Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Neurology ×
6,334 results
505–528 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared May 07, 2024
Medical HAL Lower Limb Type (HAL-ML)
K233695 · PHL
Cyberdyne, Inc.
Neurology · 172d
Cleared Apr 30, 2024
Flexset System
K233403 · GWQ
Zeto, Inc.
Neurology · 209d
Cleared Apr 26, 2024
Bone Anchor (NGS-BA-01)
K233703 · HAW
ClearPoint Neuro, Inc.
Neurology · 161d
Cleared Apr 24, 2024
DORO LUCENT Skull Clamp (1101.001)
K240319 · HBL
Pro-Med Instruments GmbH
Neurology · 82d
Cleared Apr 23, 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
K233329 · NRY
Route 92 Medical, Inc.
Neurology · 207d
Cleared CT Apr 22, 2024
MamaLift Plus
K223515 · SAP
Curio Digital Therapeutics, Inc.
Neurology · 517d
Cleared Apr 19, 2024
Electrical Neuromuscular Stimulator, Cure Trio
K233046 · GZJ
Oriental Inspiration Limited
Neurology · 207d
Cleared Apr 19, 2024
SafeOp 3: Neural Informatix Systeem
K234092 · GWF
Alphatec Spine, Inc.
Neurology · 115d
Cleared Apr 18, 2024
EMBOGUARD Balloon Guide Catheter
K233924 · QJP
Neuravi Limited
Neurology · 127d
Cleared Apr 15, 2024
Glide (91000-GL-X)
K240884 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 14d
Cleared Apr 04, 2024
VSP PEEK Cranial Implant
K231834 · GWO
3D Systems, Inc.
Neurology · 287d
Cleared Apr 03, 2024
Oxevision Sleep Device
K233618 · LEL
Oxehealth Limited
Neurology · 142d
Cleared Mar 30, 2024
Rejoyn
K231209 · SAP
Otsuka America Pharmaceutical, Inc.
Neurology · 338d
Cleared Mar 28, 2024
CustomizedBone Service
K240567 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 28d
Cleared Mar 27, 2024
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
K231425 · NUH
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 315d
Cleared Mar 27, 2024
Modius Stress
K232253 · QJQ
Neurovalens Limited
Neurology · 243d
Cleared Mar 27, 2024
MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter
K233201 · QJP
Penumbra, Inc.
Neurology · 181d
Cleared Mar 25, 2024
Modus IR
K231986 · IZI
Synaptive Medical, Inc.
Neurology · 264d
Cleared Mar 25, 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · GWF
Soterix Medical, Inc.
Neurology · 94d
Cleared Mar 25, 2024
Transcutaneous Electrical Nerve Stimulator (9029SCM)
K240292 · NUH
Hong Kong Etech Groups Limited
Neurology · 53d
Cleared Mar 22, 2024
NeuroStar Advanced Therapy System (All previously cleared models)
K231926 · OBP
Neuronetics, Inc.
Neurology · 266d
Cleared Mar 21, 2024
Electrical Stimulator System
K232439 · NUH
Gymmax Technology Shenzen Co., Ltd.
Neurology · 220d
Cleared Mar 19, 2024
Amydi-med Disposable Non-invasive EEG electrodes
K240668 · GXY
Shenzhen Amydi-Med Electrics Tech...
Neurology · 11d
Cleared Mar 15, 2024
APRO 55 Catheter
K234115 · DQY
Alembic, LLC
Neurology · 79d