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
3193–3216 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Feb 25, 2004
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474,...
K033395 · GXO
Codman & Shurtleff, Inc.
Neurology · 125d
Cleared Feb 25, 2004
BISX
K040183 · OLW
Aspect Medical Systems, Inc.
Neurology · 29d
Cleared Feb 20, 2004
SMARTEP-ASSR, MODEL M811007
K031051 · GWJ
Intelligent Hearing Systems
Neurology · 324d
Cleared Feb 18, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS
K033223 · HAW
Zimmer, Inc.
Neurology · 135d
Cleared Feb 18, 2004
ADAM
K033978 · GWQ
Astro-Med, Inc.
Neurology · 57d
Cleared Feb 18, 2004
SANDMAN SD20 AMPLIFIER
K040113 · GWL
Eb Neuro S.P.A.
Neurology · 29d
Cleared Feb 17, 2004
VECTORVISION CRANIAL/ENT
K023651 · HAW
Brainlab AG
Neurology · 475d
Cleared Feb 13, 2004
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K032619 · HCG
Surgica Corp.
Neurology · 171d
Cleared Feb 12, 2004
ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS
K033011 · HAW
Zimmer, Inc.
Neurology · 139d
Cleared Feb 12, 2004
LEKSELL SURGIPLAN WITH IMAGEMERGE
K033340 · HAW
Elekta Instrument AB
Neurology · 118d
Cleared Feb 06, 2004
SEDLINE WITH FRONTAL PSI
K033999 · OLW
Physiometrix, Inc.
Neurology · 44d
Cleared Feb 04, 2004
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
K033761 · HCG
Biocompatibles UK Limited
Neurology · 64d
Cleared Feb 04, 2004
MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE
K033813 · HCG
Micrus Corp.
Neurology · 57d
Cleared Jan 30, 2004
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM
K033757 · GZB
Advanced Neuromodulation Systems
Neurology · 60d
Cleared Jan 27, 2004
NDI PASSIVE SPHERES
K033621 · HAW
Northern Digital, Inc.
Neurology · 70d
Cleared Jan 23, 2004
SONOSENS
K033193 · NKI
Friendly Sensors AG
Neurology · 113d
Cleared Jan 16, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · HBE
Stryker Instruments
Neurology · 175d
Cleared Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · OLW
Aspect Medical Systems, Inc.
Neurology · 353d
Cleared Jan 15, 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · GZJ
Biomedical Life Systems, Inc.
Neurology · 77d
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT...
K033850 · JXG
Medtronic Neurosurgery
Neurology · 33d
Cleared Jan 09, 2004
SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
K033372 · HCG
Micro Therapeutics, Inc.
Neurology · 79d
Cleared Jan 07, 2004
COMPREHENSIVE NEUROMUSCULAR PROFILER
K031995 · IKN
Medical Technologies Unlimited, Inc.
Neurology · 194d
Cleared Jan 07, 2004
PREMIER PLUS
K032003 · GZJ
American Imex
Neurology · 194d
Cleared Jan 07, 2004
SEA-BAND
K033268 · MVV
Sea-Band UK , Ltd.
Neurology · 90d