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Neurology

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

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RecordFirmDate
ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S119)Medtronic, Inc.2011-07-06
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S189)Medtronic Neuromodulation2011-07-06
PIPELINE EMBOLIZATION DEVICE (P100018/S001)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-06-27
ACTIVA SC/SOLETRA/KINETRA (P960009/S118)Medtronic, Inc.2011-06-22
ITREL 3 SYNERGY FAMILY (P840001/S188)Medtronic Neuromodulation2011-06-22
SOLETRA/KINETRA/ACTIVA PC/SC/RC (P960009/S117)Medtronic, Inc.2011-06-17
ITREL 3 IMPLANTABLE PULSE GENERATOR/SYNERGY/SYNERGY VERSITREL/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED (P840001/S187)Medtronic Neuromodulation2011-06-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S120)Boston Scientific Corp2011-06-16
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3 IMPLANTABLE NEUROSTIMULATOR/SYNERGY FAMILY OF IMPLANTABLE NEUROST (P840001/S186)Medtronic Neuromodulation2011-06-16
ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SOLETRA IMPLANTABLE NEUROSTIMULATOR/KINETRA IMPLANTABLE NEUROSTIMULATOR (P960009/S116)Medtronic, Inc.2011-06-16
VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S127)LivaNova USA, Inc.2011-06-03
DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S006)Integra LifeSciences Corporation2011-05-20
VNS THERAPY SYSTEM GENERATORS (P970003/S126)LivaNova USA, Inc.2011-05-20
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S118)Boston Scientific Corp2011-05-09
SYNERGY/SYNERGY VERSITREL IPS/RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCE (P840001/S182)Medtronic Neuromodulation2011-05-06
KINETRA/ACTIVA PC/ACTIVE SC/RC INS (P960009/S112)Medtronic, Inc.2011-05-06
SOLETRA/KINETRA/ACTIVA PC/SC/RC INS (P960009/S114)Medtronic, Inc.2011-05-04
RESTOREPRIME IMPLANTABLE NEUROSTIMULATOR/PRIMEADVANCED/RESTORE/RESTOREULTRA/ITREL 3/SYNERGY/SYNERGY VERSITREL INS (P840001/S183)Medtronic Neuromodulation2011-05-04
VNS THERAPY DEMIPULSE/DEMIPULSE DUO GENERATORS (P970003/S125)LivaNova USA, Inc.2011-04-29
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S113)Medtronic, Inc.2011-04-29
RESTORE FAMILY OF NEUROSTIMULATORS (P840001/S159)Medtronic Neuromodulation2011-04-22
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S090)Medtronic, Inc.2011-04-22
VNS THERAPY SYSTEM (P970003/S124)LivaNova USA, Inc.2011-04-19
NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT (P100034)Novocure, GmbH2011-04-08
PIPELINE EMBOLIZATION DEVICE (P100018)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-04-06
MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR (P960009/S108)Medtronic, Inc.2011-04-04
MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR (P840001/S178)Medtronic Neuromodulation2011-04-04
PRESCISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S117)Boston Scientific Corp2011-03-30
PRESCISION SPINAL CORD STIMULATOR SYSTEM (SCS) (P030017/S116)Boston Scientific Corp2011-03-28
VNS THERAPY SYSTEM (P970003/S123)LivaNova USA, Inc.2011-03-25
ACTIVA SC INS/SOLETRA INS/KINETRA INS/POCKET ADAPTORS (P960009/S111)Medtronic, Inc.2011-03-17
ITREL 3 INS/SYNERGY FAMILY INS/POCKET ADAPTORS (P840001/S181)Medtronic Neuromodulation2011-03-17
MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS (P840001/S102)Medtronic Neuromodulation2011-03-15
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S109)Medtronic, Inc.2011-03-09
ITREL 3/SYNERGY/SYNERGY VERSITREL IPG/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED INS (P840001/S180)Medtronic Neuromodulation2011-03-09
SOLETRA/KINETRA/ACTIVA PC/ACTIVA RC INS (P960009/S110)Medtronic, Inc.2011-03-09
RESTORE IMPLANTABLE NEUROSTIMULATORS (P840001/S179)Medtronic Neuromodulation2011-03-09
VNS THERAPY SYSTEM (P970003/S122)LivaNova USA, Inc.2011-03-02
VNS THERAPY SYSTEM (P970003/S121)LivaNova USA, Inc.2011-02-28
EON WALL CHARGER KIT (P010032/S037)ABBOTT MEDICAL2011-02-24
DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S003)Integra LifeSciences Corporation2011-02-18
VNS THERAPY SYSTEM (P970003/S120)LivaNova USA, Inc.2011-02-17
EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM (P010032/S036)ABBOTT MEDICAL2011-02-11
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S015)Cerenovus, Inc.2011-01-26
ACTIVA SC (P960009/S092)Medtronic, Inc.2011-01-26
EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT (P840001/S176)Medtronic Neuromodulation2011-01-26
EXTERNAL NEUROSTIMULATORS (ENS) FLEX CIRCUIT (P960009/S107)Medtronic, Inc.2011-01-26
VNS THERAPY SYSTEM (P970003/S119)LivaNova USA, Inc.2011-01-21
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S112)Boston Scientific Corp2011-01-20
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S115)Boston Scientific Corp2011-01-20
ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S106)Medtronic, Inc.2011-01-20
DURASEAL DURAL SEALANT SYSTEM (P040034/S019)Integra LifeSciences Corporation2011-01-20
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S114)Boston Scientific Corp2011-01-20
SPINAL CORD STIMULATION SYSTEMS (P840001/S175)Medtronic Neuromodulation2011-01-20
SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S174)Medtronic Neuromodulation2011-01-12
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S113)Boston Scientific Corp2011-01-12
LEAD KIT FOR DEEP BRAIN STIMULATION/QUADRIPOLAR EXTENSION KIT FOR DEEP BRAIN STIMULATION (P960009/S105)Medtronic, Inc.2011-01-07
ITREL 3/SOLETRA/SYNERGY/SYNERGY VERSITREL/OCTAPOLAR EXTENSION KIT (IN-LINE CONNECTOR) FOR NEUROSTIMULATION (P840001/S173)Medtronic Neuromodulation2011-01-07
ACTIVA FAMILY/SOLETRA/KINETRA IMPLANTABLE NEUROSTIMULATORS/LEADS/STEREOTACTIC FRAME LEAD KIT/EXTENSIONS/ADAPTORS/MAGNET (P960009/S104)Medtronic, Inc.2011-01-05
RESTORE FAMILY/ITREL3 FAMILY/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SPECIFY SURGICAL LEADS/HINGED 2X4 SURGICAL (P840001/S172)Medtronic Neuromodulation2011-01-05
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S105)Boston Scientific Corp2010-12-29
ACTIVA SC INS/SOLETRA INS/KINETRA INS (P960009/S102)Medtronic, Inc.2010-12-23
SPINAL CORD STIMULATION SYSTEMS (P840001/S171)Medtronic Neuromodulation2010-12-23
ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S103)Medtronic, Inc.2010-12-23
ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS (P840001/S170)Medtronic Neuromodulation2010-12-23
ACTIVA SC/SOLETRA/KINETRA INS (P960009/S101)Medtronic, Inc.2010-12-22
TRUFILL N-BUTYLCYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S016)Cerenovus, Inc.2010-12-22
ITREL 3 INS/SYNERGY FAMILY INS/EXTENSION KIT, RESTORE/POCKET ADAPTORS (P840001/S169)Medtronic Neuromodulation2010-12-22
VNS THERAPY SYSTEMS (P970003/S118)LivaNova USA, Inc.2010-12-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S111)Boston Scientific Corp2010-12-17
SOLETRA/KINETRA/EXTERNAL/ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S100)Medtronic, Inc.2010-11-24
ITREL 3 IMPLANTABLE/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/EXTERNAL NEUROSTIMULATORS (P840001/S168)Medtronic Neuromodulation2010-11-24
OLYMPIC COOL-CAP SYSTEM (P040025/S011)Natus Medical Incorporated2010-11-23
VNS THERAPY SYSTEM MODEL 250 PROGRAMMING SOFTWARE, VERSION 8.0 (P970003/S116)LivaNova USA, Inc.2010-11-23
IMPLANTABLE PULSE GENERATOR SYSTEM (P010032/S034)ABBOTT MEDICAL2010-11-19
VNS THERAPY SYSTEM (P970003/S115)LivaNova USA, Inc.2010-11-18
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S110)Boston Scientific Corp2010-11-17
PADDLE LEAD KITS DFU (P010032/S035)ABBOTT MEDICAL2010-11-17
ACTIVA RC & SOLETRA IMPLANTABLE NEUROSTIMULATORS (P960009/S099)Medtronic, Inc.2010-11-10
ITREL 3 & RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S167)Medtronic Neuromodulation2010-11-10
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S014)Cerenovus, Inc.2010-11-10
VNS THERAPY SYSTEM PULSE GENERATOR CLEANING PROCESS CHANGE (P970003/S110)LivaNova USA, Inc.2010-11-05
SPINAL CORD STIMULATION SYSTEMS (P840001/S158)Medtronic Neuromodulation2010-11-01
ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY (P960009/S089)Medtronic, Inc.2010-11-01
ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P960009/S097)Medtronic, Inc.2010-10-14
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S165)Medtronic Neuromodulation2010-10-14
VNS THERAPY SYSTEM (P970003/S114)LivaNova USA, Inc.2010-10-13
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S108)Boston Scientific Corp2010-10-08
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S013)Cerenovus, Inc.2010-10-08
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S109)Boston Scientific Corp2010-10-08
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S096)Medtronic, Inc.2010-10-01
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (INS) (P840001/S164)Medtronic Neuromodulation2010-10-01
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S012)Cerenovus, Inc.2010-09-27
VNS THERAPY PROGRAMMING SOFTWARE (P970003/S112)LivaNova USA, Inc.2010-09-17
RESTORE ULTRA IMPLANTABLE NEUROSTIMULATOR (P840001/S163)Medtronic Neuromodulation2010-09-16
DURASEAL DURAL SEALANT SYSTEM (P040034/S017)Integra LifeSciences Corporation2010-09-16
ACTIVA RC DEEP BRAIN STIMULATOR (P960009/S095)Medtronic, Inc.2010-09-16
ACCESS THERAPY CONTROLLER & ACCESS THERAPY CONTROLLER (P960009/S094)Medtronic, Inc.2010-09-10
ITREL & SYNERGY EZ PATIENT PROGRAMMER (P840001/S162)Medtronic Neuromodulation2010-09-10
RESTORE ULTRA (P840001/S161)Medtronic Neuromodulation2010-09-10
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