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
97–120 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Feb 13, 2026
PreOp v3
K252565 · OLX
Clouds of Care
Neurology · 183d
Cleared Feb 13, 2026
STAR RF Ablation System
K251802 · GXI
Merit Medical Systems, Inc.
Neurology · 246d
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032 · QJP
Stryker Neurovascular
Neurology · 142d
Cleared Feb 09, 2026
Ceribell Instant EEG Headset
K254033 · GXY
Ceribell, Inc.
Neurology · 55d
Cleared Feb 05, 2026
Encora X1
K251517 · QBC
Encora, Inc.
Neurology · 265d
Cleared Feb 02, 2026
CHIKAI Nexus petit
K252011 · MOF
Asahi Intecc Co., Ltd.
Neurology · 220d
Cleared Jan 27, 2026
Optima Coil System (OptiOne Coil System)
K254221 · HCG
Balt USA, LLC
Neurology · 29d
Cleared Jan 21, 2026
Affirm 400
K251286 · QFX
Digital Surgery Systems, Inc. (D.B.A...
Neurology · 271d
Cleared Jan 17, 2026
NeuroSpan Bridge
K253363 · JXI
Auxilium Biotechnologies, Inc.
Neurology · 109d
Cleared Jan 16, 2026
actiTENS mini
K252767 · GZJ
Sublimed
Neurology · 140d
Cleared Jan 16, 2026
Toro 88 Superbore Catheter
K252297 · QJP
Toro Neurovascular, Inc.
Neurology · 177d
Not Cleared Jan 16, 2026
Sana Device
DEN250005 · QYN
Sana Health
Neurology · 319d
Cleared Jan 15, 2026
Esperance pHLO Aspiration System
K251357 · NRY
Phenox, Ltd.
Neurology · 260d
Cleared Jan 14, 2026
METICULY Patient-specific titanium mesh implant
K252958 · GXN
Meticuly Co., Ltd.
Neurology · 120d
Cleared Jan 11, 2026
SafeOp 3: Neural Informatix System
K252842 · GWF
Alphatec Spine, Inc.
Neurology · 125d
Cleared Jan 07, 2026
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery...
K253308 · PPT
Materialise NV
Neurology · 100d
Cleared Jan 06, 2026
V-DAC Catheter
K251097 · QJP
Vesalio, Inc.
Neurology · 271d
Cleared Jan 05, 2026
SurfRider 13 Microcatheter
K251668 · QJP
Kaneka Americas Holding, Inc.
Neurology · 220d
Cleared Jan 02, 2026
MONTAGE XT Cranial Cement
K253854 · GXP
Orthocon, Inc.
Neurology · 30d
Cleared Dec 31, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · NUH
Shenzhen Jiantuo Electronics Co., Ltd.
Neurology · 93d
Cleared Dec 31, 2025
Genesis Sleep
K252951 · QJQ
Neurofield, Inc.
Neurology · 106d
Cleared Dec 23, 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Dec 23, 2025
Sim&Size
K253122 · PZO
Sim&Cure
Neurology · 89d
Cleared Dec 23, 2025
Aura Glide (FC40)
K252187 · NFO
Aura Medical, LLC
Neurology · 162d