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
2329–2352 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jul 25, 2011
CIRCUMAURAL ADHESIVE REPLACEMENT
K111555 · GWJ
R & D Medical Products, Inc.
Neurology · 52d
Cleared Jul 19, 2011
ENTROPY EASYFIT SENSOR
K103129 · GWQ
Ge Healthcare
Neurology · 270d
Cleared Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381 · JXG
Integra LifeSciences Corporation
Neurology · 416d
Cleared Jun 30, 2011
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
K110967 · OMC
Neuralynx, Inc.
Neurology · 85d
Cleared Jun 29, 2011
WAVEGUARD (TM) EEG CAP
K110223 · GXY
Eemagine Medical Imaging Solutions GmbH
Neurology · 155d
Cleared Jun 24, 2011
EPIDUCER LEAD DELIVERY SYSTEM
K110609 · LHG
St Jude Medical
Neurology · 113d
Cleared Jun 24, 2011
MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
K110684 · GXN
Vanduzen Dba Medcad
Neurology · 105d
Cleared Jun 20, 2011
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
K110509 · LIH
Everyway Medical Instruments Co.,Ltd
Neurology · 118d
Cleared Jun 17, 2011
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
K111131 · IKT
Carefusion 209, Inc.
Neurology · 57d
Cleared Jun 03, 2011
IPLAN
K101627 · HAW
Brainlab AG
Neurology · 359d
Cleared Jun 03, 2011
OWL CANNULAE
K102566 · GXI
Diros Technology, Inc.
Neurology · 269d
Cleared Jun 03, 2011
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40
K102614 · GXY
Bio-Medical Research, Ltd.
Neurology · 266d
Cleared May 13, 2011
HI-DOW-XP
K102598 · NUH
Hi-Dow International, Inc.
Neurology · 245d
Cleared May 09, 2011
DIOPSYS NOVA VEP VISION TESTING SYSTEM
K101763 · GWE
Diopsys, Inc.
Neurology · 320d
Cleared May 09, 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K110751 · JXG
Codman & Shurtleff, Inc.
Neurology · 52d
Cleared May 05, 2011
TITAN
K103760 · GWJ
Interacoustics A/S
Neurology · 133d
Cleared May 05, 2011
OWL RF PROBES
K110593 · GXI
Diros Technology, Inc.
Neurology · 64d
Cleared Apr 29, 2011
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
K103343 · GZI
Bioness, Inc.
Neurology · 165d
Cleared Apr 28, 2011
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K103758 · HCG
MicroVention, Inc.
Neurology · 126d
Cleared Apr 19, 2011
NATUS SLEEPWORKS, MODEL 104017
K090277 · OLZ
Excel-Tech Ltd. (Xltek)
Neurology · 804d
Cleared Apr 18, 2011
AOI CRANIAL HELMET
K103362 · MVA
Advanced Orthopro, Inc.
Neurology · 152d
Cleared Apr 14, 2011
KELYNIAM CUSTOM SKULL IMPLANT (CSI)
K103582 · GXN
Kelyniam Global, Inc.
Neurology · 127d
Cleared Apr 08, 2011
NICOLET WIRELESS EEG
K103140 · GWL
Carefusion 209, Inc.
Neurology · 165d
Cleared Apr 08, 2011
PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT...
K110563 · MVV
Therapeutics 101, Inc (Dba Pressure...
Neurology · 39d