FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
553–576 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 12, 2023
Axoguard HA+ Nerve Protector (AGHA12)
K231708 · JXI
Axogen Corporation
Neurology · 122d
Cleared Oct 11, 2023
Vlab
K230148 · GWL
Dormotech Medical, Ltd.
Neurology · 265d
Cleared Oct 06, 2023
EARP Nerve Cuff Electrode
K230853 · ETN
Nvision Biomedical Technologies, Inc.
Neurology · 192d
Cleared Oct 05, 2023
Heating Tens, FT-615
K232675 · NUH
Hivox Biotek, Inc.
Neurology · 34d
Cleared Sep 21, 2023
QEVO System
K232159 · GWG
Carl Zeiss Meditec, AG
Neurology · 63d
Cleared Sep 20, 2023
Socrates Aspiration System
K223913 · NRY
Scientia Vascular, Inc.
Neurology · 265d
Cleared Sep 19, 2023
Q Distal Access Catheter
K222948 · QJP
Mivi Neuroscience, Inc.
Neurology · 357d
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