FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
1369–1392 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 12, 2018
OSSDSIGN Cranioplug
K181539 · GXR
Ossdsign AB
Neurology · 123d
Cleared Oct 12, 2018
Penumbra System (Modified 110 Aspiration Tubing)
K182522 · NRY
Penumbra, Inc.
Neurology · 29d
Cleared Oct 11, 2018
NuFACE Trinity
K181008 · NFO
Carol Cole Company Dba Nuface
Neurology · 177d
Cleared Oct 05, 2018
Sense System with IBT Electrodes
K182112 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 60d
Cleared Oct 04, 2018
HYBRID Guidewire
K182337 · MOF
Balt USA, LLC
Neurology · 37d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Oct 01, 2018
StrataMR guider tool
K181622 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Sep 26, 2018
Everyway Wireless TENS & EMS Unit
K181707 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · GZB
Stimwave Technologies Incorporated
Neurology · 159d
Cleared Sep 15, 2018
ThermaCare Quick Therapy TENS
K181102 · NUH
Pfizer, Inc.
Neurology · 142d
Cleared Sep 14, 2018
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K180369 · GXI
Relievant Medsystems
Neurology · 214d
Cleared Sep 13, 2018
TENS device-HeadaTerm, eEspress
K172450 · PCC
Wat Medical Technology (Ningbo) Co.,...
Neurology · 395d
Cleared Sep 13, 2018
SelectFlex 072 Neurovascular Access System
K181000 · DQY
Q'Apel
Neurology · 150d
Cleared Sep 07, 2018
GLOW800
K181537 · IZI
Leica Microsystems (Schweiz) AG
Neurology · 88d
Cleared Sep 06, 2018
Dual output digital therapy massager
K172834 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 352d
Cleared Sep 01, 2018
Cadwell Zenith System
K181466 · GWQ
Cadwell Industries, Inc.
Neurology · 89d
Cleared Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · POL
Medtronic Neurovascular
Neurology · 123d
Cleared Aug 23, 2018
Freespira
K180173 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 213d
Cleared Aug 22, 2018
NIM PAK Needle
K180542 · PDQ
Boston Endo Surgical Tech,
Neurology · 174d
Cleared Aug 17, 2018
Optical Topography System ETG-4100
K172492 · DQA
Hitachi Healthcare Americas
Neurology · 365d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761 · NRY
Penumbra, Inc.
Neurology · 249d
Cleared Aug 17, 2018
BioWaveGO
K180943 · GZJ
Biowave Corporation
Neurology · 129d
Not Cleared Aug 17, 2018
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
DEN170078 · QCI
Brainways , Ltd.
Neurology · 322d
Cleared Aug 14, 2018
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K173620 · OBP
Tonica Elektronik A/S
Neurology · 265d