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
169–192 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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
Cleared Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003...
K252146 · NFO
Shenzhen Siken 3D Technology...
Neurology · 167d
Cleared Dec 23, 2025
VEINOPLUS Back
K251958 · NUH
Dynapulse Medical
Neurology · 181d
Cleared Dec 22, 2025
EmbraceMini
K252981 · LEL
Empatica S.R.L.
Neurology · 96d
Cleared Dec 14, 2025
Hypnos (369054-200)
K250851 · OLZ
Cadwell Industries, Inc.
Neurology · 268d
Cleared Dec 11, 2025
Target Detachable Coil
K252694 · HCG
Stryker Neurovascular
Neurology · 107d
Cleared Dec 10, 2025
Intellidrop
K251598 · JXG
Brainspace, Inc.
Neurology · 197d
Cleared Dec 08, 2025
Ceribell Delirium Monitor System
K251936 · NCG
Ceribell, Inc.
Neurology · 167d