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
2953–2976 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Nov 17, 2005
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
K043367 · GWE
Lace Electronica S.R.L.
Neurology · 344d
Cleared Nov 04, 2005
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
K052182 · GZJ
Shian Jia Meei Enterprise Co., Ltd.
Neurology · 86d
Cleared Nov 02, 2005
NAVIGATION SW HIP 3.1 ON CI
K052213 · HAW
Brainlab AG
Neurology · 79d
Cleared Nov 01, 2005
BIS EEG MONITOR, MODEL BISX4
K052981 · OLW
Aspect Medical Systems, Inc.
Neurology · 8d
Cleared Oct 28, 2005
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
K052112 · IKN
Excel Tech. , Ltd.
Neurology · 85d
Cleared Oct 27, 2005
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
K052904 · JXE
Scientific Imaging, Inc.
Neurology · 13d
Cleared Oct 21, 2005
DEPUY CAS HIP INSTRUMENTATION
K052178 · HAW
DePuy Orthopaedics, Inc.
Neurology · 72d
Cleared Oct 20, 2005
BRC SOFTWARE PRODUCT
K050192 · OLU
Brc Operations Pty Limited
Neurology · 266d
Cleared Oct 20, 2005
AURA-PSG
K050425 · OLV
Astro-Med, Inc.
Neurology · 244d
Cleared Oct 17, 2005
ICY CATHETER, MODEL IC-3893A
K052443 · NCX
Alsius Corp.
Neurology · 41d
Cleared Oct 11, 2005
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A
K051912 · NCX
Alsius Corp.
Neurology · 89d
Cleared Sep 27, 2005
DIGITAL HAND DYNAMOMETER, MODEL SH5003
K052309 · LBB
Saehan Corp.
Neurology · 34d
Cleared Sep 27, 2005
ACTIHEART
K052489 · GWK
Respironics, Inc.
Neurology · 15d
Cleared Sep 26, 2005
AXXESS BUTTERFLY ANCHOR
K052418 · GZB
Advanced Neuromodulation Systems
Neurology · 24d
Cleared Sep 21, 2005
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K052329 · GZI
Innovative Neurotronics, Inc.
Neurology · 27d
Cleared Sep 20, 2005
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A
K051357 · GWF
Digitimer , Ltd.
Neurology · 119d
Cleared Sep 20, 2005
MAYFIELD INFINITY SKULL CLAMP
K051440 · HBL
Integra Lifesciences Corp.
Neurology · 110d
Cleared Sep 16, 2005
BIOBANDS
K051397 · MVV
Biobands Distributors, Inc.
Neurology · 112d
Cleared Sep 16, 2005
NEURODRIVE SYSTEM
K051830 · GZL
Alpha Omega , Ltd.
Neurology · 72d
Cleared Sep 14, 2005
SINGLE AMPLIFIER FOR BOTOX
K051852 · GWL
Allergan, Inc.
Neurology · 68d
Cleared Sep 14, 2005
DUREPAIR DURA REGENERATION MATRIX
K052211 · GXQ
Medtronic Neurosurgery
Neurology · 30d
Cleared Sep 12, 2005
COGNITRACE
K051825 · GWQ
Eemagine Medical Imaging Solutions GmbH
Neurology · 69d
Cleared Sep 09, 2005
BIS EEG MONITOR, MODEL A-3000
K052362 · OLW
Aspect Medical Systems, Inc.
Neurology · 11d
Cleared Sep 08, 2005
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
K051676 · HAW
Mazor Surgical Technologies , Ltd.
Neurology · 77d