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Neurology

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

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RecordFirmDate
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S156)Boston Scientific Corp2013-05-08
GENESIS, GENESISRC AND GENESIS XP NEUROSTIMULATION SYSTEMS (P010032/S061)ABBOTT MEDICAL2013-05-08
VNS THERAPY SYSTEM LEADS (P970003/S161)LivaNova USA, Inc.2013-05-03
VNS THERAPY ACCESSORY PACK (P970003/S158)LivaNova USA, Inc.2013-05-02
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S161)Boston Scientific Corp2013-05-01
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S162)Boston Scientific Corp2013-04-30
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S159)Boston Scientific Corp2013-04-17
ACTIVA PC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA SC NEUROSTIMULATOR, ACTIVA RC NEUROSTIMULATOR (P960009/S168)Medtronic, Inc.2013-04-17
RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD (P840001/S237)Medtronic Neuromodulation2013-04-17
NOVOTTF-100A SYSTEM (P100034/S003)Novocure, GmbH2013-04-17
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S158)Boston Scientific Corp2013-04-16
VNS THERAPY SYSTEM (P970003/S160)LivaNova USA, Inc.2013-04-12
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S160)Boston Scientific Corp2013-04-12
EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688 (P010032/S063)ABBOTT MEDICAL2013-04-11
GENESIS NEUROSTIMULATION SYSTEMS (P010032/S070)ABBOTT MEDICAL2013-04-10
PERENNIADURA MODEL 303 LEAD (P970003/S157)LivaNova USA, Inc.2013-04-03
PULSE AND PULSE DUO GENERATORS, DEMIPULSE AND DEMIPULSE DUO GENERATORS, ASPIREHC MODEL 105 GENERATOR (P970003/S159)LivaNova USA, Inc.2013-04-03
PIPLINE TM EMBOLIZATION DEVICE (P100018/S006)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2013-04-02
SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S219)Medtronic Neuromodulation2013-03-20
EON MINI IMPLANTABLE PULSE GENERATOR (P010032/S066)ABBOTT MEDICAL2013-03-15
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S155)Boston Scientific Corp2013-03-15
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S154)Boston Scientific Corp2013-03-08
PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S153)Boston Scientific Corp2013-02-26
VNS THERAPY PULSE/PULSE DUO GENERATOR (P970003/S155)LivaNova USA, Inc.2013-02-25
DBS NEUROSTIMULATORS EXTERNAL, DBS NEUROSTIMULATORS IMPLANTABLE ACTIVA FAMILY (P960009/S164)Medtronic, Inc.2013-02-25
SCS NEUROSTIMULATORS EXTERNAL, SCS NEUROSTIMULATORS IMPLANTABLE ITREL FAMILY, SCS NEUROSTIMULATORS IMPLANTABLE RESTORE (P840001/S233)Medtronic Neuromodulation2013-02-25
ACTIVA SC NEUROSTIMULATOR, SOLETRA NEUROSTIMULATOR, KINETRA NEUROSTIMULATOR (P960009/S162)Medtronic, Inc.2013-02-14
ITREL 4 NEUROSTIMULATOR, ITREL 3 NEUROSTIMULATOR, SYNERGY NEUROSTIMULATOR, SYNERGY VERSITREL NEUROSTIMULATOR (P840001/S232)Medtronic Neuromodulation2013-02-14
VNS THERAPY PULSE GENERATOR (DEMIPULSE AND DEMIPULSE DUO) (P970003/S156)LivaNova USA, Inc.2013-02-07
VNS THERAPY SYSTEM (P970003/S154)LivaNova USA, Inc.2013-02-01
PIPELINE EMBOLIZATION DEVICE (P100018/S005)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2013-01-18
PRECISION SOINAL CORD STIMULATOR SYSTEM (P030017/S151)Boston Scientific Corp2013-01-16
EON MINI LE CHARGER, EON MINI LE CHARGING SYSTEM (P010032/S065)ABBOTT MEDICAL2013-01-16
EON NEUROSTIMULATION SYSTEM (P010032/S059)ABBOTT MEDICAL2013-01-09
SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS (P840001/S231)Medtronic Neuromodulation2013-01-08
DBS ACCESSORIES,DBS EXTENSIONS,DBS LEADS,DBS NEUROSTIMULATORS IMPLANTABLE,DBS NEUROSTIMULATORS SOLETRA FAMILY (P960009/S161)Medtronic, Inc.2013-01-08
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S147)Boston Scientific Corp2013-01-03
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S146)Boston Scientific Corp2012-12-28
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S134)Boston Scientific Corp2012-12-21
ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA, SOLETRA (P960009/S160)Medtronic, Inc.2012-12-17
ITREL 3, ITREL 4, SYNERGY, SYNERGY VERSITREL, RESTORE, RESTOREPRIME, ADVANCEDRESTORE, ULTRA, ENS (P840001/S230)Medtronic Neuromodulation2012-12-17
EON 16-CHANNEL IPG NEUROSTIMULATION SYSTEM, EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S064)ABBOTT MEDICAL2012-12-04
NOVOTTF-100A SYSTEM (P100034/S002)Novocure, GmbH2012-12-03
SPINAL CORD STIMULATION - IMPLANTABLE NEUROSTIMULATORS (P840001/S223)Medtronic Neuromodulation2012-12-03
DBS IMPLANTABLE NEUROSTIMULATORS (P960009/S152)Medtronic, Inc.2012-12-03
PRECISON SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S145)Boston Scientific Corp2012-11-19
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S144)Boston Scientific Corp2012-11-16
ACTIVA SC, 37602 AND 37603 (P960009/S159)Medtronic, Inc.2012-11-02
INTREL 4, 37703 AND 37704 (P840001/S229)Medtronic Neuromodulation2012-11-02
VNS THERAPY SYSTEM (P970003/S153)LivaNova USA, Inc.2012-10-30
EON NEUROSTIMULATION SYSTEM (P010032/S055)ABBOTT MEDICAL2012-10-25
ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL 4 (P840001/S228)Medtronic Neuromodulation2012-10-24
SOLETRA, KINETRA, ACTIVA SC (P960009/S158)Medtronic, Inc.2012-10-24
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S143)Boston Scientific Corp2012-10-11
ACTIVA PC, ACTIVA SC, ACTIVA RC IMPLANTABLE NEUROSTIMULATORS (P960009/S157)Medtronic, Inc.2012-10-10
EXTERNAL NEUROSTIMULATOR,ITREL4,ITREL4X,RESTORE PRIME,PRIMEADVANCED,RESTORE,RESTORE ULTRA,RESTORE ADVANCED & SENSOR (P840001/S227)Medtronic Neuromodulation2012-10-10
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S140)Boston Scientific Corp2012-10-01
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S142)Boston Scientific Corp2012-09-26
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S141)Boston Scientific Corp2012-09-14
SPINAL CORD STIMULATION EXTENSION MODELS 37081, 37082 AND 37083 (P840001/S221)Medtronic Neuromodulation2012-09-14
EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S058)ABBOTT MEDICAL2012-09-14
SOLETRA, KINETRA, ACTIVA (P960009/S155)Medtronic, Inc.2012-09-13
ITREL, SYNERGEY, RESTOR (P840001/S226)Medtronic Neuromodulation2012-09-13
VNS THERAPY PULSE GENERATOR, 102/102R (P970003/S152)LivaNova USA, Inc.2012-09-13
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S154)Medtronic, Inc.2012-09-12
RESTORE RECHARGEABLE,RESTORE PRIME,RESTORE,ADVANCED,PRIME ADVANCED,RESTORE ULTRA,ITREL 4,SYNERGY,SYNERGY VERSTIREL (P840001/S225)Medtronic Neuromodulation2012-09-12
VNS THERAPY SYSTEM (P970003/S151)LivaNova USA, Inc.2012-09-06
INJEX MODEL 97791 BUMPY & MODEL 97792 BI-WING ANCHOR KITS (P840001/S199)Medtronic Neuromodulation2012-09-06
PENTA LEAD SERIES (P010032/S062)ABBOTT MEDICAL2012-08-31
EON IMPLANTABLE PULSE GENERATOR (P010032/S057)ABBOTT MEDICAL2012-08-24
ACTIVA IMPLAMTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC M (P960009/S149)Medtronic, Inc.2012-08-24
ITREL 3, SYNERGY, SYNERGY VERSITREL, ITREL, POCKET ADAPTOR (P840001/S224)Medtronic Neuromodulation2012-08-22
SOLETRA, KINETRA, ACTIVA SC, POCKET ADAPTOR (P960009/S153)Medtronic, Inc.2012-08-22
PRECIOUS SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S139)Boston Scientific Corp2012-08-15
EON, EONC AND EON MINI NEUROSTIMULATION SYSTEMS (P010032/S060)ABBOTT MEDICAL2012-08-10
ACTIVA RC IMPLANTABLE NEUROSTIMULATOR (P960009/S151)Medtronic, Inc.2012-08-10
ITREL 3 AND 4, SYNERGY, SYNERGY VERSITREL SPINAL CORD STIMULATION SYSTEM;RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM (P840001/S220)Medtronic Neuromodulation2012-08-10
ACTIVA RC IMPLANTABLE NEUROSTIMULAOR 37612 (P960009/S150)Medtronic, Inc.2012-08-01
RESTORESENSOR, 37714 (P840001/S222)Medtronic Neuromodulation2012-08-01
RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR 37712, RESTORESENSOR IMPLANTABLE NEUROSTIMULATOR 37714 (P840001/S218)Medtronic Neuromodulation2012-08-01
CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA (P010032/S056)ABBOTT MEDICAL2012-08-01
RAPID PROGRAMMER (P010032/S053)ABBOTT MEDICAL2012-07-31
VNS THERAPY SYSTEM (P970003/S150)LivaNova USA, Inc.2012-07-26
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S138)Boston Scientific Corp2012-07-24
VNS THERAPY SYSTEM (P970003/S148)LivaNova USA, Inc.2012-07-23
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S137)Boston Scientific Corp2012-07-17
ANTENNA AND PORTABLE CHARGER (P010032/S054)ABBOTT MEDICAL2012-07-12
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S136)Boston Scientific Corp2012-07-10
AXXESS PERCUTANEOUS LEAD (P010032/S052)ABBOTT MEDICAL2012-06-22
VNS THERAPY SYSTEM (P970003/S149)LivaNova USA, Inc.2012-06-20
SCS INS ITREL FAMILY, SCS INS SYNERGY FAMILY (P840001/S217)Medtronic Neuromodulation2012-06-15
DBS INS SOLETRA FAMILY, DBS INS KINETRA FAMILY (P960009/S148)Medtronic, Inc.2012-06-15
RESTORE, ITREL, SYNERGY (P840001/S215)Medtronic Neuromodulation2012-06-08
ACTIVA, SOLETRA, KINETRA (P960009/S146)Medtronic, Inc.2012-06-08
DBS IMPLANTABLE NEUROSTIMULATORS (P960009/S147)Medtronic, Inc.2012-06-07
SCS IMPLANTABLE NEUROSTIMULATORS (P840001/S216)Medtronic Neuromodulation2012-06-07
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S135)Boston Scientific Corp2012-06-06
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S145)Medtronic, Inc.2012-06-05
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S214)Medtronic Neuromodulation2012-06-05
MODEL 74001 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION;MODEL 74002 2X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION (P840001/S213)Medtronic Neuromodulation2012-05-30
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