa Deep Brain Stimulation Therapy System (P960009/S372)Medtronic, Inc.2020-04-22
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S459)Medtronic Neuromodulation2020-04-22
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, and Spectra WaveWriter Spinal Co (P030017/S334)Boston Scientific Corp2020-04-17
ExAblate 4000 System (Exablate Neuro or the system) (P150038/S012)Insightec2020-04-14
Vercise PC and Vercise Gevia DBS Systems (P150031/S026)Boston Scientific Corp2020-04-10
DuraSeal Exact System (P080013/S018)Integra LifeSciences Corporation2020-04-08
DuraSeal Dural Sealant System (P040034/S030)Integra LifeSciences Corporation2020-04-08
Activa Deep Brain Stimulation Therapy System (P960009/S371)Medtronic, Inc.2020-04-07
Restore,Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimula (P840001/S458)Medtronic Neuromodulation2020-04-07
NeuroPace RNS System (P100026/S080)NeuroPace, Inc.2020-04-06
Senza Spinal Cord Stimulation (SCS) System (P130022/S031)Nevro Corporation2020-04-02
Activa Deep Brain Stimulation Therapy System (P960009/S370)Medtronic, Inc.2020-03-27
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S457)Medtronic Neuromodulation2020-03-27
VNS Therapy System (P970003/S232)LivaNova USA, Inc.2020-03-26
Activa Deep Brain Stimulation Therapy System (P960009/S369)Medtronic, Inc.2020-03-20
VNS Therapy System (P970003/S225)LivaNova USA, Inc.2020-03-20
NeuroPace RNS System (P100026/S079)NeuroPace, Inc.2020-03-20
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S456)Medtronic Neuromodulation2020-03-20
Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co (P030017/S333)Boston Scientific Corp2020-03-17
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S029)Boston Scientific Corp2020-03-17
Optune System (P100034/S023)Novocure, GmbH2020-03-15
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