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Neurology

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

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RecordFirmDate
NEURO PACE RNS SYSTEM (P100026/S005)NeuroPace, Inc.2014-02-18
PRECISION SPECTRA SYSTEM (P030017/S181)Boston Scientific Corp2014-02-16
NEUROPACE RNS SYSTEM (P100026/S006)NeuroPace, Inc.2014-02-14
NEUROPACE RNS SYSTEM (P100026/S008)NeuroPace, Inc.2014-02-14
NEUROPACE RNS SYSTEM (P100026/S003)NeuroPace, Inc.2014-02-07
DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S008)Integra LifeSciences Corporation2014-02-06
NEUROPACE RNS SYSTEM (P100026/S007)NeuroPace, Inc.2014-01-24
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S187)Boston Scientific Corp2014-01-22
DBS SYSTEMS (P960009/S187)Medtronic, Inc.2014-01-22
VECTRIS SURESCAN 1X8 LEADS (P840001/S259)Medtronic Neuromodulation2014-01-22
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S188)Boston Scientific Corp2014-01-22
MODEL 201 PROGRAMMING WAND (P970003/S167)LivaNova USA, Inc.2014-01-02
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S017)Cerenovus, Inc.2013-12-24
OLYMPIC COOL-CAP SYSTEM (P040025/S014)Natus Medical Incorporated2013-12-23
NEUROPACE RNS SYSTEM (P100026/S002)NeuroPace, Inc.2013-12-20
NEUROPACE RNS SYSTEM (P100026/S001)NeuroPace, Inc.2013-12-18
ACTIVA PC (P960009/S186)Medtronic, Inc.2013-12-13
RESTOREPRIME (P840001/S258)Medtronic Neuromodulation2013-12-13
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S184)Boston Scientific Corp2013-12-13
MRICS AND LZ OCTAD LEAD FAMILIES (P840001/S257)Medtronic Neuromodulation2013-12-12
DBS EXTENSIONS, DBS LEADS (P960009/S172)Medtronic, Inc.2013-12-11
SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X 8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY, SCS SCREENING TRAIL (P840001/S241)Medtronic Neuromodulation2013-12-11
PRECUSION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S183)Boston Scientific Corp2013-12-10
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S182)Boston Scientific Corp2013-12-04
VARIOUS FAMILIES OF SPINAL CORD STIMULATION SYSTEMS (P840001/S256)Medtronic Neuromodulation2013-11-27
VNS THERAPY SYSTEM (P970003/S146)LivaNova USA, Inc.2013-11-26
ACTIVA PC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR, ACTIVA SC IMPLANTABLE NEUROSTIMULATOR, (P960009/S185)Medtronic, Inc.2013-11-22
ITREL 4 IMPLANTABLE NEUROSTIMULATOR,ITREL 4 IMPLANTABLE NEUROSTIMULATOR,ITREL 3 IMPLANTABLE NEUROSTIMULATOR,RESTOREPRIME (P840001/S255)Medtronic Neuromodulation2013-11-22
SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY (P840001/S254)Medtronic Neuromodulation2013-11-20
DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S009)Integra LifeSciences Corporation2013-11-15
DURASEAL DURAL SEALANT SYSTEM (P040034/S021)Integra LifeSciences Corporation2013-11-15
NEUROPACE RNS SYSTEM (P100026)NeuroPace, Inc.2013-11-14
DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S184)Medtronic, Inc.2013-10-30
SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY (P840001/S253)Medtronic Neuromodulation2013-10-30
SCS PROGRAMMING SYSTEMS, N VISION PROGRAMMER (P840001/S250)Medtronic Neuromodulation2013-10-23
DBS PROGRAMMING SYSTEMS, N VISION PROGRAMMER, ACCESS THERAPY CONTROLLER, ACCESS REVIEW THERPY CONTROLLER (P960009/S181)Medtronic, Inc.2013-10-23
DBS ACCESSORIES; EXTENSION ;NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY; KINETRA FAMILY, DBS SCREEING SYSTEM (P960009/S182)Medtronic, Inc.2013-10-22
SCS ACCESSORIES (P840001/S251)Medtronic Neuromodulation2013-10-22
PIPELINE EMBOLIZATION DEVICE (P100018/S008)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2013-10-22
TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C (P010032/S067)ABBOTT MEDICAL2013-10-15
PRIMEADVANCED SURESCAN MRI NEUROSTIMULATOR,RESTOREULTRA SURESCAN MRI NEUROSTIMULATOR,RESTOREADVANCED SURESCAN MRI NEUROS (P840001/S249)Medtronic Neuromodulation2013-10-15
ITREL, RESTORE, SYNERGY, (P840001/S252)Medtronic Neuromodulation2013-10-10
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S248)Medtronic Neuromodulation2013-10-10
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S180)Medtronic, Inc.2013-10-10
ACTIVA, KINETRA, SOLETRA (P960009/S183)Medtronic, Inc.2013-10-10
ONYX 18LES & ONYX 34 LES (P030004/S008)Ev3 Neurovascular2013-10-09
SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY (P840001/S247)Medtronic Neuromodulation2013-10-03
DBS EXTENSIONS, DBS LEADS (P960009/S179)Medtronic, Inc.2013-10-03
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S179)Boston Scientific Corp2013-09-26
VNS THERAPY ACCESSORY PACK (P970003/S164)LivaNova USA, Inc.2013-09-23
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S177)Boston Scientific Corp2013-09-20
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S178)Boston Scientific Corp2013-09-20
NOVOTTF-100A SYSTEM (P100034/S006)Novocure, GmbH2013-09-19
MEDTRONIC DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S156)Medtronic, Inc.2013-09-13
DEMIPULSE AND DEMIPULSE DUO GENERATORS,ASPIREHC MODEL 105 GENERATOR (P970003/S165)LivaNova USA, Inc.2013-09-05
OLYMPIC COOL CAP (P040025/S013)Natus Medical Incorporated2013-08-29
EXTERNAL NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD STIMULATION,RESTOREPRIME NEUROSTIMULATOR, (P840001/S246)Medtronic Neuromodulation2013-08-27
EXTERNAL NEUROSTIMULATOR,ACTIVIA PC NEUROSTIMULATOR,ACTIVIA SC NEUROSTIMULATOR,ACTIVA RC NEUROSTIMULATOR (P960009/S178)Medtronic, Inc.2013-08-27
ACTIVA DBS LEAD, ACTIVA DBS LEAD REDUCED SPACING (P960009/S177)Medtronic, Inc.2013-08-27
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S176)Boston Scientific Corp2013-08-21
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S175)Boston Scientific Corp2013-08-16
SCS ACCESSORY KIT (P010032/S071)ABBOTT MEDICAL2013-08-15
VARIOUS MODELS OF THE ITREL 4, RESTORE, AND SURE SCAN MRI FAMILES OF IMPLANTABLE SPINAL CORD STIMULATORS (P840001/S245)Medtronic Neuromodulation2013-08-12
ACTIVA PC, SC, AND RC IMPLANTABLE DEEP BRAIN STIMULATORS (P960009/S176)Medtronic, Inc.2013-08-12
NOVOTTF-100A SYSTEM (P100034/S004)Novocure, GmbH2013-08-08
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S168)Boston Scientific Corp2013-08-06
DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY (P960009/S174)Medtronic, Inc.2013-08-02
SPINAL CORD STIMULATION (SCS) NEUROSTIMULATORS IMPLANTABLE (INS) RESTORE FAMILY (P840001/S243)Medtronic Neuromodulation2013-08-02
ACTIVA PC,SC,AND RC IMPLANTABLE DEEP BRAIN STIMULATORS (P960009/S175)Medtronic, Inc.2013-08-01
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S173)Boston Scientific Corp2013-08-01
VARIOUS MODELS OF THE ITREL 4, RESTORE, & SURE SCAN MRI FAMILIES OF IMPLANTABLE SPINAL CORD STIMULATORS (P840001/S244)Medtronic Neuromodulation2013-08-01
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S174)Boston Scientific Corp2013-07-31
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S172)Boston Scientific Corp2013-07-30
ONYX LIQUID EMBOLIC SYSTEM (LES) (P030004/S007)Ev3 Neurovascular2013-07-19
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S171)Boston Scientific Corp2013-07-19
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S170)Boston Scientific Corp2013-07-12
EONC 16-CHANNEL IPG NEUROSTIMULATION SYSTEM (P010032/S072)ABBOTT MEDICAL2013-07-12
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S169)Boston Scientific Corp2013-07-11
VNS THERAPY GENERATOR (DEMIPULSE) (ASPIREHC) (P970003/S162)LivaNova USA, Inc.2013-07-10
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S148)Boston Scientific Corp2013-06-28
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S050)ABBOTT MEDICAL2013-06-26
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S167)Boston Scientific Corp2013-06-20
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S166)Boston Scientific Corp2013-06-19
ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR AND EXTERNAL NEUROSTIMULATOR (P960009/S165)Medtronic, Inc.2013-06-19
RESTORE ULTRA NEUROSTIMULATOR, RESTORE SENSOR NEUROSTIMULATOR, ITREL 4 NEUROSTIMULATOR AND ENTERNAL NEUROSTIMULATOR (P840001/S234)Medtronic Neuromodulation2013-06-19
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S165)Boston Scientific Corp2013-06-19
ACTIVA DEPP BRAIN STIMULATION ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA (P960009/S166)Medtronic, Inc.2013-06-17
SPINAL CORD STIMULATION (ITREL SYNERGY, SYNERGY VERSITREL, RESTOREPRIME, RESTORE ADVANCED, PRIME ADVANCED RESTOR ULTRA, (P840001/S235)Medtronic Neuromodulation2013-06-17
NOVA TTF-100A SYSTEM (P100034/S005)Novocure, GmbH2013-06-12
PRIMEADVANCED SURESCAN MRI IMPLANTABLE NEUROSTIMULATOR (P840001/S240)Medtronic Neuromodulation2013-06-05
PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR(SCS)SYSTEM (P030017/S163)Boston Scientific Corp2013-06-04
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM,PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S164)Boston Scientific Corp2013-06-04
DEEP BRAIN STIMULATION (DBS) LEAD CAP (P960009/S170)Medtronic, Inc.2013-06-03
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S157)Boston Scientific Corp2013-05-30
DBS LEADS(DEEP BRAIN STIMULATION) (P960009/S171)Medtronic, Inc.2013-05-29
VNS THERAPY GENERATOR(PULSE AND PULSE DUO) (ASPIREHC) (P970003/S163)LivaNova USA, Inc.2013-05-21
EON MINI 2.0 SYSTEM (P010032/S068)ABBOTT MEDICAL2013-05-17
VECTRIS SURESCAN MRI 1X8 LEADS, VECTRIS 1X8 TRIALING LEADS (P840001/S239)Medtronic Neuromodulation2013-05-16
SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S238)Medtronic Neuromodulation2013-05-10
PIPELINE EMBOLIZATION DEVICE, PIPELINE EMBOLIZATION DEVICE (P100018/S007)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2013-05-09
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