Atlas FDA

Neurology

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

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RecordFirmDate
Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology™ (P100018/S037)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2022-11-02
Master Restore, Itrel®, Synergy®, Intellis™, Vanta™ Spinal Cord Stimulation Systems, Pisces™, Specify®, Vectris® Spinal (P840001/S525)Medtronic Neuromodulation2022-11-02
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S080)ABBOTT MEDICAL2022-10-28
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S194)ABBOTT MEDICAL2022-10-28
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S049)Boston Scientific Corp2022-10-27
Saluda Medical Evoke® SCS System (P190002/S001)Saluda Medical Pty, Ltd.2022-10-26
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S530)Medtronic Neuromodulation2022-10-21
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S440)Medtronic, Inc.2022-10-21
Deep Brain Stimulation (DBS) System (P140009/S079)ABBOTT MEDICAL2022-10-17
Senza HFX iQ System, Senza HFX iQ IPG, HFX Trial Stimulator, HFX iQ Remote, HFX iQ Patient Application (P130022/S044)Nevro Corporation2022-10-12
DuraSeal Dural Sealant System (P040034/S035)Integra LifeSciences Corporation2022-10-07
DuraSeal Exact Spine Sealant System (P080013/S024)Integra LifeSciences Corporation2022-10-07
Evoke® SCS System (P190002/S003)Saluda Medical Pty, Ltd.2022-10-06
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S439)Medtronic, Inc.2022-10-04
Senza Spinal Cord Stimulation (SCS) System (P130022/S043)Nevro Corporation2022-09-30
Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® (P840001/S528)Medtronic Neuromodulation2022-09-13
Spinal Cord Stimulation (SCS) (P010032/S190)ABBOTT MEDICAL2022-09-09
Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S526)Medtronic Neuromodulation2022-09-07
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S437)Medtronic, Inc.2022-09-07
Master Restore, Itrel®, Synergy®, IntellisTM Spinal Cord Stimulation Systems, PiscesTM, Specify®, Vectris® Spinal Cord S (P840001/S523)Medtronic Neuromodulation2022-09-01
Activa Deep Brain Stimulation Therapy System (P960009/S436)Medtronic, Inc.2022-08-26
Restore, Itrel, and Synergy Spinal Cord Stimulation Systems, Pisces, Resume, Specify, and Vectris Spinal Cord Stimulatio (P840001/S524)Medtronic Neuromodulation2022-08-26
Proclaim DRG Systems (P150004/S057)ABBOTT MEDICAL2022-08-19
Proclaim SCS Systems (P010032/S187)ABBOTT MEDICAL2022-08-19
Infinity DBS Systems (P140009/S077)ABBOTT MEDICAL2022-08-19
VNS Therapy System (P970003/S233)LivaNova USA, Inc.2022-08-12
Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S434)Medtronic, Inc.2022-08-10
Saluda Medical Evoke SCS System (P190002/S011)Saluda Medical Pty, Ltd.2022-08-09
Surpass Streamline Flow Diverter (P170024/S010)Stryker Neurovascular2022-08-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S433)Medtronic, Inc.2022-08-03
Saluda Medical Evoke SCS System (P190002/S010)Saluda Medical Pty, Ltd.2022-08-03
Exablate Model 4000 Type 1.0 and 1.1 Systems (P150038/S018)Insightec2022-07-29
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S435)Medtronic, Inc.2022-07-28
Apollo Onyx Delivery Micro Catheter 1.5cm, Apollo Onyx Delivery Micro Catheter 3.0cm (P030004/S029)Ev3 Neurovascular2022-07-28
NeuroPace RNS System (P100026/S090)NeuroPace, Inc.2022-07-28
Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO (P170013/S004)MicroVention, Inc.2022-07-28
Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris® Spinal Cord S (P840001/S522)Medtronic Neuromodulation2022-07-28
Saluda Medical Evoke SCS System (P190002/S009)Saluda Medical Pty, Ltd.2022-07-26
Master Restore, Itrel, Synergy and lntellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S514)Medtronic Neuromodulation2022-07-21
Saluda Medical Evoke® SCS System (P190002/S007)Saluda Medical Pty, Ltd.2022-07-14
Saluda Medical Evoke SCS System (P190002/S005)Saluda Medical Pty, Ltd.2022-07-06
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S078)ABBOTT MEDICAL2022-06-30
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S188)ABBOTT MEDICAL2022-06-28
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X (P170013/S009)MicroVention, Inc.2022-06-28
Vercise Genus R32, Vercise Genus R16 (P150031/S050)Boston Scientific Corp2022-06-23
WaveWriter Alpha, WaveWriter Alpha 16 (P030017/S350)Boston Scientific Corp2022-06-23
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S424)Medtronic, Inc.2022-06-15
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S430)Medtronic, Inc.2022-06-09
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S519)Medtronic Neuromodulation2022-06-09
Exablate 4000 (Exablate Neuro) (P150038/S021)Insightec2022-06-07
SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch (P970003/S236)LivaNova USA, Inc.2022-06-06
Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti (P840001/S521)Medtronic Neuromodulation2022-06-02
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S432)Medtronic, Inc.2022-06-02
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S431)Medtronic, Inc.2022-06-01
Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S520)Medtronic Neuromodulation2022-06-01
Saluda Medical Evoke SCS System (P190002/S008)Saluda Medical Pty, Ltd.2022-05-26
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S429)Medtronic, Inc.2022-05-25
Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulat (P840001/S518)Medtronic Neuromodulation2022-05-25
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S428)Medtronic, Inc.2022-05-24
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S427)Medtronic, Inc.2022-05-24
Master Vanta Spinal Cord Stimulation Systems (P840001/S517)Medtronic Neuromodulation2022-05-24
Nevro Corp Senza™ Spinal Cord Stimulation (SCS) System (P130022/S046)Nevro Corporation2022-05-13
Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C (P840001/S499)Medtronic Neuromodulation2022-05-13
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S426)Medtronic, Inc.2022-05-12
Saluda Medical Evoke SCS System (P190002/S006)Saluda Medical Pty, Ltd.2022-05-12
Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St (P840001/S516)Medtronic Neuromodulation2022-05-12
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S425)Medtronic, Inc.2022-05-10
Optune® device (P100034/S029)Novocure, GmbH2022-05-10
Itrel, Synergy, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify, and Vectris Spinal Cord St (P840001/S515)Medtronic Neuromodulation2022-05-10
FRED X System (P180027/S005)MicroVention, Inc.2022-04-26
Saluda Medical Evoke® SCS System (P190002/S004)Saluda Medical Pty, Ltd.2022-04-20
Saluda Medical Evoke® SCS System (P190002/S002)Saluda Medical Pty, Ltd.2022-04-06
Exablate Model 4000 System (P150038/S019)Insightec2022-04-06
Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S419)Medtronic, Inc.2022-04-06
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S048)Boston Scientific Corp2022-04-04
Exablate Model 4000 System (P150038/S020)Insightec2022-03-31
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S423)Medtronic, Inc.2022-03-30
Master Restore, Itrel®, Synergy® and Intellis Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spinal (P840001/S513)Medtronic Neuromodulation2022-03-30
Flow Re-Direction Endoluminal Device (FRED) and FRED X System (P180027/S008)MicroVention, Inc.2022-03-25
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S422)Medtronic, Inc.2022-03-25
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S185)ABBOTT MEDICAL2022-03-24
Vercise Genus DBS System (P150031/S045)Boston Scientific Corp2022-03-24
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S056)ABBOTT MEDICAL2022-03-24
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S076)ABBOTT MEDICAL2022-03-24
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S417)Medtronic, Inc.2022-03-18
Master Restore, Itrel®, Synergy® and IntellisTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vectris® Sp (P840001/S501)Medtronic Neuromodulation2022-03-16
Activa® Deep Brain Stimulation Therapy System. (P960009/S409)Medtronic, Inc.2022-03-16
Adherus ET AutoSpray Dural Sealant, NUS-109 (P130014/S015)Stryker Leibinger GmbH & Co KG2022-03-16
Master Restore, Itrel®, Synergy®, Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectri (P840001/S506)Medtronic Neuromodulation2022-03-14
VNS Therapy PerenniaDURA Model 303 Lead (P970003/S235)LivaNova USA, Inc.2022-03-09
Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System (P180027/S007)MicroVention, Inc.2022-03-01
Saluda Medical Evoke SCS System (P190002)Saluda Medical Pty, Ltd.2022-02-28
Master Restore, Itrel®, Synergy®, IntellisTM and Vanta™ Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S511)Medtronic Neuromodulation2022-02-26
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S420)Medtronic, Inc.2022-02-26
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S421)Medtronic, Inc.2022-02-25
Restore, Itrel®, Synergy® and Intellis™ and Vanta™ Spinal Cord Stimulation Systems and Pisces™, Specify®, and Vectris Sp (P840001/S500)Medtronic Neuromodulation2022-02-18
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S408)Medtronic, Inc.2022-02-18
Intellis Spinal Cord Stimulation System (SCS Systems) (P840001/S510)Medtronic Neuromodulation2022-02-17
Dorsal Root Ganglion (DRG) System (P150004/S055)ABBOTT MEDICAL2022-02-17
Spinal Cord Stimulation (SCS) System (P010032/S184)ABBOTT MEDICAL2022-02-17
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Every clearance here is in the API, with alerts when new ones post.