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
1321–1344 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 18, 2019
Aurora Surgiscope System
K182211 · GWG
Rebound Therapeutics Corporation
Neurology · 156d
Cleared Jan 17, 2019
DL Self-adhesive Electrode
K182111 · GXY
Shaoxing DL Healthcare Co., Ltd.
Neurology · 164d
Cleared Jan 17, 2019
Esprit Nova
K182227 · OLZ
Neurozone Msh Incorporated
Neurology · 154d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · GWM
Integra Lifesciences Corp.
Neurology · 32d
Cleared Jan 10, 2019
Maxpower Relief
K182120 · NUH
Omron Healthcare, Inc.
Neurology · 157d
Cleared Jan 02, 2019
Polaris RF Ablation System
K181864 · GXD
Baylis Medical Company, Inc.
Neurology · 174d
Cleared Jan 02, 2019
ClearUP Sinus Pain Relief
K182025 · GZJ
Tivic Health Systems, Inc.
Neurology · 156d
Cleared Jan 02, 2019
Optimus Neuro System
K183352 · GWO
Osteonic Co., Ltd.
Neurology · 30d
Not Cleared Dec 28, 2018
EyeBOX
DEN170091 · QEA
Oculogica, Inc.
Neurology · 371d
Cleared Dec 20, 2018
Embrace
K181861 · POS
Empatica S.R.L.
Neurology · 161d
Cleared Dec 20, 2018
microTargeting Guideline 4000 5.0 System
K183123 · GZL
FHC, Inc.
Neurology · 37d
Cleared Dec 19, 2018
Modified BrainScope One
K181785 · PIW
Brainscope Company, Inc.
Neurology · 169d
Cleared Dec 18, 2018
NuFACE FIX Skin Toning Device
K182424 · NFO
Carol Cole Company Dba Nuface
Neurology · 103d
Cleared Dec 18, 2018
Riptide Aspiration System (Riptide Large Bore Aspiration System)
K183185 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Dec 14, 2018
Honda Walking Assist Device
K181294 · PHL
Honda Motor Company, Ltd.
Neurology · 212d
Cleared Dec 10, 2018
reSET-O
K173681 · PWE
Pear Therapeutics, Inc.
Neurology · 374d
Cleared Dec 10, 2018
Route 92 Medical Delivery Catheter
K182512 · DQY
Route 92 Medical, Inc.
Neurology · 89d
Cleared Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
K172897 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 441d
Cleared Dec 04, 2018
Spartan eCoil System
K180653 · HCG
Spartan Micro, Inc.
Neurology · 266d
Cleared Nov 29, 2018
Persyst 14 EEG Review and Analysis Software
K182181 · OMB
Persyst Development Corporation
Neurology · 108d
Cleared Nov 29, 2018
Espire Elbow Pro, Espire Elbow Hybrid
K182757 · GXY
College Park Industries, Inc.
Neurology · 62d
Cleared Nov 27, 2018
gammaCore Sapphire
K182369 · PKR
Electrocore, Inc.
Neurology · 88d
Cleared Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
K172837 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 433d
Cleared Nov 23, 2018
Visor System
K182967 · QAF
Cerebrotech Medical Systems, Inc.
Neurology · 28d