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Neurology

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

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RecordFirmDate
Onyx™ Liquid Embolic System (P030004/S033)Ev3 Neurovascular2024-07-26
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S220)ABBOTT MEDICAL2024-07-26
WaterWriter Alpha Spinal Cord Stimulator (SCS) Systems (P030017/S376)Boston Scientific Corp2024-07-26
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (P840001/S568)Medtronic Neuromodulation2024-07-25
Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Sp (P840001/S567)Medtronic Neuromodulation2024-07-25
Genesis and EON Family Neurostimulation (IPG) System (P010032/S216)ABBOTT MEDICAL2024-07-24
Brio Neurostimulation System (P140009/S098)ABBOTT MEDICAL2024-07-24
Axium Neurostimulator System (P150004/S073)ABBOTT MEDICAL2024-07-24
SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance (P970003/S244)LivaNova USA, Inc.2024-07-18
Percept RC BrainSense (P960009/S484)Medtronic, Inc.2024-07-17
DRG Delivery Sheath (P150004/S075)ABBOTT MEDICAL2024-07-17
Inceptiv Spinal Cord Stimulation Systems (P840001/S566)Medtronic Neuromodulation2024-07-17
Optune Gio (P100034/S034)Novocure, GmbH2024-07-12
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S033)Cerenovus, Inc.2024-07-02
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S474)Medtronic, Inc.2024-07-01
Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock (P210037/S008)Biotronik Nro, Inc.2024-07-01
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Class III; Prospera SCS System (P210037/S007)Biotronik Nro, Inc.2024-06-28
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S481)Medtronic, Inc.2024-06-28
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S480)Medtronic, Inc.2024-06-27
Family of DBS IPGs (P140009/S095)ABBOTT MEDICAL2024-06-26
Family of SCS IPGs (P010032/S213)ABBOTT MEDICAL2024-06-26
Surpass Elite Flow Diverter System (P170024/S017)Stryker Neurovascular2024-06-26
Family of DRG IPGs (P150004/S071)ABBOTT MEDICAL2024-06-26
Precision Spional Cord Stimulator (SCS) Systems (P030017/S375)Boston Scientific Corp2024-06-21
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S074)Boston Scientific Corp2024-06-21
Restore, Itrel, Synergy, Intellis Vanta, and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris S (P840001/S565)Medtronic Neuromodulation2024-06-20
Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock (P210037/S005)Biotronik Nro, Inc.2024-06-13
Pipeline™ Vantage Embolization Device with Shield Technology™ (P100018/S043)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-06-06
Surpass Evolve Flow Diverter System (P170024/S016)Stryker Neurovascular2024-05-30
Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System (P130022/S056)Nevro Corporation2024-05-29
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S479)Medtronic, Inc.2024-05-23
Master Restore Spinal Cord Stimulation Systems, Itrel® Spinal Cord Stimulation Systems, Synergy® Spinal Cord Stimulation (P840001/S564)Medtronic Neuromodulation2024-05-23
Surpass Elite Flow Diverter System (P170024/S012)Stryker Neurovascular2024-05-18
Deep Brain Stimulation (DBS) External Pulse Generator (EPG), Infinity DBS EPG Base (P140009/S097)ABBOTT MEDICAL2024-05-16
Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Proclaim SCS EPG Base (P010032/S215)ABBOTT MEDICAL2024-05-16
Alternative Active Anchor (part number 104504) (P190002/S027)Saluda Medical Pty, Ltd.2024-05-16
Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base (P150004/S072)ABBOTT MEDICAL2024-05-16
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S068)Boston Scientific Corp2024-05-14
Liberta RC™ DBS IPG (P140009/S092)ABBOTT MEDICAL2024-05-02
Eterna™ SCS IPG (P010032/S210)ABBOTT MEDICAL2024-05-02
Saluda Medical Evoke® SCS System; Implantable Pulse Generator (Model 3042) (P190002/S025)Saluda Medical Pty, Ltd.2024-05-01
Eterna SCS IPG (P010032/S214)ABBOTT MEDICAL2024-04-30
Liberta RC DBS IPG (P140009/S096)ABBOTT MEDICAL2024-04-30
WaveWriter Alpha SCS System (P030017/S371)Boston Scientific Corp2024-04-29
Activa Deep Brain Stimulation Therapy System, Percept PC and RC BrainSense (P960009/S477)Medtronic, Inc.2024-04-26
Intellis, Sequentia LT, and Vanta Spinal Cord Stimulation Systems (P840001/S563)Medtronic Neuromodulation2024-04-26
Pipeline™ Flex Embolization Device with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec (P100018/S044)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-04-25
Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int (P840001/S512)Medtronic Neuromodulation2024-04-24
SCS Neurostimulators Implantable Itrel Family (P840001/S561)Medtronic Neuromodulation2024-04-24
DBS Neurostimulators Implantable Activa Family (P960009/S475)Medtronic, Inc.2024-04-24
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S476)Medtronic, Inc.2024-04-24
Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S562)Medtronic Neuromodulation2024-04-24
Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm (P030004/S031)Ev3 Neurovascular2024-04-16
Percept™ RC BrainSense™ (P960009/S472)Medtronic, Inc.2024-04-11
Senza® Spinal Cord Stimulation (SCS) System (P130022/S057)Nevro Corporation2024-04-11
Senza Spinal Cord Stimulation (SCS) System (P130022/S053)Nevro Corporation2024-04-10
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S559)Medtronic Neuromodulation2024-04-09
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S470)Medtronic, Inc.2024-04-09
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S212)ABBOTT MEDICAL2024-04-05
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S070)ABBOTT MEDICAL2024-04-05
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S094)ABBOTT MEDICAL2024-04-05
mySCS™ GO Therapy Controller App (P030017/S358)Boston Scientific Corp2024-04-04
Saluda Medical Evoke SCS System (P190002/S020)Saluda Medical Pty, Ltd.2024-03-25
Saluda Medical Evoke® SCS System (P190002/S019)Saluda Medical Pty, Ltd.2024-03-20
Evoke SCS System (P190002/S021)Saluda Medical Pty, Ltd.2024-03-19
SenTiva™ Generator, SenTiva Duo™ Generator (P970003/S243)LivaNova USA, Inc.2024-03-15
Prospera SCS System, Resilience Surgical Lead (P210037/S003)Biotronik Nro, Inc.2024-03-13
Vercise Deep Brain Stimulation (DBS) Systems (Vercise Genus™ R32, Vercise Genus™ R16) (P150031/S071)Boston Scientific Corp2024-03-13
Precision Spinal Cord Stimulator (SCS) Systems (WaveWriter Alpha™, WaveWriter Alpha™ 16) (P030017/S373)Boston Scientific Corp2024-03-13
Surpass Evolve Flow Diverter System (P170024/S014)Stryker Neurovascular2024-03-12
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S473)Medtronic, Inc.2024-02-29
Evoke® SCS System (P190002/S024)Saluda Medical Pty, Ltd.2024-02-29
Evoke® SCS System (P190002/S026)Saluda Medical Pty, Ltd.2024-02-29
Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System (P150031/S064)Boston Scientific Corp2024-02-29
Exablate (P150038/S034)Insightec2024-02-27
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S070)Boston Scientific Corp2024-02-26
Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro (P150038/S035)Insightec2024-02-26
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S372)Boston Scientific Corp2024-02-26
DBS Neurostimulator Implantable (P960009/S471)Medtronic, Inc.2024-02-23
SCS Neurostimulator Implantable (P840001/S560)Medtronic Neuromodulation2024-02-23
DBS Neurostimulators External, DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Activa F (P960009/S469)Medtronic, Inc.2024-02-22
SCS Neurostimulators External, SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore F (P840001/S558)Medtronic Neuromodulation2024-02-22
DBS System - Lead and Extension (P140009/S084)ABBOTT MEDICAL2024-02-21
Senza Spinal Cord Stimulation (SCS) System (P130022/S055)Nevro Corporation2024-02-21
Saluda Medical Evoke SCS System; Active Anchor Kit-L (P190002/S023)Saluda Medical Pty, Ltd.2024-02-20
Prospera SCS System Next Generation Active Anchor, TrueLock (P210037/S002)Biotronik Nro, Inc.2024-02-15
TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set (P990040/S032)Cerenovus, Inc.2024-02-13
Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System (P030017/S363)Boston Scientific Corp2024-02-05
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S012)MicroVention, Inc.2024-02-05
Spinal Cord Stimulation (SCS) Leads (P010032/S209)ABBOTT MEDICAL2024-02-02
Optune (P100034/S032)Novocure, GmbH2024-02-02
Infinity Deep Brain Stimulation (DBS) Leads (P140009/S091)ABBOTT MEDICAL2024-02-02
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S370)Boston Scientific Corp2024-01-25
Infinion™ Pro Leads (P030017/S354)Boston Scientific Corp2024-01-24
Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application (P140009/S087)ABBOTT MEDICAL2024-01-24
Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application (P010032/S202)ABBOTT MEDICAL2024-01-24
DRG System - Leads and Extensions (P150004/S065)ABBOTT MEDICAL2024-01-22
Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”) (P150038/S033)Insightec2024-01-21
LVIS (P170013/S011)MicroVention, Inc.2024-01-17
FRED (P180027/S010)MicroVention, Inc.2024-01-17
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