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
1729–1752 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Not Cleared Jul 15, 2016
EPIC ClearView System
DEN150004 · PNA
Epic Research & Diagnostics, Inc.
Neurology · 549d
Cleared Jul 14, 2016
PMT Platinum Depthalon Depth Electrode
K151790 · GZL
Pmt Corporation
Neurology · 379d
Cleared Jul 13, 2016
EXACTECH GPS
K152764 · HAW
Blue Ortho
Neurology · 293d
Cleared Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161640 · NRY
Penumbra, Inc.
Neurology · 28d
Cleared Jul 09, 2016
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K153272 · GXI
Relievant Medsystems
Neurology · 240d
Cleared Jun 24, 2016
BrightMatter Guide with BrightMatter Pointer
K160523 · HAW
Synaptive Medical, Inc.
Neurology · 120d
Cleared Jun 23, 2016
SANDMAN ELITE
K153353 · OLZ
Embla Systems
Neurology · 216d
Cleared Jun 22, 2016
NERBRIDGE
K152967 · JXI
Toyobo Co., Ltd.
Neurology · 258d
Cleared Jun 22, 2016
Target Detachable Coils
K161429 · HCG
Stryker Neurovascular
Neurology · 30d
Cleared Jun 18, 2016
Kerrison Rongeurs
K152734 · HAE
Vitalitec Medizintechnik GmbH
Neurology · 270d
Cleared Jun 12, 2016
Cranial COVER
K160739 · GXR
Neos Surgery S.L
Neurology · 87d
Cleared Jun 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161064 · NRY
Penumbra, Inc.
Neurology · 58d
Cleared Jun 10, 2016
DSG Threaded Drill System
K152747 · PDQ
Spineguard S.A.
Neurology · 261d
Cleared Jun 10, 2016
NeuroStar TMS Therapy System
K160703 · OBP
Neuronetics, Inc.
Neurology · 88d
Cleared Jun 09, 2016
Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover
K152342 · GXR
St Jude Medical
Neurology · 295d
Cleared Jun 03, 2016
Background Pattern Classification [BPc(TM)]
K152301 · OMA
Natus Medical Incorporated Dba...
Neurology · 294d
Cleared Jun 03, 2016
Disposable Concentric Needle electrodes, Disposable Monopolar Needle...
K152984 · IKT
Bio Protech, Inc.
Neurology · 238d
Cleared Jun 03, 2016
Strive
K153704 · GZJ
Djo, LLC
Neurology · 163d
Cleared Jun 03, 2016
Heat Pain Pro
K160115 · NUH
Omron Healthcare, Inc.
Neurology · 136d
Cleared May 26, 2016
Stivax
K152571 · BWK
Biegler GmbH
Neurology · 260d
Cleared May 25, 2016
ActTrust
K151784 · LEL
Condor Instruments Ltda. - Epp
Neurology · 329d
Cleared May 25, 2016
Penumbra System, Penumbra Pump MAX
K160449 · NRY
Penumbra, Inc.
Neurology · 97d
Cleared May 24, 2016
Hypocore
K153162 · NCX
Novocor Medical Systems, Inc.
Neurology · 204d
Cleared May 20, 2016
CUR Model 1
K160052 · NUH
Thimble Bioelectronics, Inc.
Neurology · 130d