Atlas FDA

Neurology

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

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RecordFirmDate
Proliv™Rx System (P250010)Neurolief , Ltd.2025-12-31
Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092)ABBOTT MEDICAL2025-12-23
Proclaim™ Spinal Cord Stimulation (SCS) System (P010032/S246)ABBOTT MEDICAL2025-12-23
Infinity™ Deep Brain Stimulation (DBS) System (P140009/S127)ABBOTT MEDICAL2025-12-23
Master Restore; Itrel; Synergy; Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Ve (P840001/S616)Medtronic Neuromodulation2025-12-22
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (P840001/S614)Medtronic Neuromodulation2025-12-18
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
DuraSeal Dural Sealant System (P040034/S040)Integra LifeSciences Corporation2025-12-17
VNS THERAPY SYSTEM (P970003/S252)LivaNova USA, Inc.2025-12-17
DuraSeal Exact Spine Sealant System (P080013/S029)Integra LifeSciences Corporation2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set (P990040/S034)Cerenovus, Inc.2025-12-16
Vercise Genus™ Deep Brain Stimulation (DBS) Systems (P150031/S089)Boston Scientific Corp2025-12-10
WaveWriter Alpha™ Prime Spinal Cord Stimulation (SCS) Systems (P030017/S389)Boston Scientific Corp2025-12-10
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08
Onyx Liquid Embolic System (LES) (P030004/S035)Ev3 Neurovascular2025-12-08
Flow FL-100 (P230024)Flow Neuroscience AB2025-12-08
Altius® Direct Electrical Nerve Stimulation System (P230020/S005)Neuros Medical, Inc.2025-12-03
Activa™ Deep Brain Stimulation Therapy System, Percept PC BrainSense™ (P960009/S525)Medtronic, Inc.2025-11-26
Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Ve (P840001/S613)Medtronic Neuromodulation2025-11-26
VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand (P970003/S251)LivaNova USA, Inc.2025-11-25
Medtronic DBS Therapy for Dystonia (P960009/S482)Medtronic, Inc.2025-11-22
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S521)Medtronic, Inc.2025-11-13
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ (P840001/S610)Medtronic Neuromodulation2025-11-13
Saluda Medical Evoke® SCS System (P190002/S045)Saluda Medical Pty, Ltd.2025-11-08
Deep Brain Stimulation (DBS) Neurostimulation System (P140009/S124)ABBOTT MEDICAL2025-11-07
Spinal Cord Stimulation (SCS) Neurostimulation System (P010032/S243)ABBOTT MEDICAL2025-11-07
SpineSeal™ Spine Sealant (P240027/S004)Pramand, LLC2025-11-07
Dorsal Root Ganglion (DRG) Neurostimulation System (P150004/S090)ABBOTT MEDICAL2025-11-07
Adherus AutoSpray Dural Sealant (P130014/S021)Stryker Leibinger GmbH & Co KG2025-11-06
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S508)Medtronic, Inc.2025-11-04
Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (P840001/S596)Medtronic Neuromodulation2025-11-04
Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S013)MicroVention, Inc.2025-11-02
Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock (P210037/S013)Biotronik Nro, Inc.2025-10-23
Optune Gio™ - Maxpoint Version 2.0 (P100034/S041)Novocure, GmbH2025-10-23
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S523)Medtronic, Inc.2025-10-23
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe (P840001/S612)Medtronic Neuromodulation2025-10-23
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S522)Medtronic, Inc.2025-10-16
Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and (P840001/S611)Medtronic Neuromodulation2025-10-16
CraniSeal Dural Sealant (P220014/S009)Pramand, LLC2025-10-10
Infinity™ DBS System (P140009/S122)ABBOTT MEDICAL2025-09-26
Proclaim™ DRG System (P150004/S088)ABBOTT MEDICAL2025-09-26
Proclaim™ SCS System (P010032/S241)ABBOTT MEDICAL2025-09-26
DBS Neurostimulation System (P140009/S125)ABBOTT MEDICAL2025-09-25
DRG Neurostimulation System (P150004/S091)ABBOTT MEDICAL2025-09-25
SCS Neurostimulation System (P010032/S244)ABBOTT MEDICAL2025-09-25
Flow Re-Direction Endoluminal Device (FRED) X System (P180027/S012)MicroVention, Inc.2025-09-20
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S087)Boston Scientific Corp2025-09-19
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S386)Boston Scientific Corp2025-09-19
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS Neurostimulator Implantable B35200); (DBS Ne (P960009/S518)Medtronic, Inc.2025-09-18
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (P840001/S606)Medtronic Neuromodulation2025-09-18
FRED X System (P180027/S014)MicroVention, Inc.2025-09-18
Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (P840001/S607)Medtronic Neuromodulation2025-09-15
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S519)Medtronic, Inc.2025-09-15
VNS Therapy® System (P970003/S250)LivaNova USA, Inc.2025-09-12
Eterna™ SCS IPG (P010032/S240)ABBOTT MEDICAL2025-09-07
Liberta RC™ DBS IPG (P140009/S121)ABBOTT MEDICAL2025-09-07
VNS Therapy System (P970003/S248)LivaNova USA, Inc.2025-09-05
Master Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify (P840001/S605)Medtronic Neuromodulation2025-09-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S517)Medtronic, Inc.2025-09-05
Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S242)ABBOTT MEDICAL2025-08-29
Proclaim™ Doral Root Ganglion (DRG) IPG (P150004/S089)ABBOTT MEDICAL2025-08-29
Infinity™ Deep Brain Stimulation (DBS) IPG (P140009/S123)ABBOTT MEDICAL2025-08-29
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe (P840001/S604)Medtronic Neuromodulation2025-08-28
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S516)Medtronic, Inc.2025-08-28
CraniSeal­­ Dural Sealant (P220014/S008)Pramand, LLC2025-08-25
TRUFILL n-BCA Liquid Embolic System (P990040/S036)Cerenovus, Inc.2025-08-22
Saluda Medical Evoke SCS System (P190002/S041)Saluda Medical Pty, Ltd.2025-08-21
Surpass Streamline Flow Diverter (P170024/S024)Stryker Neurovascular2025-08-20
NeuroPace® RNS® System (P100026/S099)NeuroPace, Inc.2025-08-18
Senza® HFX iQ™ System (P130022/S067)Nevro Corporation2025-08-15
Pipeline™ Vantage Embolization Device with Shield Technology™ (P100018/S048)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-08-14
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ (P840001/S602)Medtronic Neuromodulation2025-08-14
Master Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems (P840001/S603)Medtronic Neuromodulation2025-08-06
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S515)Medtronic, Inc.2025-08-06
SetPoint System (P240039)SetPoint Medical2025-07-30
Model A71100 Restore Clinician Programmer Application (CPA) and Model A71200 Vanta™/Sequentia™ LT Clinician Programmer A (P840001/S594)Medtronic Neuromodulation2025-07-29
Liberta RC™ DBS IPG (Model 62400) (P140009/S118)ABBOTT MEDICAL2025-07-28
Eterna™ SCS IPG (Model 32400) (P010032/S236)ABBOTT MEDICAL2025-07-28
Proclaim DRG IPG (P150004/S087)ABBOTT MEDICAL2025-07-23
Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™, (P840001/S601)Medtronic Neuromodulation2025-07-22
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S513)Medtronic, Inc.2025-07-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S510)Medtronic, Inc.2025-07-17
Master Restore, Itrel®, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify®, a (P840001/S598)Medtronic Neuromodulation2025-07-17
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™, Spe (P840001/S599)Medtronic Neuromodulation2025-07-17
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S511)Medtronic, Inc.2025-07-17
Restore; Itrel; Synergy Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Vectris Sp (P840001/S600)Medtronic Neuromodulation2025-07-16
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S512)Medtronic, Inc.2025-07-16
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S506)Medtronic, Inc.2025-07-15
Saluda Medical Evoke SCS System (P190002/S043)Saluda Medical Pty, Ltd.2025-07-10
Exablate Model 4000 Type-1 System (P150038/S037)Insightec2025-07-03
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S509)Medtronic, Inc.2025-07-03
Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™, Specify™ (P840001/S597)Medtronic Neuromodulation2025-07-03
Proclaim SCS IPG (P010032/S239)ABBOTT MEDICAL2025-07-02
Proclaim DRG IPG (P150004/S086)ABBOTT MEDICAL2025-07-02
CraniSeal Dural Sealant (P220014/S005)Pramand, LLC2025-07-02
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Every clearance here is in the API, with alerts when new ones post.