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
2977–3000 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 07, 2005
BIO-STIM KIT
K050174 · GZJ
Skylark Device & Systems Co., Ltd.
Neurology · 225d
Cleared Sep 06, 2005
E-STIM II
K050435 · GZJ
Lhasa Oms, Inc.
Neurology · 196d
Cleared Sep 02, 2005
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
K051874 · OLW
Physiometrix, Inc.
Neurology · 53d
Cleared Aug 31, 2005
OPTI-AMP DC-POWERED
K052060 · GWL
Intelligent Hearing Systems
Neurology · 33d
Cleared Aug 26, 2005
CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
K052066 · OLV
Bio-Logic Systems Corp.
Neurology · 25d
Cleared Aug 23, 2005
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
K052145 · OLW
Ge Healthcare
Neurology · 15d
Cleared Aug 23, 2005
CUTANEOUS ELECTRODE
K052188 · GXY
Rhythmlink International, LLC
Neurology · 12d
Cleared Aug 17, 2005
MEE-1000A NEUROMASTER
K051178 · GWF
Nihon Kohden America, Inc.
Neurology · 100d
Cleared Aug 17, 2005
RESOLVE OPEN BACK HALO RINGS
K051918 · HAX
Jerome Medical
Neurology · 33d
Cleared Aug 17, 2005
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · GXZ
Excel Tech. , Ltd.
Neurology · 13d
Cleared Aug 15, 2005
ECLIPSE NEUROLOGICAL WORKSTATION
K050798 · GWF
Axon Systems, Inc.
Neurology · 139d
Cleared Aug 05, 2005
DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG...
K051883 · OLT
Ge Healthcare
Neurology · 24d
Cleared Aug 04, 2005
AMBU NEUROLINE GROUND
K051529 · GXY
Ambu, Inc.
Neurology · 56d
Cleared Jul 28, 2005
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
K051773 · GZB
Medtronic Inc.,Neurological Division.
Neurology · 27d
Cleared Jul 27, 2005
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
K050651 · HAW
Medtronic Navigation, Inc.
Neurology · 135d
Cleared Jul 19, 2005
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND...
K051599 · GWM
Neurorecovery, Inc.
Neurology · 33d
Cleared Jul 19, 2005
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724 · HAW
Ebi, L.P.
Neurology · 22d
Cleared Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
K050739 · JXG
Codman & Shurtleff, Inc.
Neurology · 119d
Cleared Jul 15, 2005
THE ODFS DROPPED FOOT STIMULATOR
K050991 · GZI
Department of Medical Physics and...
Neurology · 87d
Cleared Jul 11, 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · GWF
Nuvasive, Inc.
Neurology · 45d
Cleared Jun 29, 2005
MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
K051448 · NTU
Medoc Ltd. Advanced Medical Systems
Neurology · 27d
Cleared Jun 28, 2005
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
K050954 · HCG
MicroVention, Inc.
Neurology · 74d
Cleared Jun 28, 2005
NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR
K051560 · HCG
Micro Therapeutics, Inc.
Neurology · 15d
Cleared Jun 27, 2005
FES CYCLE ERGOMETER, MODEL RT300-S
K050036 · GZI
Restorative Therapies, Inc.
Neurology · 171d