FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
1681–1704 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Nov 21, 2016
Electronic Pulse Stimulator
K160508 · NUH
Beijing Choice Electronic Technololgy...
Neurology · 271d
Cleared Nov 10, 2016
Solitaire 2 Revascularization Device
K162539 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 59d
Cleared Nov 08, 2016
Cadwell AmpliScan
K161027 · OMA
Cadwell Industries, Inc.
Neurology · 210d
Cleared Nov 04, 2016
Trex_HD
K162595 · GWQ
Natus Medical Incorporated Dba...
Neurology · 50d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370 · GXQ
Medtronic Neurosurgery
Neurology · 169d
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 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