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Neurology

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

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RecordFirmDate
MODEL 640011X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION;MODEL 64002 2X4 POCKET ADAPTOR FOR DEEP BRAIN STIMULATION (P960009/S144)Medtronic, Inc.2012-05-30
ITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S211)Medtronic Neuromodulation2012-05-30
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S133)Boston Scientific Corp2012-05-24
MEDTRONIC RESTORESENSOR NEUROSTIMULATOR (P840001/S208)Medtronic Neuromodulation2012-05-24
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S051)ABBOTT MEDICAL2012-05-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S132)Boston Scientific Corp2012-05-10
DEEP BRAIN STIMULATION (DBS) INS ACTIVA FAMILY, DBS ACCESSORIES, DBS INS SOLETRA FAMILY & DBS INS KINETRA FAMILY (P960009/S143)Medtronic, Inc.2012-05-10
SPINAL CORD STIMULATION (SCS) INPLANTABLE NEUROSTIMULATORS (INS) RESTORE FAMILY (P840001/S212)Medtronic Neuromodulation2012-05-10
MODEL 3587A RESUME II AND 3986A RESUME TL LEADS (P840001/S209)Medtronic Neuromodulation2012-05-02
ACTIVA SC MODEL 37603 IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR REWORK (P960009/S141)Medtronic, Inc.2012-05-02
IMPLANTABLE PULSE GENERATORS (P010032/S049)ABBOTT MEDICAL2012-04-25
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S207)Medtronic Neuromodulation2012-04-25
ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S139)Medtronic, Inc.2012-04-25
ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATOR (P960009/S138)Medtronic, Inc.2012-04-20
37751 RECHARGE CHARGING SYSTEM (P960009/S142)Medtronic, Inc.2012-04-20
37751 RECHARGE CHARGING SYSTEM (P840001/S210)Medtronic Neuromodulation2012-04-20
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S206)Medtronic Neuromodulation2012-04-20
VNS THERAPY SYSTEM GENERATORS (P970003/S147)LivaNova USA, Inc.2012-04-13
1X4 POCKET ADAPTOR KIT, 2X4 POCKET ADAPTOR KIT, ACTIVA SC, KINETRA, SOLETRA, INTERSTIM (P960009/S137)Medtronic, Inc.2012-04-12
POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL (P840001/S205)Medtronic Neuromodulation2012-04-12
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S130)Boston Scientific Corp2012-04-10
S-SERIES LAMITRODE LEADS (P010032/S048)ABBOTT MEDICAL2012-04-10
ONYX LIQUID EMBOLIC SYSTEM (P030004/S005)Ev3 Neurovascular2012-04-05
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S131)Boston Scientific Corp2012-04-04
OLYMPIC COOL-CAP SYSTEM (P040025/S012)Natus Medical Incorporated2012-03-27
PIPELINE EMBOLIZATION DEVICE (P100018/S004)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2012-03-22
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S129)Boston Scientific Corp2012-03-09
CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA (P010032/S047)ABBOTT MEDICAL2012-03-02
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S128)Boston Scientific Corp2012-02-29
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S126)Boston Scientific Corp2012-02-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S127)Boston Scientific Corp2012-02-17
VNS THERAPY SYSTEM (P970003/S145)LivaNova USA, Inc.2012-02-06
DEEP BRAIN STIMULATION (DBS) EXTENSION KITS (P960009/S134)Medtronic, Inc.2012-02-03
VNS THERAPY SYSTEM (P970003/S144)LivaNova USA, Inc.2012-02-01
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S124)Boston Scientific Corp2012-02-01
INTREL 3 IMPLANTABLE NEUROSTIMULATORS/SYNERGY/RESTORE FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S203)Medtronic Neuromodulation2012-01-20
SOLETRA/KINETRA NEUROSTIMULATORS/ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S136)Medtronic, Inc.2012-01-20
GENESIS/EON/EON C/EON NEUROSTIMULATION SYSTEMS (P010032/S045)ABBOTT MEDICAL2012-01-19
VNS THERAPY SYSTEM (P970003/S143)LivaNova USA, Inc.2012-01-18
SPINAL CORD STIMULATIONS LEADS (SCS) (P840001/S202)Medtronic Neuromodulation2012-01-13
DEEP BRAIN STIMULATION (DBS) LEADS (P960009/S135)Medtronic, Inc.2012-01-13
RESTORESENSOR IMPLANTABLE NEUROSTIMULATOR (P840001/S201)Medtronic Neuromodulation2012-01-12
EON NEUROSTIMULATION SYSTEMS (P010032/S044)ABBOTT MEDICAL2012-01-06
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S125)Boston Scientific Corp2012-01-04
NOVOCURE NOVOTTF-100A SYSTEM (P100034/S001)Novocure, GmbH2012-01-03
ACTIVA PC/SC/RC/DBS NEUROSTIMULATOR EXTERNAL (P960009/S133)Medtronic, Inc.2011-12-28
SCS NEUROSTIMULATOR EXTERNAL/RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RESTOREADVANCED/RESTORESENSOR (P840001/S200)Medtronic Neuromodulation2011-12-28
VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S142)LivaNova USA, Inc.2011-12-23
VNS THERAPY SYSTEM (P970003/S140)LivaNova USA, Inc.2011-12-20
DURASEAL DURAL SEALANT SYSTEM (P040034/S020)Integra LifeSciences Corporation2011-12-16
DEEP BRAIN STIMULATION (DBS) (P960009/S132)Medtronic, Inc.2011-12-12
SPINAL CORD STIMULATION (SCS) (P840001/S198)Medtronic Neuromodulation2011-12-12
VNS THERAPY SYSTEM (P970003/S141)LivaNova USA, Inc.2011-12-02
ACTIVA (P960009/S130)Medtronic, Inc.2011-11-10
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S197)Medtronic Neuromodulation2011-11-10
ACTIVA FAMILY OF NEUROSTIMULATORS (P960009/S131)Medtronic, Inc.2011-11-10
ACTIVA PC/RC INS & EXTERNAL NEUROSTIMULATOR (P960009/S115)Medtronic, Inc.2011-11-09
VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S139)LivaNova USA, Inc.2011-11-09
RESTOREPRIME/PRIMEADVANCED/RESTORE/RESTOREULTRA/RETSOREADVANCED/EXTERNAL NEUROSTIMULAR INS (P840001/S184)Medtronic Neuromodulation2011-11-09
MEDTRONIC 37085 EXTENSION (P960009/S128)Medtronic, Inc.2011-11-03
7426 SOLETRA IMPLANTABLE NEUROSTIMULATOR (P960009/S129)Medtronic, Inc.2011-11-03
GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS (P010032/S043)ABBOTT MEDICAL2011-11-03
RESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S185)Medtronic Neuromodulation2011-11-03
GENESIS LINE NEUROSTIMULATION (IPG) SYSTEMS (P010032/S039)ABBOTT MEDICAL2011-11-02
VNS THERAPY SYSTEM (P970003/S135)LivaNova USA, Inc.2011-10-31
GENESIS & EON FAMILY OF NEUORSTIMULATION DEVICES (P010032/S041)ABBOTT MEDICAL2011-10-28
VNS THERAPY GENERATORS, LEADS PROGRAMING SOFTWARE, PROGRAMMING WAND AND ASSCCESORY PACK (P970003/S138)LivaNova USA, Inc.2011-10-27
ACTIVA FAMILY INSS (P960009/S127)Medtronic, Inc.2011-10-21
VNS THERAPY SYSTEM (P970003/S137)LivaNova USA, Inc.2011-10-21
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S119)Boston Scientific Corp2011-10-21
RESTOR FAMILY OF IMPLANTABLE NEUROSTIMULATORS (INSS) (P840001/S196)Medtronic Neuromodulation2011-10-21
VNS THERAPY SYSTEM (P970003/S136)LivaNova USA, Inc.2011-10-18
CYBERONICS VNS THERAPY (P970003/S065)LivaNova USA, Inc.2011-10-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S123)Boston Scientific Corp2011-10-12
DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S004)Integra LifeSciences Corporation2011-09-29
EON MINI NEUROSTIMULATION SYSTEM (P010032/S038)ABBOTT MEDICAL2011-09-20
VNS THERAPY SYSTEM (P970003/S134)LivaNova USA, Inc.2011-09-09
VNS THERAPY SYSTEM (P970003/S133)LivaNova USA, Inc.2011-08-31
PIPELINE EMBOLIZATION DEVICE (P100018/S003)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-08-30
VNS THERAPY SYSTEM (P970003/S117)LivaNova USA, Inc.2011-08-26
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S195)Medtronic Neuromodulation2011-08-26
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S125)Medtronic, Inc.2011-08-26
DURASEAL EXACT SPINE SEALANT SYSTEM (P080013/S007)Integra LifeSciences Corporation2011-08-18
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S193)Medtronic Neuromodulation2011-08-17
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S124)Medtronic, Inc.2011-08-17
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S123)Medtronic, Inc.2011-08-17
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S194)Medtronic Neuromodulation2011-08-17
EON C (IPG) NEUROSTIMULATION SYSTEM (P010032/S040)ABBOTT MEDICAL2011-08-12
VNS THERAPY SYSTEM (P970003/S131)LivaNova USA, Inc.2011-08-11
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S122)Medtronic, Inc.2011-08-05
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S192)Medtronic Neuromodulation2011-08-05
VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S132)LivaNova USA, Inc.2011-08-04
VNS THERAPY SYSTEM (P970003/S130)LivaNova USA, Inc.2011-07-29
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S191)Medtronic Neuromodulation2011-07-29
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S121)Medtronic, Inc.2011-07-29
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S121)Boston Scientific Corp2011-07-27
THERAPY PULSE GENERATORS (P970003/S129)LivaNova USA, Inc.2011-07-20
VNS THERAPY SYSTEM PULSE GENERATORS (P970003/S128)LivaNova USA, Inc.2011-07-11
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS/ITREL 3/SYNERGY FAMILY OF INS/SPECIFY SURGICAL LEADS/RESUME SURGICAL LEAD (P840001/S190)Medtronic Neuromodulation2011-07-07
ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS (P960009/S120)Medtronic, Inc.2011-07-07
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