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
961–984 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
K190703 · GWF
Neurosoft , Ltd.
Neurology · 796d
Cleared May 20, 2021
Quick-20m
K203331 · GWL
Cgx, LLC
Neurology · 189d
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY
Penumbra, Inc.
Neurology · 178d
Cleared May 04, 2021
Rebellion, Phantom Multi-Bite Kerrison Rongeur 
K200768 · HAE
Morpheus AG
Neurology · 405d
Cleared Apr 30, 2021
CereLink ICP Monitor
K210993 · GWM
Integra Lifesciences Production...
Neurology · 28d
Cleared Apr 28, 2021
Plato 17 Microcatheter
K210601 · DQY
Scientia Vascular, LLC
Neurology · 58d
Cleared Apr 27, 2021
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
K191951 · NFO
Avazzia, Inc.
Neurology · 645d
Cleared Apr 27, 2021
STARband, STARlight, St. Louis Band
K203098 · OAN
Orthomerica Products, Inc.
Neurology · 195d
Cleared Apr 23, 2021
Brainsway Deep TMS System
K203735 · OBP
Brainsway , Ltd.
Neurology · 123d
Cleared Apr 23, 2021
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K210996 · NRY
Imperative Care, Inc.
Neurology · 21d
Cleared Apr 20, 2021
Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500...
K203276 · NOY
Biocompatibles UK Ltd (Part of Boston...
Neurology · 165d
Cleared Apr 16, 2021
Brainsway Deep (DTMS) System
K203616 · QMD
Brainsway , Ltd.
Neurology · 127d
Cleared Apr 11, 2021
Velocity Alpha Highspeed Surgical Drill System
K191479 · HBE
Adeor Medical AG
Neurology · 677d
Cleared Apr 09, 2021
hekaDrill
K193630 · HBC
Zethon, Ltd.
Neurology · 470d
Cleared Apr 02, 2021
ClearPath Disposable Introducer
K210251 · GWG
Clearmind Biomedical
Neurology · 63d
Cleared Mar 31, 2021
Longeviti PMMA Static Cranial Implant
K210616 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 30d
Cleared Mar 29, 2021
DORO QR3 Headrest System (Aluminum)
K203505 · HBL
Pro-Med Instruments GmbH
Neurology · 119d
Cleared Mar 29, 2021
REMI
K203827 · OMC
Epitel, Inc.
Neurology · 90d
Cleared Mar 26, 2021
MyCRO Band
K201426 · MVA
Otto Bock Healthcare LP
Neurology · 301d
Cleared Mar 26, 2021
ETD4000
K202725 · LIH
Therasigma, LLC
Neurology · 190d
Cleared Mar 26, 2021
i-ED COIL System
K210638 · HCG
Kaneka Medical America, LLC
Neurology · 23d
Not Cleared Mar 26, 2021
Portable Neuromodulation Stimulator (PoNS)
DEN200050 · QCF
Helius Medical, Inc.
Neurology · 234d
Cleared Mar 25, 2021
Low-frequency Multi-function physiotherapy instrument
K200177 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 426d
Cleared Mar 25, 2021
ANAM Test System
K201376 · POM
Vista Lifesciences, Inc.
Neurology · 303d