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Neurology

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

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RecordFirmDate
Precision Spinal Cord Stimulator (SCS)System (P030017/S286)Boston Scientific Corp2017-03-28
Precision Montage and Precision Montage MRI (P030017/S284)Boston Scientific Corp2017-03-24
Precision Montage MRI Spinal Cord Stimulator (SCS)System; Precision Montage Spinal Cord Stimulator (SCS)System; Precisio (P030017/S285)Boston Scientific Corp2017-03-24
Activa Deep Brain Stimulation Therapy System (P960009/S271)Medtronic, Inc.2017-03-23
PRECISION, PRECISION SPECTRA, PRECISION NOVI, PRECISION MONTAGE, AND PRECISION MONTAGE MRI SCS SYSTEMS (P030017/S274)Boston Scientific Corp2017-03-23
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S353)Medtronic Neuromodulation2017-03-23
Precision Spinal Cord Stimulation SCS) System (P030017/S282)Boston Scientific Corp2017-03-22
Precision Spinal Cord Stimulation (SCS) System (P030017/S283)Boston Scientific Corp2017-03-20
Novocure Ltd.'s Optune (P100034/S017)Novocure, GmbH2017-03-15
SPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM (P030017/S271)Boston Scientific Corp2017-03-13
NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S012)Nevro Corporation2017-03-01
VNS THERAPY SYSTEM (P970003/S209)LivaNova USA, Inc.2017-02-16
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S276)Boston Scientific Corp2017-02-14
ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S013)Nuvectra Corporation2017-02-07
RESTORE ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S352)Medtronic Neuromodulation2017-02-07
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S270)Medtronic, Inc.2017-02-06
RESTORE ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S351)Medtronic Neuromodulation2017-02-06
LGW (P010032/S127)ABBOTT MEDICAL2017-02-03
MHY (P140009/S022)ABBOTT MEDICAL2017-02-03
PMP (P150004/S006)ABBOTT MEDICAL2017-02-03
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S350)Medtronic Neuromodulation2017-01-26
SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY (P840001/S349)Medtronic Neuromodulation2017-01-26
DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S268)Medtronic, Inc.2017-01-26
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S269)Medtronic, Inc.2017-01-26
ONYX LIQUID EMBOLIC SYSTEM (P030004/S012)Ev3 Neurovascular2017-01-25
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S266)Boston Scientific Corp2017-01-25
VNS THERAPY SYSTEM (P970003/S208)LivaNova USA, Inc.2017-01-18
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S272)Boston Scientific Corp2017-01-17
NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S011)Nevro Corporation2017-01-17
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S009)Nevro Corporation2017-01-12
Prodigy Leads and Extension Insertion Tool (P010032/S124)ABBOTT MEDICAL2017-01-09
Infinity Lead and Extension Insertion Tool (P140009/S020)ABBOTT MEDICAL2017-01-09
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S010)Nevro Corporation2016-12-28
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S267)Medtronic, Inc.2016-12-22
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S348)Medtronic Neuromodulation2016-12-22
Activa Deep Brain Stimulation Therapy System (P960009/S266)Medtronic, Inc.2016-12-15
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Extensions, Specify, and Vectris Spinal (P840001/S347)Medtronic Neuromodulation2016-12-15
NEUROPACE RNS SYSTEM (P100026/S046)NeuroPace, Inc.2016-12-14
TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM (P990040/S023)Cerenovus, Inc.2016-12-14
SCS ACCESSORIES, SCS EXTENSIONS, SCS LEADS, SCS LEADS 1x8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS RESUME FAMILY, SCS (P840001/S346)Medtronic Neuromodulation2016-12-13
DBS Accessories DBS Extensions DBS Leads DBS Neurostimulators 37022 DBS Neurostimulators 37601,37602,37603,DBS Programmi (P960009/S265)Medtronic, Inc.2016-12-13
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S268)Boston Scientific Corp2016-12-06
PRECISION SPECTRA, PRECISION MONTAGE AND PRECISION MONTAGE MRI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S267)Boston Scientific Corp2016-12-06
NEUROPACE RNS SYSTEM (P100026/S045)NeuroPace, Inc.2016-12-06
DBS LEAD, DBS LEAD-REDUCED SPACING (P960009/S167)Medtronic, Inc.2016-12-06
NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator (P970003/S206)LivaNova USA, Inc.2016-12-06
PERCUTANEOUS EXTENSION KIT (P840001/S236)Medtronic Neuromodulation2016-12-06
EON MINI, PRODIGY AND BRIO CHARGING SYSTEMS (P010032/S126)ABBOTT MEDICAL2016-12-01
BRIO NEUROSTIMULATION SYSTEM (P140009/S021)ABBOTT MEDICAL2016-12-01
Activa Deep Brain Stimulation Therapy System (P960009/S264)Medtronic, Inc.2016-11-28
DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS (P140009/S015)ABBOTT MEDICAL2016-11-28
SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS (P010032/S118)ABBOTT MEDICAL2016-11-28
Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Leads (P840001/S345)Medtronic Neuromodulation2016-11-28
PROCLAIM DORSAL ROOT GANGLION (DRG) NEUROSTIMULATION SYSTEM (P150004/S002)ABBOTT MEDICAL2016-11-28
PRECISION MONTAGE MRI AND SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S265)Boston Scientific Corp2016-11-24
VNS THERAPY SYSTEM (P970003/S195)LivaNova USA, Inc.2016-11-23
DEMIPULSE MODEL 103; ASPIREHC MODEL 105; ASPIRESR MODEL 106 GENERATOR. (P970003/S200)LivaNova USA, Inc.2016-11-23
PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S264)Boston Scientific Corp2016-11-23
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S007)Nevro Corporation2016-11-18
PRECISION SPECTRA, NOVI, MONTAGE MRI AND PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S263)Boston Scientific Corp2016-11-16
PRECISION NOVI MRI, SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S262)Boston Scientific Corp2016-11-16
NEUROPACE RNS SYSTEM (P100026/S044)NeuroPace, Inc.2016-11-16
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S260)Boston Scientific Corp2016-10-26
Precision, Precision Spectra, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) S (P030017/S261)Boston Scientific Corp2016-10-26
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S115)ABBOTT MEDICAL2016-10-18
PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM; MRI SPINAL CORD STIMULATOR (SCS) SYSTEM. (P030017/S255)Boston Scientific Corp2016-10-18
PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S259)Boston Scientific Corp2016-10-06
PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S258)Boston Scientific Corp2016-10-05
EON MINI LE CHARGING SYSTEM AND PRODIGY CHARGER SYSTEM (P010032/S122)ABBOTT MEDICAL2016-10-04
BRIO LE CHARGING SYSTEM (P140009/S019)ABBOTT MEDICAL2016-10-04
INFINITY FAMILY OF DBS IPGS AND DBS EPG (P140009/S010)ABBOTT MEDICAL2016-10-03
PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG (P010032/S109)ABBOTT MEDICAL2016-10-03
EXABLATE NEURO THALAMOTOMY (P150038/S001)Insightec2016-09-29
Precision Spectra & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S (P030017/S257)Boston Scientific Corp2016-09-29
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S343)Medtronic Neuromodulation2016-09-28
ONYX LIQUID EMBOLIC SYSTEM (P030004/S011)Ev3 Neurovascular2016-09-20
INFINITY NEUROSTIMULATION SYSTEM (P010032/S097)ABBOTT MEDICAL2016-09-19
INFINITY NEUROSTIMULATION SYSTEM (P140009/S001)ABBOTT MEDICAL2016-09-19
PRECISION, PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S256)Boston Scientific Corp2016-09-16
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S120)ABBOTT MEDICAL2016-09-15
BRIO NEUROSTIMULATION SYSTEM (P140009/S017)ABBOTT MEDICAL2016-09-15
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S342)Medtronic Neuromodulation2016-09-14
Activa Deep Brain Stimulation Therapy System (P960009/S263)Medtronic, Inc.2016-09-14
Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S341)Medtronic Neuromodulation2016-09-13
Activa Deep Brain Stimulation Therapy System (P960009/S262)Medtronic, Inc.2016-09-13
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S340)Medtronic Neuromodulation2016-09-09
ASPIRESR MODEL 106 GENERATOR (P970003/S204)LivaNova USA, Inc.2016-09-09
Activa Deep Brain Stimulation Therapy System (P960009/S261)Medtronic, Inc.2016-09-09
NEUROPACE RNS SYSTEM (P100026/S036)NeuroPace, Inc.2016-09-02
Restore, Itrel Spinal Cord Stimulation Systems (P840001/S339)Medtronic Neuromodulation2016-08-31
Activa Deep Brain Stimulation Therapy System (P960009/S260)Medtronic, Inc.2016-08-31
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S259)Medtronic, Inc.2016-08-25
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LE (P840001/S338)Medtronic Neuromodulation2016-08-25
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA (P840001/S337)Medtronic Neuromodulation2016-08-22
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S258)Medtronic, Inc.2016-08-22
ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S012)Nuvectra Corporation2016-08-19
AXIUM SHEATHS (P150004/S004)ABBOTT MEDICAL2016-08-18
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimul (P840001/S336)Medtronic Neuromodulation2016-08-18
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S241)Boston Scientific Corp2016-08-16
VNS THERAPY ASPRICE HC AND ASPIRESR, DEMIPULSE AND DEMIPULSE DUO, PULSE AND PULSE DUO GENERATORS; VNS THERAPY PERENNIAD (P970003/S202)LivaNova USA, Inc.2016-08-12
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