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Neurology

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

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RecordFirmDate
VNS THERAPY SYSTEM (P970003/S096)LivaNova USA, Inc.2008-02-22
ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM (P010032/S024)ABBOTT MEDICAL2008-02-07
OLYMPIC COOL-CAP SYSTEM (P040025/S006)Natus Medical Incorporated2008-02-05
SPINAL CORD STIMULATION (P840001/S105)Medtronic Neuromodulation2008-01-17
ITREL3,SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IMPLANTABLE PULSE GENERATOR OR INPLANTABLE NEUROSTIMULATOR (P840001/S099)Medtronic Neuromodulation2008-01-11
KINETRA & SOLETRA FAMILY OF NEUROSTIMULATOR (P960009/S043)Medtronic, Inc.2008-01-11
RESTOREULTRA RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S097)Medtronic Neuromodulation2008-01-08
VNS THERAPY SYSTEM (P970003/S093)LivaNova USA, Inc.2007-12-21
VNS THERAPY SYSTEM (P970003/S091)LivaNova USA, Inc.2007-12-20
VNS THERAPY SYSTEM (P970003/S090)LivaNova USA, Inc.2007-12-20
VNS THERAPY SYSTEM (P970003/S095)LivaNova USA, Inc.2007-12-19
VNS THERAPY SYSTEM (P970003/S094)LivaNova USA, Inc.2007-12-19
SPINAL CORD STIMULATION (P840001/S103)Medtronic Neuromodulation2007-12-18
VNS THERAPY SYSTEM (P970003/S077)LivaNova USA, Inc.2007-12-14
EON AND GENESIS RC NEUROSTIMULATION SYSTEMS (P010032/S019)ABBOTT MEDICAL2007-12-13
ITREL 3, SYNERGY, RESTORE PRIME & PRIME ADVANCED FAMILY OF IPGS OR IMPLANTABLE NEUROSTIMULATOR (P840001/S104)Medtronic Neuromodulation2007-12-11
KINETRA & SOLETRA FAMILY OF NEUROSTIMULATORS (P960009/S045)Medtronic, Inc.2007-12-11
ANS EON C (IPG) NEUROSTIMULATION SYSTEM (P010032/S021)ABBOTT MEDICAL2007-12-10
TRUFIL N-BCA LIQUID EMBOLIC SYSTEM (P990040/S006)Cerenovus, Inc.2007-11-30
PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S028)Boston Scientific Corp2007-11-21
VNS THERAPY SYSTEM (P970003/S092)LivaNova USA, Inc.2007-11-14
ITREL 3,RESTORE,RESTORE ADVANCED IMPLANTABLE NEUROSTIMULATOR (P840001/S101)Medtronic Neuromodulation2007-11-08
SOLETRA NEUROSTIMULATOR (P960009/S044)Medtronic, Inc.2007-11-08
EON NEUROSTIMULATION SYSTEM (P010032/S022)ABBOTT MEDICAL2007-11-05
CONNECTOR-M1 (P030017/S025)Boston Scientific Corp2007-10-30
VNS THERAPY SYSTEM (P970003/S085)LivaNova USA, Inc.2007-10-23
ACTIVA THERAPY FOR DEEP BRAIN STIMULATION (P960009/S042)Medtronic, Inc.2007-10-17
TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S005)Cerenovus, Inc.2007-10-15
VNS THERAPY SYSTEM (P970003/S089)LivaNova USA, Inc.2007-10-11
ONYX LIQUID EMBOLIC SYSTEM (P030004/S003)Ev3 Neurovascular2007-10-09
VNS THERAPY PULSE & PULSE DUO GENERATORS (P970003/S088)LivaNova USA, Inc.2007-09-21
COOL CAP SYSTEM (P040025/S005)Natus Medical Incorporated2007-09-21
VNS THERAPY SYSTEM (P970003/S087)LivaNova USA, Inc.2007-09-04
VNS THERAPY SYSTEM (P970003/S086)LivaNova USA, Inc.2007-08-30
PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM INTRODUCER (P030017/S022)Boston Scientific Corp2007-07-18
VNS THERAPY SYSTEM (P970003/S076)LivaNova USA, Inc.2007-06-29
VNS THERAPY SYSTEM (P970003/S079)LivaNova USA, Inc.2007-06-29
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S023)Boston Scientific Corp2007-06-29
VNS THERAPY SYSTEM (P970003/S084)LivaNova USA, Inc.2007-06-28
VNS THERAPY SYSTEM (P970003/S082)LivaNova USA, Inc.2007-06-15
GENESIS, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S020)ABBOTT MEDICAL2007-06-11
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATOR SYSTEMS (P840001/S096)Medtronic Neuromodulation2007-06-11
DURASEAL DURAL SEALANT SYSTEM (P040034/S009)Integra LifeSciences Corporation2007-06-11
PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM (P030017/S020)Boston Scientific Corp2007-05-29
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S024)Boston Scientific Corp2007-05-14
VNS THERAPY PULSE GENERATORS (P970003/S081)LivaNova USA, Inc.2007-05-14
VNS THERAPY SYSTEM (P970003/S080)LivaNova USA, Inc.2007-05-10
CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS (P960034/S002)Abbott Medical Optics, Inc.2007-05-08
PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S021)Boston Scientific Corp2007-04-13
VNS THERAPY SYSTEM (P970003/S078)LivaNova USA, Inc.2007-04-12
DURASEAL DURAL SEALANT SYSTEM (P040034/S008)Integra LifeSciences Corporation2007-03-29
PRECISION SPINAL CORD STIMULATION SYSTEM (P030017/S018)Boston Scientific Corp2007-03-09
MEDTRONIC RESTORE FAMILY IMPLANTABLE NEUROSTIMULATORS (P840001/S095)Medtronic Neuromodulation2007-03-07
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S019)Boston Scientific Corp2007-03-02
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S017)Boston Scientific Corp2007-02-15
VNS THERAPY SYSTEM (P970003/S075)LivaNova USA, Inc.2007-02-12
VNS THERAPY SYSTEM (P970003/S068)LivaNova USA, Inc.2007-02-08
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S016)Boston Scientific Corp2007-02-01
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S013)Boston Scientific Corp2006-12-21
OLYMPIC COOL-CAP (P040025)Natus Medical Incorporated2006-12-20
DURASEAL DURAL SEALANT SYSTEM (P040034/S006)Integra LifeSciences Corporation2006-12-04
ONYX LIQUID EMBOLIC SYSTEM (P030004/S002)Ev3 Neurovascular2006-11-29
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S015)Boston Scientific Corp2006-11-17
DURASEAL DURAL SEALANT SYSTEM (P040034/S003)Integra LifeSciences Corporation2006-11-17
VNS THERAPY SYSTEM (P970003/S073)LivaNova USA, Inc.2006-11-02
DURASEAL DURAL SEALANT SYSTEM (P040034/S007)Integra LifeSciences Corporation2006-11-02
VNS THERAPY SYSTEM (P970003/S072)LivaNova USA, Inc.2006-11-02
VNS THERAPY SYSTEM (P970003/S074)LivaNova USA, Inc.2006-10-31
VNS THERAPY SYSTEM (P970003/S071)LivaNova USA, Inc.2006-10-17
MEDTRONIC ACTIVA THERAPY SYSTEM (P960009/S040)Medtronic, Inc.2006-10-05
DURASEAL DURAL SEALANT SYSTEM (P040034/S005)Integra LifeSciences Corporation2006-09-15
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S070)LivaNova USA, Inc.2006-09-05
VNS THERAPY SYSTEM (P970003/S069)LivaNova USA, Inc.2006-08-09
DURASEAL DURAL SEALANT SYSTEM (P040034/S004)Integra LifeSciences Corporation2006-08-02
ACTIVA PARKINSONS CONTROL THERAPY (P960009/S039)Medtronic, Inc.2006-07-27
RESTORE ADVANCED, PRIME ADVANCED, RESTORE PRIME, RESTORE, SYNERGY PLUS, SYNERGY COMPACT+, SYNERGY (P840001/S093)Medtronic Neuromodulation2006-07-18
RESTORE ADVANCED & PRIME ADVANCED NEUROSTIMULATIONS SYSTEMS (P840001/S092)Medtronic Neuromodulation2006-07-07
VNS THERAPY PULSE GENERATOR, LEAD AND PATIENT KIT (P970003/S063)LivaNova USA, Inc.2006-06-29
VNS THERAPY PERENNIA MODEL 303 LEAD (P970003/S067)LivaNova USA, Inc.2006-06-22
ONYX LIQUID EMBOLIC SYSTEM (P030004/S001)Ev3 Neurovascular2006-06-22
VNS THERAPY SYSTEM (P970003/S066)LivaNova USA, Inc.2006-06-08
TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM (P990040/S004)Cerenovus, Inc.2006-06-01
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S014)Boston Scientific Corp2006-05-24
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM IPG/ETS 3.0 (P030017/S012)Boston Scientific Corp2006-05-12
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S064)LivaNova USA, Inc.2006-05-04
MEDTRONIC RESTORE IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S090)Medtronic Neuromodulation2006-03-31
RESTOREPRIME IMPLANTABLE NEUROSTIMULATION SYSTEM (P840001/S089)Medtronic Neuromodulation2006-03-17
TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM (P990040/S002)Cerenovus, Inc.2006-03-07
TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM (P990040/S003)Cerenovus, Inc.2006-03-07
MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS (P960009/S036)Medtronic, Inc.2006-03-02
MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM (P960009/S037)Medtronic, Inc.2006-03-01
SYNERGY VERSITREL, KINETRA (P840001/S083)Medtronic Neuromodulation2006-02-16
ITREL 3, SOLETRA, DCI (SYNERGY) (P960009/S033)Medtronic, Inc.2006-02-16
MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+ (P840001/S091)Medtronic Neuromodulation2006-02-08
ITREL3 (P840001/S084)Medtronic Neuromodulation2006-01-30
MEDTRONIC NEUROSTIMULATION SYSTEMS (RESTORE, SYNERGY, SYNERGY VERSITREL, SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+) (P840001/S088)Medtronic Neuromodulation2006-01-26
NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM (P970003/S062)LivaNova USA, Inc.2005-12-28
GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S018)ABBOTT MEDICAL2005-12-21
DURASEAL DURAL SEALANT SYSTEM (P040034/S002)Integra LifeSciences Corporation2005-12-13
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S011)Boston Scientific Corp2005-12-09
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