Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Neurology ×
6,334 results
1369–1392 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 02, 2019
Polaris RF Ablation System
K181864 · GXD
Baylis Medical Company, Inc.
Neurology · 174d
Cleared CT 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 CT 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 CT 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
Cleared Nov 21, 2018
PlayMakar Sport Muscle Stimulator, Model PRO-500
K182581 · NUH
Playmakar, Inc.
Neurology · 63d
Cleared Nov 20, 2018
MR Compatible Aspiration Kit
K181731 · GWG
Mri Interventions, Inc.
Neurology · 144d
Cleared Nov 20, 2018
CodMan Certas Plus Programmable Valve
K182265 · JXG
Integra Lifesciences Corp.
Neurology · 91d
Cleared Nov 16, 2018
Serenity Piezo Sensor, Serenity Thermocouple Sensor
K181709 · OLV
Neurotronics, Inc.
Neurology · 141d
Cleared Nov 14, 2018
React 71 Catheter
K182097 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 103d