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
1729–1752 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 31, 2016
AxoGuard Nerve Connector
K162741 · JXI
Cook Biotech Incorporated
Neurology · 31d
Cleared Oct 30, 2016
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W,...
K161282 · GXY
Medico Electrodes International , Ltd.
Neurology · 177d
Cleared Oct 28, 2016
Codman EDS3 CSF External Drainage System
K162437 · JXG
Codman & Shurtleff, Inc.
Neurology · 58d
Cleared Oct 27, 2016
Smart External Drain (SED) System
K161605 · JXG
Aqueduct Critical Care, Inc.
Neurology · 139d
Cleared Oct 20, 2016
HICP200 Patient/Monitor Interconnect Cable
K161010 · GWM
Innerspace Neuro Solutions, Inc.
Neurology · 192d
Cleared Oct 19, 2016
TENS Electrodes
K160081 · GXY
Cathay Manufacturing Corp.
Neurology · 278d
Cleared Oct 18, 2016
Neuromonitoring Kit
K161893 · PDQ
SI-BONE, Inc.
Neurology · 99d
Cleared Oct 14, 2016
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K161912 · MOF
Asahi Intecc Co., Ltd.
Neurology · 94d
Cleared Oct 13, 2016
OTC TENS Device, Model PTS-IV
K161537 · NUH
Counter Scientific Development (Gz),...
Neurology · 132d
Cleared Oct 06, 2016
SimulCare II(TM)
K160246 · GZJ
Xanacare Technologies, LLC
Neurology · 248d
Cleared Oct 05, 2016
Painmaster MCT Patch
K151995 · NUH
Newmark, Inc.
Neurology · 443d
Cleared Sep 30, 2016
Traxcess .007 Mini Guidewire
K161803 · MOF
MicroVention, Inc.
Neurology · 92d
Cleared Sep 27, 2016
Biopor Porous Polyethylene Implants
K161446 · GWO
Ceremed , Inc.
Neurology · 125d
Cleared Sep 23, 2016
VSP Cranial System
K151285 · PPT
3D Systems, Inc.
Neurology · 498d
Cleared CT Sep 22, 2016
Ahead 300
K161068 · PIW
Brainscope Company, Inc.
Neurology · 160d
Cleared Sep 22, 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt...
K161992 · JXG
Integra LifeSciences Corporation
Neurology · 65d
Cleared Sep 21, 2016
Solitaire Platinum Revascularization Device
K161879 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 75d
Cleared Sep 20, 2016
Personal Kinetigraph (PKG) System
K161717 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 90d
Cleared Sep 17, 2016
KARL STORZ Flexible Video-Neuro-Endoscope System
K161112 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 150d
Cleared Sep 15, 2016
TEMPEDY
K152946 · NCX
Seiratherm GmbH
Neurology · 345d
Cleared Sep 15, 2016
HBOTC Muscle and Nerve Stimulator
K160255 · NUH
Hb Medical, Inc.
Neurology · 227d
Cleared Sep 14, 2016
StealthStation System with Cranial Software
K153660 · HAW
Medtronic Navigation, Inc.
Neurology · 268d
Cleared Sep 11, 2016
NeuroStar TMS Therapy System
K161519 · OBP
Neuronetics, Inc.
Neurology · 101d
Cleared Sep 09, 2016
Self-retaining Retractor
K161004 · GZT
Fetzer Medical GmbH & Co. KG
Neurology · 151d