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Neurology

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

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RecordFirmDate
NEUROPACE RNS SYSTEM (P100026/S034)NeuroPace, Inc.2015-06-30
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S230)Medtronic, Inc.2015-06-26
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S228)Boston Scientific Corp2015-06-26
RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S303)Medtronic Neuromodulation2015-06-26
IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM (P960009/S169)Medtronic, Inc.2015-06-22
BRIO NEUROSTIMULATION SYSTEM (P140009)ABBOTT MEDICAL2015-06-12
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S227)Boston Scientific Corp2015-06-11
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S228)Medtronic, Inc.2015-06-11
RESTORE, ITREL, & SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S302)Medtronic Neuromodulation2015-06-11
RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATIONS LEA (P840001/S301)Medtronic Neuromodulation2015-06-08
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S227)Medtronic, Inc.2015-06-08
NEUROPACE RNS SYSTEM (P100026/S035)NeuroPace, Inc.2015-06-05
VNS THERAPY SYSTEM (P970003/S174)LivaNova USA, Inc.2015-06-04
VNS THERAPY ASPIRESR (P970003/S173)LivaNova USA, Inc.2015-05-29
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S226)Boston Scientific Corp2015-05-29
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEMS (P030017/S216)Boston Scientific Corp2015-05-27
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S226)Medtronic, Inc.2015-05-18
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S225)Medtronic, Inc.2015-05-18
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT (P840001/S300)Medtronic Neuromodulation2015-05-18
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S220)Medtronic, Inc.2015-05-11
PRECISION SPECTRA TM SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S223)Boston Scientific Corp2015-05-11
DURASEAL EXACT SPINE SEALANT (P080013/S011)Integra LifeSciences Corporation2015-05-11
NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022)Nevro Corporation2015-05-08
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S224)Boston Scientific Corp2015-05-07
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S222)Boston Scientific Corp2015-05-04
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S221)Boston Scientific Corp2015-04-29
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S213)Boston Scientific Corp2015-04-28
PROTEGE MRI NEUROSTIMULATION SYSTEM (P010032/S085)ABBOTT MEDICAL2015-04-22
DEMIPULSE MODEL 103 GENERATOR (P970003/S178)LivaNova USA, Inc.2015-04-22
RESTORE,ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY, VECTRIS SPINAL CORD STIMULAION LEADS (P840001/S299)Medtronic Neuromodulation2015-04-22
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S224)Medtronic, Inc.2015-04-17
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCE, SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S298)Medtronic Neuromodulation2015-04-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S220)Boston Scientific Corp2015-04-14
VNS THERAPY SYSTEM PROGRAMMING SOFTWARE (P970003/S177)LivaNova USA, Inc.2015-04-10
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S218)Boston Scientific Corp2015-04-10
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S219)Boston Scientific Corp2015-04-10
NEUROPACE RNS SYSTEM (P100026/S028)NeuroPace, Inc.2015-04-08
NEUROPACE RNS SYSTEM (P100026/S031)NeuroPace, Inc.2015-04-08
RESTORE AND ITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S297)Medtronic Neuromodulation2015-04-08
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S223)Medtronic, Inc.2015-04-08
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S296)Medtronic Neuromodulation2015-04-02
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S222)Medtronic, Inc.2015-04-02
PRECISION SPECTRA SPINAL CORD STUMULATOR (SCS) SYSTEM (P030017/S206)Boston Scientific Corp2015-03-31
ADHERUS AUTOSPRAY DURAL SEALANT (P130014)Stryker Leibinger GmbH & Co KG2015-03-30
RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S295)Medtronic Neuromodulation2015-03-27
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S221)Medtronic, Inc.2015-03-27
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S215)Boston Scientific Corp2015-03-25
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S094)ABBOTT MEDICAL2015-03-24
TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S020)Cerenovus, Inc.2015-03-24
NOVOTTF-100A SYSTEM (P100034/S012)Novocure, GmbH2015-03-23
RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S294)Medtronic Neuromodulation2015-03-20
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S218)Medtronic, Inc.2015-03-20
NOVA TTF-100A SYSTEM (P100034/S011)Novocure, GmbH2015-03-17
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S214)Boston Scientific Corp2015-03-13
NEUROPACE RNS SYSTEM (P100026/S026)NeuroPace, Inc.2015-03-10
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S293)Medtronic Neuromodulation2015-03-06
NEUROPACE RNS SYSTEM (P100026/S030)NeuroPace, Inc.2015-03-06
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S217)Medtronic, Inc.2015-03-06
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S090)ABBOTT MEDICAL2015-03-04
PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105 (P970003/S176)LivaNova USA, Inc.2015-03-04
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S095)ABBOTT MEDICAL2015-02-27
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S212)Boston Scientific Corp2015-02-25
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA (P840001/S292)Medtronic Neuromodulation2015-02-20
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S216)Medtronic, Inc.2015-02-20
NEUROPACE RNS SYSTEM (P100026/S029)NeuroPace, Inc.2015-02-19
RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEMS (P840001/S291)Medtronic Neuromodulation2015-02-19
PRECISION SPINAL CORD STIMULATOR(SCS) SYSTEM AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S210)Boston Scientific Corp2015-02-13
PRECISION SPECTRA SYSTEM (P030017/S209)Boston Scientific Corp2015-02-12
ST. JUDE MEDICAL ADAPTER (P010032/S087)ABBOTT MEDICAL2015-02-12
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S215)Medtronic, Inc.2015-02-11
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S290)Medtronic Neuromodulation2015-02-11
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S214)Medtronic, Inc.2015-02-10
RESTORE,ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S289)Medtronic Neuromodulation2015-02-10
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEA (P840001/S288)Medtronic Neuromodulation2015-02-06
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S213)Medtronic, Inc.2015-02-06
PIPELINE EMBOLIZATION DEVICES,PIPELINE FLEX EMBOLIZATION DEVICE (P100018/S011)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2015-01-26
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S211)Boston Scientific Corp2015-01-21
NEUROPACE RNS SYSTEM (P100026/S027)NeuroPace, Inc.2015-01-16
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S287)Medtronic Neuromodulation2015-01-16
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S212)Medtronic, Inc.2014-12-22
NEUROPACE RNS SYSTEM (P100026/S025)NeuroPace, Inc.2014-12-22
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S286)Medtronic Neuromodulation2014-12-22
EON TM, EONC TM, PROTEGE, PROTEGE MRI AND BRIO IMPLANTABLE PULSE GENERATOR (P010032/S088)ABBOTT MEDICAL2014-12-19
PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S202)Boston Scientific Corp2014-12-19
TRIPOLE 16/16C,EXCLAIM,LAMITRODE 4/44/44C/88/S-4/S8, PENTA,OCTRODE, AND QUATTRODE LEADS (P010032/S089)ABBOTT MEDICAL2014-12-18
VNS THERAPY DEMIPULSE AND VNS THERAPY DEMIPULSE DUO (P970003/S175)LivaNova USA, Inc.2014-12-17
DURASEAL DURAL SEALANT SYSTEM (P040034/S024)Integra LifeSciences Corporation2014-12-11
ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS (P840001/S273)Medtronic Neuromodulation2014-12-05
ACTIVA DEEP BRAIN STIMULATION SYSTEM (P960009/S197)Medtronic, Inc.2014-12-05
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S208)Boston Scientific Corp2014-11-26
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S210)Medtronic, Inc.2014-11-21
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S207)Boston Scientific Corp2014-11-14
EON MINI, PROTEGE AND PROTEGE MRI IPGS (3788. 3789, & 3771) (P010032/S086)ABBOTT MEDICAL2014-11-13
NOVOTFF-100A SYSTEM (P100034/S007)Novocure, GmbH2014-11-12
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S019)Cerenovus, Inc.2014-11-05
PIPELINE EMBOLIZATION DEVICE (P100018/S013)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-11-04
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S203)Medtronic, Inc.2014-10-24
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S209)Medtronic, Inc.2014-10-17
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S208)Medtronic, Inc.2014-10-16
RESTORE, ITREL, SYNERGY SPINAL CORD STIMULATION SYSTEM, PISCES, SPECIFY AND VECTRIS, SPINAL CORD STIMULATION LEADS (P840001/S284)Medtronic Neuromodulation2014-10-16
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