Atlas FDA

Neurology

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

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RecordFirmDate
Altius® Direct Electrical Nerve Stimulation System (P230020/S001)Neuros Medical, Inc.2024-12-19
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S037)Ev3 Neurovascular2024-12-19
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S495)Medtronic, Inc.2024-12-18
NeuroPace Remote Monitor (P100026/S097)NeuroPace, Inc.2024-12-18
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S379)Boston Scientific Corp2024-12-18
Restore Spinal Cord Stimulation System, Itrel® Spinal Cord Stimulation System, Synergy® Spinal Cord Stimulation System, (P840001/S583)Medtronic Neuromodulation2024-12-18
Optune® Gio (P100034/S038)Novocure, GmbH2024-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S079)Boston Scientific Corp2024-12-18
Saluda Medical Evoke SCS System (P190002/S031)Saluda Medical Pty, Ltd.2024-12-16
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S492)Medtronic, Inc.2024-12-13
Spinal Cord Stimulation (SCS) Leads, Extensions, & Adapters (P010032/S230)ABBOTT MEDICAL2024-12-13
Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock (P210037/S009)Biotronik Nro, Inc.2024-12-13
Deep Brain Stimulation (DBS) Extensions & Adapters (P140009/S112)ABBOTT MEDICAL2024-12-13
Axium Neurostimulator System (P150004/S081)ABBOTT MEDICAL2024-12-13
Sequentia LT and Vanta Spinal Cord Stimulation Systems (P840001/S580)Medtronic Neuromodulation2024-12-13
DBS Neurostimulator Implantable/Activia Family (P960009/S493)Medtronic, Inc.2024-12-12
SCS Neurostimulators Implantable Itrel Family/Restore Family (P840001/S581)Medtronic Neuromodulation2024-12-12
ReActiv8 Implantable Neurostimulation System (P190021/S008)Mainstay Medical Limited2024-12-12
NEUROPACE RNS SYSTEM (P100026/S096)NeuroPace, Inc.2024-12-11
Optune Gio (P100034/S037)Novocure, GmbH2024-12-10
Neuroform Atlas Stent System (P180031/S010)Stryker Neurovascular2024-12-09
Master Intellis™ Spinal Cord Stimulation System, Vanta™ Spinal Cord Stimulation System, Inceptiv™ Spinal Cord Stimulati (P840001/S584)Medtronic Neuromodulation2024-12-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S496)Medtronic, Inc.2024-12-05
Infinity™ Deep Brain Stimulation (DBS) IPG (P140009/S107)ABBOTT MEDICAL2024-12-03
Senza Spiral Cord Stimulation (SCS) System (P130022/S062)Nevro Corporation2024-12-03
Senza Spinal Cord Stimulation (SCS) System (P130022/S064)Nevro Corporation2024-12-03
Proclaim™ Doral Root Ganglion (DRG) IPG (P150004/S077)ABBOTT MEDICAL2024-12-03
Senza Spiral Cord Stimulation (SCS) System (P130022/S063)Nevro Corporation2024-12-03
Saluda Medical Evoke SCS System (P190002/S017)Saluda Medical Pty, Ltd.2024-12-03
Proclaim™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S226)ABBOTT MEDICAL2024-12-03
SCS EPG 2-Port Header (Model 3042) (P010032/S217)ABBOTT MEDICAL2024-11-22
Saluda Medical Evoke® SCS System (P190002/S032)Saluda Medical Pty, Ltd.2024-11-22
Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectr (P840001/S578)Medtronic Neuromodulation2024-11-18
Neuroform Atlas Stent System (P180031/S009)Stryker Neurovascular2024-11-18
VNS Therapy System (P970003/S245)LivaNova USA, Inc.2024-11-14
Eterna™ SCS Charging System (P010032/S225)ABBOTT MEDICAL2024-11-13
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S065)Boston Scientific Corp2024-11-13
Liberta RC™ DBS Charging System (P140009/S106)ABBOTT MEDICAL2024-11-13
Saluda Medical Evoke® SCS System (P190002/S033)Saluda Medical Pty, Ltd.2024-11-07
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S378)Boston Scientific Corp2024-11-07
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S036)Ev3 Neurovascular2024-11-07
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S078)Boston Scientific Corp2024-11-07
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, Vectris® S (P840001/S576)Medtronic Neuromodulation2024-11-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S488)Medtronic, Inc.2024-11-05
Senza Spinal Cord Stimulation (SCS) Systems (P130022/S050)Nevro Corporation2024-11-01
Saluda Medical Evoke SCS System (P190002/S028)Saluda Medical Pty, Ltd.2024-10-31
DuraSeal Dural Sealant System (P040034/S039)Integra LifeSciences Corporation2024-10-30
DuraSeal Exact Spine Sealant System (P080013/S028)Integra LifeSciences Corporation2024-10-30
Optune Gio (P100034/S033)Novocure, GmbH2024-10-30
SCS Implantable Neurostimulators (P840001/S574)Medtronic Neuromodulation2024-10-28
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S108)ABBOTT MEDICAL2024-10-24
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S078)ABBOTT MEDICAL2024-10-24
Senza Spinal Cord Stimulation (SCS) System (P130022/S051)Nevro Corporation2024-10-16
Surpass Elite Flow Diverter System (P170024/S018)Stryker Neurovascular2024-10-16
Vanta™ Spinal Cord Stimulation Systems (P840001/S573)Medtronic Neuromodulation2024-10-11
Percept™ Deep Brain Stimulation Therapy System (P960009/S487)Medtronic, Inc.2024-10-11
Saluda Medical Evoke® SCS System (P190002/S030)Saluda Medical Pty, Ltd.2024-10-10
Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive (P150038/S036)Insightec2024-10-08
Genesis Neurostimulation System (P010032/S211)ABBOTT MEDICAL2024-10-08
Axium Neurostimulator System (P150004/S069)ABBOTT MEDICAL2024-10-08
Brio Neurostimulation System (P140009/S093)ABBOTT MEDICAL2024-10-08
Surpass Evolve Flow Diverter Systems, Surpass Elite Flow Diverter Systems (P170024/S021)Stryker Neurovascular2024-10-06
Optune System (P100034/S035)Novocure, GmbH2024-09-24
Senza Spinal Cord Stimulation (SCS) System and HFX iQ System (P130022/S058)Nevro Corporation2024-09-24
Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S017)MicroVention, Inc.2024-09-23
Apollo™ Onyx™ Delivery Micro Catheter (P030004/S034)Ev3 Neurovascular2024-09-20
Neuroform Atlas® Stent System (P180031/S008)Stryker Neurovascular2024-09-20
Neuroform Atlas® Stent System (P180031/S007)Stryker Neurovascular2024-09-20
Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology (P100018/S047)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-09-20
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S105)ABBOTT MEDICAL2024-09-18
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S224)ABBOTT MEDICAL2024-09-18
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S485)Medtronic, Inc.2024-09-16
Master Spinal Cord Stimulation (SCS) Systems (P840001/S571)Medtronic Neuromodulation2024-09-16
Master Restore, Itrel® and VantaTM Spinal Cord Stimulation Systems (P840001/S572)Medtronic Neuromodulation2024-09-16
Surpass Evolve and Elite Flow Diverter (P170024/S020)Stryker Neurovascular2024-09-05
Vercise Genus™ Deep Brain Stimulation (DBS) Systems (P150031/S077)Boston Scientific Corp2024-09-04
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S020)Stryker Leibinger GmbH & Co KG2024-08-29
Altius® Direct Electrical Nerve Stimulation System (P230020)Neuros Medical, Inc.2024-08-26
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S223)ABBOTT MEDICAL2024-08-23
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S104)ABBOTT MEDICAL2024-08-23
Prospera SCS System (P210037/S004)Biotronik Nro, Inc.2024-08-23
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) (P150004/S076)ABBOTT MEDICAL2024-08-23
Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr (P170013/S012)MicroVention, Inc.2024-08-21
Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S011)MicroVention, Inc.2024-08-21
Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S016)MicroVention, Inc.2024-08-14
NeuroPace RNS System (P100026/S095)NeuroPace, Inc.2024-08-13
Deep Brain Stimulation (DBS) (P140009/S102)ABBOTT MEDICAL2024-08-08
Spinal Cord Stimulation (SCS) (P010032/S221)ABBOTT MEDICAL2024-08-08
Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S073)Boston Scientific Corp2024-08-06
Surpass Evolve Flow Diverter Systems (P170024/S019)Stryker Neurovascular2024-08-05
Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1 (P140009/S099)ABBOTT MEDICAL2024-08-02
Patient Controller Application Version 2.0.2 (P010032/S218)ABBOTT MEDICAL2024-08-02
SCS Implantable Neurostimulators (P840001/S569)Medtronic Neuromodulation2024-07-31
Eterna™ SCS IPG (P010032/S219)ABBOTT MEDICAL2024-07-31
Liberta RC™ DBS IPG (P140009/S100)ABBOTT MEDICAL2024-07-31
Intellis Spinal Cord Stimulation Systems (P840001/S570)Medtronic Neuromodulation2024-07-29
Senza Spinal Cord Stimulation (SCS) System (P130022/S059)Nevro Corporation2024-07-27
Vercise Genus Deep Brain Stimulation (DBS) Systems (P150031/S075)Boston Scientific Corp2024-07-26
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S101)ABBOTT MEDICAL2024-07-26
Pipeline™ Flex Embolization Device with Shield Technology™, Pipeline™ Vantage Embolization Device with Shield Technology (P100018/S046)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-07-26
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Every clearance here is in the API, with alerts when new ones post.