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Neurology

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

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RecordFirmDate
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S243)Medtronic, Inc.2016-02-29
GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES (P140009/S011)ABBOTT MEDICAL2016-02-26
VNS THERAPY ASPIRESR GENERATOR; VNS THERAPY PROGRAMMING SOFTWARE (P970003/S189)LivaNova USA, Inc.2016-02-26
GENESIS,EON,EON C , EON MINI,PROTEGE, BRIO FAMILIES OF DEVICES (P010032/S112)ABBOTT MEDICAL2016-02-26
PULSE/PULSE DUO GENERATOR-MODEL 102/102R (P970003/S188)LivaNova USA, Inc.2016-02-19
EON MINI, PROTEGE, IPG PROTEGE 3.01, IPG PROTEGE MRI (P010032/S111)ABBOTT MEDICAL2016-02-17
ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S002)Nuvectra Corporation2016-02-17
VNS THERAPY SYSTEM (P970003/S170)LivaNova USA, Inc.2016-02-12
Axium Neurostimulator System (P150004)ABBOTT MEDICAL2016-02-11
NOVOCURE'S OPTUNE SYSTEM (P100034/S014)Novocure, GmbH2016-02-09
SPECIFY SURESCAN MRI 5-6-5 LEAD 65 CM, SPECIFY SURESCAN MRI 5-6-5 LEAD 90 CM, SPECIFY SURESCAN MRI 2X8 LEAD 65 CM, SPECI (P840001/S308)Medtronic Neuromodulation2016-02-05
NEUROPACE RNS SYSTEM (P100026/S041)NeuroPace, Inc.2016-02-05
DURASEAL (R) EXACT SPINE SEALANT SYSTEM (P080013/S012)Integra LifeSciences Corporation2016-02-03
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S245)Medtronic, Inc.2016-01-25
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION (P840001/S320)Medtronic Neuromodulation2016-01-25
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S244)Medtronic, Inc.2016-01-22
RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI (P840001/S319)Medtronic Neuromodulation2016-01-22
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S244)Boston Scientific Corp2016-01-15
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME,SPECIFY, & VECTRIS CORD STIMULATION LEADS (P840001/S318)Medtronic Neuromodulation2015-12-23
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S242)Medtronic, Inc.2015-12-23
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S237)Medtronic, Inc.2015-12-21
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION (P840001/S312)Medtronic Neuromodulation2015-12-21
ONYX 18, ONYX LIQUID EMBOLIC SYSTEM, ONYX 34,ONYX LIQUID EMBOLIC SYSTEM, APPOLLO ONYX DELIVERY MICRO CATHETER 1.5CM, STR (P030004/S009)Ev3 Neurovascular2015-12-18
ASPIRESR GENERATOR -MODEL 106 (P970003/S182)LivaNova USA, Inc.2015-12-18
BRIO LE CHARGING SYSTEM (P140009/S005)ABBOTT MEDICAL2015-12-18
EON CHARGING SYSTEM, EON MINI LE CHARGING SYSTEM, PRODIGY CHARGING SYSTEM (P010032/S102)ABBOTT MEDICAL2015-12-18
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S243)Boston Scientific Corp2015-12-18
ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S001)Nuvectra Corporation2015-12-18
BRIO IPG (P140009/S009)ABBOTT MEDICAL2015-12-09
NEUROPACE RNS SYSTEM (P100026/S039)NeuroPace, Inc.2015-12-09
EON MINI (IMPLANTABLE PULSE GENERATOR) IPG, PROTEGE IPG, PROTEGE IPG MRI (P010032/S107)ABBOTT MEDICAL2015-12-09
EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS) (P010032/S106)ABBOTT MEDICAL2015-12-04
BRIO IMPLANTABLE PULSE GENERATORS (IPGS) (P140009/S008)ABBOTT MEDICAL2015-12-04
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION NOVI SPI (P030017/S242)Boston Scientific Corp2015-12-04
RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEAD (P840001/S317)Medtronic Neuromodulation2015-12-03
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S002)Nevro Corporation2015-12-02
VNS THERAPY MODEL 303 LEAD (P970003/S187)LivaNova USA, Inc.2015-11-25
PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S240)Boston Scientific Corp2015-11-24
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S241)Medtronic, Inc.2015-11-20
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY & VECTRIS SPINAL CORD STIMULATION (P840001/S316)Medtronic Neuromodulation2015-11-20
VNS THERAPY PULSE & PULSE DUO GENERATORS,VNS THERAPY DEMIPULSE AND DEMIPULSE DUO GENERATORS,VNS THERAPY ASPIRE HC GENER (P970003/S186)LivaNova USA, Inc.2015-11-20
ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028)Nuvectra Corporation2015-11-20
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S239)Boston Scientific Corp2015-11-18
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S238)Boston Scientific Corp2015-11-18
MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE (P960009/S229)Medtronic, Inc.2015-11-17
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S240)Medtronic, Inc.2015-11-12
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION (SCS) SYSTEMS AND PISCES, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI (P840001/S315)Medtronic Neuromodulation2015-11-12
PRECISION,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S234)Boston Scientific Corp2015-11-12
EON, EONC, EON MINI PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPG'S) (P010032/S105)ABBOTT MEDICAL2015-11-06
BRIO SYSTEMS (P140009/S006)ABBOTT MEDICAL2015-11-06
GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS (P010032/S104)ABBOTT MEDICAL2015-11-06
BRIO IMPLANTABLE PULSE GENERATORS (IPG'S) (P140009/S007)ABBOTT MEDICAL2015-11-06
NEUROPACE RNS SYSTEM (P100026/S038)NeuroPace, Inc.2015-11-05
EXTERNAL PULSE GENERATOR, 2 PORT HEADER (P010032/S103)ABBOTT MEDICAL2015-11-05
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S211)Medtronic, Inc.2015-11-04
GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI) (P010032/S098)ABBOTT MEDICAL2015-11-02
PROCLAIM NEUROSTIMULATION SYSTEM (P010032/S096)ABBOTT MEDICAL2015-11-02
BRIO PATIENT PROGRAMMER (P140009/S002)ABBOTT MEDICAL2015-11-02
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S239)Medtronic, Inc.2015-10-30
RESTORE,ITREL SPINAL CORD STIMULATION SYSTEMS (P840001/S314)Medtronic Neuromodulation2015-10-30
VNS THERAPY SYSTEM, VNS THERAPY PROGRAMMING SOFTWARE (V11.0.4) (P970003/S183)LivaNova USA, Inc.2015-10-28
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S237)Boston Scientific Corp2015-10-22
TRIPOLE, TRIPOLE 16C, TRIPOLE 16, LAMITRODE 4, LAMITRODE 44, LAMITRODE S-4, LAMITRODE S-8, LAMITRODE 88, LAMITRODE WINGE (P010032/S101)ABBOTT MEDICAL2015-10-15
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S238)Medtronic, Inc.2015-10-14
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULA (P840001/S313)Medtronic Neuromodulation2015-10-14
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S236)Boston Scientific Corp2015-10-09
OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM) (P100034/S013)Novocure, GmbH2015-10-05
SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S001)Nevro Corporation2015-10-02
PULSE/PULSE DUO GENERATOR; DEMIPULSE/DEMIPULSE DUO GENERATOR; ASPIREHC GENERATOR; ASPIRESR GENERATOR (P970003/S185)LivaNova USA, Inc.2015-09-30
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM. (P990040/S021)Cerenovus, Inc.2015-09-25
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S091)ABBOTT MEDICAL2015-09-25
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S230)Boston Scientific Corp2015-09-22
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S229)Boston Scientific Corp2015-09-18
SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS (P010032/S099)ABBOTT MEDICAL2015-09-10
SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS (P140009/S003)ABBOTT MEDICAL2015-09-10
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S233)Boston Scientific Corp2015-09-10
NEUROPACE RNS SYSTEM (P100026/S032)NeuroPace, Inc.2015-09-09
RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULATI (P840001/S310)Medtronic Neuromodulation2015-09-04
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S232)Boston Scientific Corp2015-09-02
VNS THERAPY MODEL 302 LEAD (P970003/S184)LivaNova USA, Inc.2015-08-28
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S231)Boston Scientific Corp2015-08-25
PULSE GENERATOR-MODEL102, PULSE DUO GENERATOR-MODEL 102R (P970003/S179)LivaNova USA, Inc.2015-08-21
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEM AND PISCES, RESUME, SPECIFY, AND VECTRIS SPINAL CORD STIMULAT (P840001/S309)Medtronic Neuromodulation2015-08-20
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S236)Medtronic, Inc.2015-08-20
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S235)Medtronic, Inc.2015-08-13
CYBERONICS VNS THERAPY SYSTEM (P970003/S181)LivaNova USA, Inc.2015-07-31
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S217)Boston Scientific Corp2015-07-30
NEUROPACE RNS SYSTEM (P100026/S037)NeuroPace, Inc.2015-07-23
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S306)Medtronic Neuromodulation2015-07-16
RESTORE,ITREL,AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY,AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S307)Medtronic Neuromodulation2015-07-16
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S233)Medtronic, Inc.2015-07-16
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S234)Medtronic, Inc.2015-07-16
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S092)ABBOTT MEDICAL2015-07-09
DEMIPULSE MODEL 103 GENERATOR AND ASPIRESR MODEL 106 GENERATOR (P970003/S180)LivaNova USA, Inc.2015-07-08
ACTIVA PC NEUROSTIMULATOR (P960009/S232)Medtronic, Inc.2015-07-08
RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, RESTOREADVANCED NEUROSTIMULATOR, PRIMEADVANCED SURESCAN MRI (P840001/S305)Medtronic Neuromodulation2015-07-08
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S093)ABBOTT MEDICAL2015-07-06
RESTORE, ITREL, AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATUION LEA (P840001/S304)Medtronic Neuromodulation2015-07-01
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S231)Medtronic, Inc.2015-07-01
NEUROPACE RNS SYSTEM (P100026/S033)NeuroPace, Inc.2015-06-30
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