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
841–864 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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 CT 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
Cleared Apr 23, 2022
TENS device-EmeTerm 2, Model: YF-ZTY-E2
K220503 · GZJ
Wat Medical Technology, Inc.
Neurology · 60d
Cleared CT Apr 21, 2022
GEMS-H
K213452 · PHL
Samsung Electronics Co., Ltd.
Neurology · 177d
Cleared Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
K213930 · QQC
Brainlab AG
Neurology · 124d
Cleared Apr 19, 2022
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
K220152 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 90d
Cleared Apr 15, 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · NUH
Ningbo Medkinetic Medical Device Co.,...
Neurology · 256d