Atlas FDA

Neurology

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

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RecordFirmDate
Optune (P100034/S030)Novocure, GmbH2024-01-16
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense (P960009/S467)Medtronic, Inc.2024-01-11
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S557)Medtronic Neuromodulation2024-01-11
Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S066)Boston Scientific Corp2024-01-10
Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit (P150004/S068)ABBOTT MEDICAL2024-01-10
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S369)Boston Scientific Corp2024-01-09
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S069)Boston Scientific Corp2024-01-09
ReActiv8 Implantable Neurostimulation System (P190021/S001)Mainstay Medical Limited2024-01-08
Master Activa®, Percept and SenSight Deep Brain Stimulation Therapy System (P960009/S438)Medtronic, Inc.2024-01-08
Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro) (P150038/S032)Insightec2024-01-08
Pain RC Spinal Cord Stimulation System (SCS) System (P840001/S527)Medtronic Neuromodulation2024-01-08
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S368)Boston Scientific Corp2023-12-29
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S067)Boston Scientific Corp2023-12-29
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S468)Medtronic, Inc.2023-12-29
CraniSeal Dural Sealant (P220014/S001)Pramand, LLC2023-12-23
CraniSeal Dural Sealant (P220014/S002)Pramand, LLC2023-12-20
Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor (P150004/S063)ABBOTT MEDICAL2023-12-19
Charger, Model 16000 (P010032/S206)ABBOTT MEDICAL2023-12-19
Saluda Medical Evoke SCS System (P190002/S018)Saluda Medical Pty, Ltd.2023-12-19
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S550)Medtronic Neuromodulation2023-12-12
Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S462)Medtronic, Inc.2023-12-12
Evoke SCS System (P190002/S022)Saluda Medical Pty, Ltd.2023-12-12
Nevro Corp Senza® Spinal Cord Stimulation (SCS) System (P130022/S054)Nevro Corporation2023-12-12
Surpass Evolve Flow Diverter Systems (P170024/S015)Stryker Neurovascular2023-12-05
Vercise Genus DBS System (P150031/S062)Boston Scientific Corp2023-11-30
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S555)Medtronic Neuromodulation2023-11-30
(LGW, QRB) - Master Restore Spinal Cord Stimulation Systems (P840001/S549)Medtronic Neuromodulation2023-11-29
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S466)Medtronic, Inc.2023-11-29
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spin (P840001/S556)Medtronic Neuromodulation2023-11-29
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S461)Medtronic, Inc.2023-11-29
Proclaim DRG IPG (P150004/S052)ABBOTT MEDICAL2023-11-27
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S014)MicroVention, Inc.2023-11-24
WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System (P030017/S365)Boston Scientific Corp2023-11-06
Onyx™ Liquid Embolic System (P030004/S030)Ev3 Neurovascular2023-11-03
Spinal Cord Stimulation (SCS) Legacy Charger Systems and Accessories (P010032/S207)ABBOTT MEDICAL2023-10-27
Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories (P140009/S090)ABBOTT MEDICAL2023-10-27
Eterna SCS IPG (P010032/S205)ABBOTT MEDICAL2023-10-26
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S063)Boston Scientific Corp2023-10-25
Pipeline Vantage Embolization Device with Shield Technology (P100018/S042)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2023-10-25
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S367)Boston Scientific Corp2023-10-25
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S465)Medtronic, Inc.2023-10-19
Master Intellis™ Spinal Cord Stimulation Systems (P840001/S553)Medtronic Neuromodulation2023-10-19
Master IntellisTM and VantaTM Spinal Cord Stimulation Systems (P840001/S554)Medtronic Neuromodulation2023-10-19
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S464)Medtronic, Inc.2023-10-18
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S552)Medtronic Neuromodulation2023-10-18
Activa® Deep Brain Stimulation Therapy System, Percept™ BrainSense™ (P960009/S463)Medtronic, Inc.2023-10-12
Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro) (P150038/S025)Insightec2023-10-12
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® Spinal C (P840001/S551)Medtronic Neuromodulation2023-10-12
Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™ (P100018/S041)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2023-10-10
Vercise Genus™ DBS Systems, Vercise Gevia™ DBS System, Vercise™ PC DBS System (P150031/S060)Boston Scientific Corp2023-10-10
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S455)Medtronic, Inc.2023-10-10
Intellis™ and Vanta™ Spinal Cord Stimulation Systems (P840001/S544)Medtronic Neuromodulation2023-10-10
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S019)Stryker Leibinger GmbH & Co KG2023-10-07
Eterna SCS System (P010032/S200)ABBOTT MEDICAL2023-10-05
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A (P030017/S357)Boston Scientific Corp2023-10-05
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S015)MicroVention, Inc.2023-10-04
Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P010032/S204)ABBOTT MEDICAL2023-09-29
Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P140009/S089)ABBOTT MEDICAL2023-09-29
TRUFILL™ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S031)Cerenovus, Inc.2023-09-29
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories (P150004/S067)ABBOTT MEDICAL2023-09-29
NeuroPace® RNS® System (P100026/S087)NeuroPace, Inc.2023-09-28
Precision™, Precision Spectra™, Precision Novi™, Precision Montage™, Precision Montage™ MRI, Spectra WaveWriter, WaveWri (P030017/S366)Boston Scientific Corp2023-09-27
Vercise™ PC, Vercise Gevia™, Vercise Genus™ Deep Brain Stimlation (DBS) Systems (P150031/S061)Boston Scientific Corp2023-09-27
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S460)Medtronic, Inc.2023-09-26
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S203)ABBOTT MEDICAL2023-09-22
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S066)ABBOTT MEDICAL2023-09-22
Percept™ PC INS with BrainSense™ (Model B35200) (P960009/S445)Medtronic, Inc.2023-09-22
Sequentia™ LT INS (Model 977005), Vanta™ INS with AdaptiveStim™ (Model 977006) (P840001/S535)Medtronic Neuromodulation2023-09-22
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S088)ABBOTT MEDICAL2023-09-22
Saluda Medical Evoke® SCS System (P190002/S014)Saluda Medical Pty, Ltd.2023-09-22
VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand (P970003/S241)LivaNova USA, Inc.2023-09-15
Pipeline Vantage Embolization Device with Shield Technology (P100018/S034)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2023-09-15
Surpass Evolve™ Flow Diverter Stent System (P170024/S013)Stryker Neurovascular2023-09-12
Pipeline™ Flex Embolization Device, Pipeline™ Flex Embolization Device with Shield Technology™ (P100018/S040)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2023-09-06
Vercise S8 Adapter (P150031/S055)Boston Scientific Corp2023-09-06
DuraSeal Exact Spine Sealant System (P080013/S027)Integra LifeSciences Corporation2023-09-05
DuraSeal Dural Sealant System (P040034/S038)Integra LifeSciences Corporation2023-09-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S459)Medtronic, Inc.2023-09-05
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (P840001/S548)Medtronic Neuromodulation2023-09-05
NeuroPace® RNS® System (P100026/S094)NeuroPace, Inc.2023-08-28
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S018)Stryker Leibinger GmbH & Co KG2023-08-25
Infinity Deep Brain Stimulation (DBS) System (P140009/S086)ABBOTT MEDICAL2023-08-25
ReActiv8 Implantable Neurostimulation System (P190021/S005)Mainstay Medical Limited2023-08-24
Reactiv8 Implantable Neurostimulation System (P190021/S006)Mainstay Medical Limited2023-08-15
Optune System (P100034/S031)Novocure, GmbH2023-08-14
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S458)Medtronic, Inc.2023-08-10
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (P840001/S546)Medtronic Neuromodulation2023-08-10
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S457)Medtronic, Inc.2023-08-10
Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spin (P840001/S547)Medtronic Neuromodulation2023-08-10
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S201)ABBOTT MEDICAL2023-08-09
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S064)ABBOTT MEDICAL2023-08-09
Master Intellis Spinal Cord Stimulation Systems (P840001/S529)Medtronic Neuromodulation2023-08-08
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S456)Medtronic, Inc.2023-08-03
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (P840001/S545)Medtronic Neuromodulation2023-08-03
HFX App (P130022/S049)Nevro Corporation2023-08-01
Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav (P150038/S028)Insightec2023-07-27
Spinal Cord Stimulation (SCS) System (P010032/S195)ABBOTT MEDICAL2023-07-27
Exablate Model 4000 System (P150038/S031)Insightec2023-07-27
Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav (P150038/S027)Insightec2023-07-27
Infinity Deep Brain Stimulation (DBS) System (P140009/S081)ABBOTT MEDICAL2023-07-27
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Every clearance here is in the API, with alerts when new ones post.