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
625–648 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 19, 2023
Millipede 088 Access Catheter
K231802 · QJP
Perfuze, Ltd.
Neurology · 91d
Cleared Sep 18, 2023
BTL-785BNF Handpiece
K232172 · NFO
BTL Industries, Inc.
Neurology · 59d
Cleared Sep 16, 2023
ImPACT Version 4
K231688 · POM
Impact Applications, Inc.
Neurology · 99d
Cleared Sep 15, 2023
Avologi Gel Primer (Model: Av25)
K220735 · GYB
Premier North America, Inc.
Neurology · 550d
Cleared Sep 15, 2023
ClearPoint Array System (Version 1.2)
K232102 · HAW
ClearPoint Neuro, Inc.
Neurology · 63d
Cleared Sep 14, 2023
SOFIA EX Intracranial Support Catheter
K230775 · QJP
MicroVention, Inc.
Neurology · 177d
Cleared Sep 13, 2023
NG Delivery Catheter
K230609 · QJP
Balt USA, LLC
Neurology · 191d
Cleared Sep 13, 2023
Ultimate rTMS
K230735 · OBP
Brain Ultimate, Inc.
Neurology · 181d
Cleared Sep 09, 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software...
K223864 · HAW
Brainlab AG
Neurology · 260d
Cleared Sep 08, 2023
Zeta Cranial Navigation System
K230661 · HAW
Zeta Surgical
Neurology · 182d
Cleared Sep 08, 2023
STarFix Designer Software C0265
K231141 · QRI
FHC, Inc.
Neurology · 140d
Cleared Aug 31, 2023
Q21
K221959 · GWQ
Neurofield, Inc.
Neurology · 422d
Cleared Aug 25, 2023
072 Aspiration System
K222786 · NRY
Q'Apel Medical, Inc.
Neurology · 344d
Cleared Aug 21, 2023
Plato 17 Microcatheter
K223560 · QJP
Scientia Vascular, Inc.
Neurology · 266d
Cleared Aug 18, 2023
Dreem 3S
K223539 · OLZ
Beacon Biosignals, Inc.
Neurology · 268d
Cleared Aug 18, 2023
Onera Sleep Test System (Onera STS)
K223573 · MNR
Onera B.V.
Neurology · 261d
Cleared Aug 18, 2023
Unicare (K-UNICARE-USA)
K231053 · NUH
Tenscare, Ltd.
Neurology · 127d
Cleared Aug 18, 2023
SPARK Scan
K231457 · GWQ
Spark Neuro, Inc.
Neurology · 91d
Cleared Aug 17, 2023
Cadwell Guardian
K230415 · GWF
Cadwell Industries, Inc.
Neurology · 182d
Cleared Aug 16, 2023
SOMNUM (V.1.1.2.)
K223922 · OLZ
Honeynaps Co., Ltd.
Neurology · 229d
Cleared Aug 15, 2023
Route 92 Medical Full Length 054 Access System
K231583 · QJP
Route 92 Medical, Inc.
Neurology · 76d
Cleared Aug 14, 2023
Stryker Resorbable Fixation System
K231208 · HBW
Stryker Leibinger GmbH & Co KG
Neurology · 109d
Cleared Aug 10, 2023
ArtiFascia
K223445 · GXQ
Nurami Medical , Ltd.
Neurology · 269d
Cleared Aug 09, 2023
Conductive carbon film electrode
K231164 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d