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
649–672 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 03, 2023
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256 · HAE
Morpheus AG
Neurology · 31d
Cleared Mar 02, 2023
ReWalk P6.0
K221696 · PHL
Re Walk Robotics , Ltd.
Neurology · 265d
Cleared Mar 02, 2023
6F Wallaby Long Sheath
K222603 · DQY
Wallaby Medical, Inc.
Neurology · 185d
Cleared Mar 02, 2023
NEBA® Compact EEG2R Mobile Headset
K223628 · OMC
Neba Health, LLC
Neurology · 87d
Cleared Feb 22, 2023
PATI (Protector Against Tongue Injury)
K221469 · JXL
Neurovice, LLC
Neurology · 278d
Cleared Feb 22, 2023
Disposable Pre-calibrated Brain Biopsy Needle 2.0
K230201 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 28d
Cleared Feb 17, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
K223545 · NRY
Alembic, LLC
Neurology · 84d
Cleared Feb 16, 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker...
K212194 · HAW
Stryker Corporation
Neurology · 582d
Cleared Feb 12, 2023
SMILE
K213629 · QGL
Nu Eyne Co., Ltd.
Neurology · 452d
Cleared Feb 10, 2023
TELIGEN System Peripheral Motor Nerve Stimulation Indications
K223438 · PDQ
Medos International SARL
Neurology · 88d
Cleared Feb 09, 2023
External Drainage System
K221694 · JXG
Jmed(Shenzhen) Technology Limited
Neurology · 244d
Cleared Feb 09, 2023
Okti
K230073 · GWQ
Compumedics Limited
Neurology · 30d
Cleared Feb 06, 2023
Nerivio
K223169 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 118d
Cleared Feb 02, 2023
Polaris Valve Electronic Reading Instrument
K222422 · JXG
Sophysa
Neurology · 175d
Cleared Feb 02, 2023
DeltaScan Patch
K222671 · GXY
Prolira B.V.
Neurology · 149d
Cleared Feb 02, 2023
DeltaScan Monitor
K222680 · NCG
Prolira B.V.
Neurology · 149d
Cleared Feb 01, 2023
Garment Electrodes
K222863 · GXY
Tone-A-Matic International, Inc.
Neurology · 132d
Cleared Feb 01, 2023
Certas Plus Programmable Valves
K223330 · JXG
Integra Lifesciences Production...
Neurology · 93d
Cleared Jan 28, 2023
BrainView QEEG Software
K212684 · OLU
Medeia, Inc.
Neurology · 522d
Cleared Jan 27, 2023
Sim&Size
K222664 · PZO
Sim&Cure
Neurology · 147d
Cleared Jan 26, 2023
Aristotle Colossus Guidewire
K222437 · MOF
Scientia Vascular, Inc.
Neurology · 167d
Cleared Jan 25, 2023
SPRINT Peripheral Nerve Stimulation (PNS) System
K223306 · NHI
Spr Therapeutics, Inc.
Neurology · 90d
Cleared Jan 24, 2023
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · GZJ
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 124d
Cleared Jan 20, 2023
pRESET Thrombectomy Device
K222848 · POL
Phenox Limited
Neurology · 121d