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
793–816 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jun 08, 2022
EarliPoint System
K213882 · QPF
Earlitec Diagnostics, Inc.
Neurology · 177d
Cleared Jun 06, 2022
Drug Relief v1
K221231 · PZR
Dyansys, Inc.
Neurology · 38d
Cleared Jun 03, 2022
KLS Martin Neuro Rongeurs
K210741 · HAE
KLS-Martin L.P.
Neurology · 448d
Cleared Jun 02, 2022
Minjie Catheter System
K212288 · QJP
Kai Medtech, LLC
Neurology · 316d
Cleared Jun 02, 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K220008 · NCX
Zoll Circulation, Inc.
Neurology · 149d
Cleared Jun 01, 2022
AneuGuide
K213838 · PZO
ArteryFlow Technology Co., Ltd.
Neurology · 174d
Cleared May 31, 2022
Distal Access Catheter
K213065 · QJP
Guangzhou Easycess Medical Co.,Ltd
Neurology · 250d
Cleared May 27, 2022
Benchmark Intracranial Access System
K212838 · QJP
Penumbra, Inc.
Neurology · 262d
Cleared May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K220578 · GZJ
Bozhou Rongjian Medical Appliance...
Neurology · 86d
Cleared May 20, 2022
iovera System
K220656 · GXH
Pacira Biosciences, Inc.
Neurology · 74d
Cleared May 19, 2022
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand...
K220485 · HBC
The Anspach Effort, Inc.
Neurology · 91d
Not Cleared May 18, 2022
Quell-FM
DEN210046 · QSQ
Neurometrix, Inc.
Neurology · 225d
Cleared May 17, 2022
Imperative Care Radial 088 Access System
K220807 · QJP
Imperative Care, Inc.
Neurology · 60d
Cleared May 13, 2022
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull...
K210615 · GZT
Thompson Surgical Instruments, Inc.
Neurology · 438d
Cleared May 12, 2022
ANSiStim-PP
K220397 · NHI
Dyansys, Inc.
Neurology · 90d
Cleared May 11, 2022
Wireless EEG System
K213299 · OLT
Pascall Systems, Inc.
Neurology · 222d
Cleared May 06, 2022
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar...
K212289 · QCI
Neuronetics, Inc.
Neurology · 289d
Cleared May 06, 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788 · NUH
Dongguan Bohuikang Technology Co.,Ltd
Neurology · 151d
Cleared May 06, 2022
Disposable EEG cable
K213884 · GXY
Shenzhen Changke Connect Electronics...
Neurology · 144d
Cleared May 06, 2022
WAVi SCAN EEG System and Accessories
K213900 · GWQ
Wavi Co.
Neurology · 143d
Cleared May 05, 2022
Spartan SC 069
K220716 · DQY
Spartan Micro, Inc.
Neurology · 55d
Cleared May 04, 2022
ROSA ONE Brain application
K214065 · HAW
Medtech S.A.S
Neurology · 128d
Cleared May 02, 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared Apr 25, 2022
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
K213925 · GZI
Myolyn, LLC
Neurology · 130d