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
457–480 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 04, 2024
SignalNED System (Model RE)
K242306 · OMC
Forest Devices, Inc.
Neurology · 30d
Cleared Aug 30, 2024
Unipro (K-UNIPRO-US)
K232441 · GZJ
Tenscare, Ltd.
Neurology · 382d
Cleared CT Aug 30, 2024
Daylight
K233872 · SCP
Big Health, Inc.
Neurology · 267d
Cleared Aug 30, 2024
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
K241518 · OBP
The Magstim Company Limited
Neurology · 93d
Cleared Aug 30, 2024
Talee, Talee PostOp
K241957 · MVA
Invent Medical USA, LLC
Neurology · 58d
Cleared Aug 29, 2024
Target Detachable Coils
K242243 · HCG
Stryker Neurovscular
Neurology · 29d
Cleared Aug 29, 2024
Grass® MR Conditional/CT Cup Electrodes
K242346 · GXY
Natus Manufacturing Limited
Neurology · 22d
Cleared Aug 28, 2024
BT-1000
K232991 · QGL
Bistos Co., Ltd.
Neurology · 341d
Cleared Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
K233801 · GZB
Boston Scientific Neuromodulation
Neurology · 268d
Cleared Aug 23, 2024
VEEGix EEG System
K240593 · OLT
Neuroservo, Inc.
Neurology · 175d
Cleared Aug 21, 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · GZF
Boston Scientific Neuromodulation
Neurology · 376d
Cleared Aug 21, 2024
cCeLL - In vivo
K233391 · GWG
VPIX Medical, Inc.
Neurology · 324d
Cleared Aug 20, 2024
Borvo EVAC System (Ergo)
K241458 · JXG
Borvo Medical, Inc.
Neurology · 89d
Cleared Aug 14, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED,...
K242057 · GXD
Avanos Medical, Inc.
Neurology · 30d
Cleared Aug 12, 2024
Pixie Pulse (SM9068)
K241365 · NUH
Pixie Cup, LLC
Neurology · 90d
Cleared Aug 07, 2024
SofWave System
K241685 · NGX
Sofwave Medical, Ltd.
Neurology · 57d
Cleared Aug 05, 2024
Sleepio®
K233577 · QVO
Big Health, Inc.
Neurology · 272d
Cleared Aug 01, 2024
A Breathing System (ABS)
K233580 · HCC
Deepwell Dtx, Inc.
Neurology · 268d
Cleared Jul 31, 2024
EARP Nerve Cuff Electrode
K241917 · ETN
Retropsoas Technologies, LLC
Neurology · 30d
Cleared Jul 26, 2024
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)
K241883 · HBL
Pro-Med Instruments GmbH
Neurology · 28d
Cleared Jul 22, 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 90d
Cleared Jul 19, 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
K233067 · NUH
Chongqing Rob Linka Science and...
Neurology · 297d
Cleared Jul 18, 2024
CEFALY Connected - OTC, CEFALY Connected - Rx
K234029 · PCC
Cefaly Technology
Neurology · 211d
Cleared Jul 18, 2024
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · GWM
Braincare Desenvolvimento E Inova??o...
Neurology · 115d