FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
25–48 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jun 18, 2026
3D MAC Titanium Cranial Plate (TCP) System
K253116 · GXN
The Surgeon General, Department of...
Neurology · 267d
Cleared Jun 17, 2026
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
K253055 · GYD
Nordic Kinetics AB
Neurology · 268d
Cleared Jun 16, 2026
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
K260425 · NUH
Hivox Biotek, Inc.
Neurology · 126d
Cleared Jun 15, 2026
Permatage XT Settable Bone Putty
K261265 · GXP
Orthocon, Inc.
Neurology · 60d
Cleared Jun 13, 2026
Enobio Dx (Enobio Dx 8)
K261604 · GWQ
Neuroelectrics Barcelona S.L.U.
Neurology · 30d
Cleared Jun 12, 2026
Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
K253015 · OLU
VoxNeuro, Inc.
Neurology · 266d
Cleared Jun 11, 2026
UNEEG EpiSight System
K253607 · SEM
Uneeg Medical A/S
Neurology · 205d
Cleared Jun 10, 2026
Penumbra System (Thunderbolt Aspiration Tubing)
K250690 · NRY
Penumbra, Inc.
Neurology · 460d
Cleared Jun 09, 2026
BOBBY Balloon Guide Catheter
K261549 · QJP
MicroVention, Inc., d/b/a Terumo Neuro
Neurology · 29d
Cleared Jun 08, 2026
Apollo Quattro (APQ-10M)
K253542 · IPF
Weero Co., Ltd.
Neurology · 206d
Cleared Jun 05, 2026
EyeBOX SNAP
K254086 · QEA
Oculogica, Inc.
Neurology · 169d
Cleared Jun 04, 2026
Precision S 4K Sinuscope
K253602 · GWG
Stryker Endoscopy
Neurology · 198d
Cleared Jun 03, 2026
BioWave BioWraps
K261522 · GXY
Biowave Corporation
Neurology · 27d
Cleared Jun 03, 2026
MeRT System
K260402 · SIG
Wave Neuroscience
Neurology · 117d
Cleared Jun 03, 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · NFO
Touchbeauty Beauty & Health...
Neurology · 133d
Cleared Jun 02, 2026
High Tone Power therapy (HiToP) (Model: HiToP PNP)
K252816 · IPF
Mohammadali Nezakati
Neurology · 271d
Cleared May 28, 2026
Ulike Clear Zero (YC10 BU)
K260895 · NFO
Guangxi Ulike Medical Technology Co.,...
Neurology · 71d
Cleared May 28, 2026
STIMPOD NMS460 Nerve Stimulator
K252712 · GZJ
Algiamed Technologies USA, Inc.
Neurology · 274d
Cleared May 22, 2026
Apollo TMS Therapy System
K260560 · OBP
Mag & More GmbH
Neurology · 92d
Cleared May 22, 2026
MagVenture Accelerated TMS (aTMS) Therapy System
K260189 · OBP
Tonica Elektronik A/S
Neurology · 120d
Cleared May 22, 2026
Zenith Distal Access Long Sheath
K253359 · QJP
Suzhou Zenith Vascular SciTech Limited
Neurology · 234d
Cleared May 20, 2026
Numen™ Helia Coil Embolization System
K260351 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 106d
Cleared May 20, 2026
Zenith Aspiration Catheter
K252707 · NRY
Suzhou Zenith Vascular SciTech Limited
Neurology · 266d
Cleared May 13, 2026
Portable Neuromodulation Stimulator (PoNS)
K253061 · QCF
Helius Medical, Inc.
Neurology · 233d