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
433–456 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034 · PCB
Medtronic Neurosurgery
Neurology · 105d
Cleared Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · NUH
Well-Life Healthcare Limited
Neurology · 389d
Cleared Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
K240408 · OMB
Epitel, Inc.
Neurology · 251d
Cleared Oct 17, 2024
Zipline Access Catheter
K240711 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Oct 16, 2024
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · MUD
Edwards Lifesciences
Neurology · 226d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241221 · NRY
Cerenovus, Inc.
Neurology · 168d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241244 · QJP
Cerenovus, Inc.
Neurology · 167d
Cleared Oct 11, 2024
QUEX ED
K232779 · OMC
Qx World, Ltd.
Neurology · 396d
Cleared Oct 08, 2024
Nerivio
K241756 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 112d
Cleared Oct 04, 2024
Zeta Cranial Navigation System (ZNS131-US)
K242351 · HAW
Zeta Surgical, Inc.
Neurology · 57d
Cleared Oct 02, 2024
8F Modified Sheath System
K240529 · QJP
Route 92 Medical, Inc.
Neurology · 222d
Cleared Oct 01, 2024
Esperance 3+ Aspiration Catheter System
K240917 · NRY
Wallaby Medical
Neurology · 181d
Cleared Sep 30, 2024
Numen™ Coil Embolization System
K242154 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 69d
Cleared Sep 27, 2024
encevis (2.1)
K240993 · OMB
Ait Austrian Institute of Technology...
Neurology · 169d
Cleared Sep 27, 2024
Sourcerer
K241513 · OLX
Brain Electrophysiology Laboratory...
Neurology · 121d
Cleared Sep 27, 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · HCG
Balt USA, LLC
Neurology · 28d
Cleared Sep 26, 2024
Permatage Settable Bone Putty
K241027 · GXP
Orthocon, Inc.
Neurology · 164d
Cleared Sep 20, 2024
Traus SSG10 Surgical System
K233153 · HBC
Saeshin Precision Co., Ltd.
Neurology · 359d
Cleared Sep 20, 2024
NeuroField Analysis Suite
K240420 · OLU
Neurofield, Inc.
Neurology · 220d
Cleared Sep 20, 2024
Millipede 088 Access Catheter
K242504 · NRY
Perfuze, Ltd.
Neurology · 29d
Cleared Sep 16, 2024
Traus SSG30 Surgical System
K232938 · HBC
Saeshin Precision Co., Ltd.
Neurology · 362d
Cleared Sep 09, 2024
TENS & EMS Stimulator (MHD-1083)
K241678 · NUH
Shenzhen Minghuangda Electronics Co.,...
Neurology · 90d
Cleared Sep 04, 2024
DreamClear
K240646 · GWL
Somnomed Technologies Inc., Doing...
Neurology · 181d
Cleared Sep 04, 2024
BE Plus PRO, Neurotravel LIGHT
K242305 · GWL
Eb Neuro S.P.A.
Neurology · 30d