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Neurology

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

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RecordFirmDate
ACTIVA FAMILY OF IMPLANTABLE DEEP BRAIN IMPLANTABLE NEUROSTIMULATORS (P960009/S207)Medtronic, Inc.2014-10-16
RESTORE FAMILY OF IMPLANTABLE SCS NEUROSTIMULATORS (P840001/S285)Medtronic Neuromodulation2014-10-16
ST. JUDE MEDICAL ADAPTER (P010032/S083)ABBOTT MEDICAL2014-10-15
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S204)Boston Scientific Corp2014-10-09
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S205)Boston Scientific Corp2014-10-09
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION (P840001/S282)Medtronic Neuromodulation2014-10-08
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S205)Medtronic, Inc.2014-10-08
TRIPOLE 16 & 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44 & LAMITRODE 44C LEADS, LAMITRODE 88 LEAD, LAMITRODE S-4 (P010032/S084)ABBOTT MEDICAL2014-10-06
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD (P840001/S283)Medtronic Neuromodulation2014-10-03
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S206)Medtronic, Inc.2014-10-03
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S203)Boston Scientific Corp2014-10-02
OPTUNE (P100034/S010)Novocure, GmbH2014-09-28
GENESIS IPG, EON IPG, EON C IPG, EON MINI IPG, PROTEGE IPG (P010032/S081)ABBOTT MEDICAL2014-09-16
DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S204)Medtronic, Inc.2014-09-15
SCS NEUROSTIMULATORS IMPLANTABLE RESTORE FAMILY (P840001/S281)Medtronic Neuromodulation2014-09-15
NEUROPACE RNS SYSTEM (P100026/S022)NeuroPace, Inc.2014-09-05
NEUROPACE RNS SYSTEM (P100026/S021)NeuroPace, Inc.2014-09-03
NEUROPACE RNS SYSTEM (P100026/S020)NeuroPace, Inc.2014-09-02
ACTIVA IMPLANTABLE NEUROSTIMULATIORS (P960009/S201)Medtronic, Inc.2014-08-29
PRECISION SPECTRA SYSTEM (P030017/S201)Boston Scientific Corp2014-08-28
ACTIVA SC, ACTIVA SC, KINETRA, SOLETRA (P960009/S200)Medtronic, Inc.2014-08-27
RESTORE, PRIME ADVANCED, ITREL, AND SYNERGY FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S280)Medtronic Neuromodulation2014-08-27
ACTIVA FAMILY FOR DEEP BRAIN STIMULATION -TREMOR CONTROL (P960009/S202)Medtronic, Inc.2014-08-27
ITREL 4, ITREL 4, ITREL 3, SYNERGY, SYNERGY VERSITREL (P840001/S279)Medtronic Neuromodulation2014-08-27
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S152)Boston Scientific Corp2014-08-26
NEUROPACE RNS SYSTEM (P100026/S024)NeuroPace, Inc.2014-08-22
NEUROPACE RNS SYSTEM (P100026/S023)NeuroPace, Inc.2014-08-21
PIPELINE EMBOLIZATION DEVICE (P100018/S012)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-08-20
INJEX ANCHOR KITS AND VECTRIS SURESCAN MRI LEAD KITS (P840001/S278)Medtronic Neuromodulation2014-08-19
ITREL TOTALLY IMPLANTABLE SPINAL CORD STIMULATOR SYSTEM (P840001/S277)Medtronic Neuromodulation2014-08-08
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S198)Boston Scientific Corp2014-08-06
RESTOREULTRA RECHARGEABLE NEUROSTIMULATOR, RESTOREADVANCED RECHARGEABLE NEUROSTIMULATOR, RESTOREULTRA SURESCAN MRI (P840001/S275)Medtronic Neuromodulation2014-08-01
ACTIVA (P960009/S199)Medtronic, Inc.2014-08-01
ACTIVA RC RECHARGEABLE NEUROSTIMULATOR (P960009/S198)Medtronic, Inc.2014-08-01
RESTORE (P840001/S276)Medtronic Neuromodulation2014-08-01
NOVOTTF-100A TREATMENT KIT (P100034/S009)Novocure, GmbH2014-07-25
NOVO TTF-100A SYSTEM (P100034/S008)Novocure, GmbH2014-07-24
SCS NEUROSTIMULATORS IMPLATABLE RESTORE FAMILY (P840001/S274)Medtronic Neuromodulation2014-07-22
VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304 (P970003/S172)LivaNova USA, Inc.2014-07-17
VECTRIS SURESCAN MRI LEADS 1X8 SUBCOMPACT & COMBACT, VECTRIS TRIAL SCREENING LEAD 1X8 SUBCOMPACT & COMPACT (P840001/S272)Medtronic Neuromodulation2014-07-17
EON, EON MINI AND PROTEGE IPG'S (P010032/S082)ABBOTT MEDICAL2014-07-17
PROTEGE NEUROSTIMULATION SYSTEM (P010032/S079)ABBOTT MEDICAL2014-07-14
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S200)Boston Scientific Corp2014-07-11
NEUROPACE RNS SYSTEM (P100026/S017)NeuroPace, Inc.2014-07-09
NEUROPACE RNS SYSTEM (P100026/S019)NeuroPace, Inc.2014-07-09
EON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE (P010032/S078)ABBOTT MEDICAL2014-07-07
ITREL,RESTORE, SYNERGY SYSTEMS (P840001/S271)Medtronic Neuromodulation2014-07-03
ACTIVA,KINETRA,SOLETRA SYSTEMS (P960009/S196)Medtronic, Inc.2014-07-03
EON CHARGING SYSTEM (P010032/S075)ABBOTT MEDICAL2014-07-02
VNS THERAPY GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC) (P970003/S169)LivaNova USA, Inc.2014-07-02
RESTORESENSOR RECHARGEABLE NEUROSTIMULATOR; RESTORESENSOR SURESCAN MRI RECHARGEABLE NEUROSTIMULATOR (P840001/S270)Medtronic Neuromodulation2014-07-02
SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY (P840001/S269)Medtronic Neuromodulation2014-06-27
DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S195)Medtronic, Inc.2014-06-27
OCTRODE LEADS (P010032/S080)ABBOTT MEDICAL2014-06-27
NEUROPACE RNS SYSTEM (P100026/S018)NeuroPace, Inc.2014-06-18
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S191)Boston Scientific Corp2014-06-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S199)Boston Scientific Corp2014-06-06
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S197)Boston Scientific Corp2014-06-06
SCS NEUROSTIMULATORS IMPLANTABLE ITREL, RESORE AND SYNERGY FAMILIES, (P840001/S260)Medtronic Neuromodulation2014-06-04
DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA, KINETRA AND SOLETRA FAMILIES (P960009/S188)Medtronic, Inc.2014-06-04
PRECISION SPECTRA SYSTEM (P030017/S196)Boston Scientific Corp2014-06-04
ONYX LIQUID EMBOLIC SYSTEM (P030004/S006)Ev3 Neurovascular2014-05-27
DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S194)Medtronic, Inc.2014-05-23
SCS NEUROSTIMULATORS IMPLAMTABLE RESTORE FAMILY (P840001/S268)Medtronic Neuromodulation2014-05-23
PRECISION SPECTRA SPINAL STIMULATOR (SCS) SYSTEM (P030017/S186)Boston Scientific Corp2014-05-22
VNS THERAPY SYSTEM (P970003/S166)LivaNova USA, Inc.2014-05-09
NEUROPACE RNS SYSTEM (P100026/S011)NeuroPace, Inc.2014-05-07
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S194)Boston Scientific Corp2014-05-02
PRECISSION SPINAL CORD SIMULATOR (SCS) SYSTEM (P030017/S195)Boston Scientific Corp2014-05-02
NEUROPACE RNS SYSTEM (P100026/S016)NeuroPace, Inc.2014-05-01
NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS) (P840001/S267)Medtronic Neuromodulation2014-04-30
NEUROSTIMULATION SYSTEM FOR DEEP BRAIN STIMULATION (DBS) (P960009/S193)Medtronic, Inc.2014-04-30
EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S073)ABBOTT MEDICAL2014-04-25
EON CTM IPG NEUROSTIMULATION SYSTEM (P010032/S076)ABBOTT MEDICAL2014-04-25
ITREL/ RESTORE/ SYNERGY/ SCS IMPLANTABLE NEUROSTIMULATOR SYSTEM FAMILIES (P840001/S266)Medtronic Neuromodulation2014-04-24
ACTIVA/ KINETRA/ SOLETRA IMPLANTABLE DEEP BRAIN STIMULATION SYSTEM FAMILIES (P960009/S192)Medtronic, Inc.2014-04-24
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S193)Boston Scientific Corp2014-04-21
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S192)Boston Scientific Corp2014-04-17
NEUROPACE RNS SYSTEM (P100026/S015)NeuroPace, Inc.2014-04-14
SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY (P840001/S265)Medtronic Neuromodulation2014-04-10
ACTIVA PC IMPLANTABLE NEUROSTIMULATOR (P960009/S191)Medtronic, Inc.2014-04-10
SURESCAN MRI IMPLANTABLE NEUROSTIMULATORS (P840001/S264)Medtronic Neuromodulation2014-04-09
DBS EXTENSIONS (P960009/S190)Medtronic, Inc.2014-04-04
NEUROPACE RNS SYSTEM (P100026/S014)NeuroPace, Inc.2014-04-04
TRIPOLE 16 AND TRIPOLE 16C LEADS, EXCLAIM LEADS, LAMITRODE 4, LAMITRODE 44, LAMITRODE 44C LEADS, LAMITRODE 88 LEAD (P010032/S077)ABBOTT MEDICAL2014-04-04
SCS EXTENSIONS, HINGED 2X4 SURGICAL LEAD, SPECIFY LEAD (P840001/S263)Medtronic Neuromodulation2014-04-04
CYBERONICS VNS THERAPY SYSTEM (P970003/S168)LivaNova USA, Inc.2014-03-28
PROTEGE SYSTEM (P010032/S074)ABBOTT MEDICAL2014-03-21
NEUROPACE RNS SYSTEM (P100026/S013)NeuroPace, Inc.2014-03-21
RESTOREPRIME NEUROSTIMULATOR,PRIMEADVANCED NEUROSTIMULATOR,ITREL 4 NEUROSTIMULATOR,PRIMEADVANCED SURESCAN MRI NEUROSTIMU (P840001/S262)Medtronic Neuromodulation2014-03-19
ACTIVA PC NEUROSTIMULATOR,ACTIVA SCNEUROSTIMULATOR,ACTIVA SC NEUROSTIMULATOR (P960009/S189)Medtronic, Inc.2014-03-19
MEDTRONIC SPINAL CORD STIMULATION SYSTEMS (P840001/S261)Medtronic Neuromodulation2014-03-13
DURASEAL DURAL SEALANT SYSTEM (P040034/S023)Integra LifeSciences Corporation2014-03-11
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEMS (P030017/S190)Boston Scientific Corp2014-03-07
PRECISION SPECTRA SYSTEM (P030017/S185)Boston Scientific Corp2014-03-07
PIPELINE EMBOLIZATION DEVICE (P100018/S010)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-02-27
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S189)Boston Scientific Corp2014-02-25
NEUROPACE RNS SYSTEM (P100026/S010)NeuroPace, Inc.2014-02-25
NEUROPACE RNS SYSTEM (P100026/S004)NeuroPace, Inc.2014-02-24
NEUROPACE RNS SYSTEM (P100026/S009)NeuroPace, Inc.2014-02-21
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