FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
793–816 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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 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
Cleared Apr 13, 2022
Bendit21 Microcatheter
K203842 · QJP
Bend IT Technologies, Ltd.
Neurology · 468d
Cleared Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
K214025 · KRA
Medos International SARL
Neurology · 111d
Cleared Apr 12, 2022
ClearPoint Array System (version 1.1)
K214040 · HAW
ClearPoint Neuro, Inc.
Neurology · 110d
Cleared Apr 08, 2022
visor2 system
K210109 · HAW
Eemagine Medical Imaging Solutions GmbH
Neurology · 444d
Cleared Apr 06, 2022
Onera Sleep Test System (Onera STS)
K210593 · MNR
Onera B.V.
Neurology · 401d
Cleared Apr 06, 2022
ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
K220625 · OBP
Remed Co., Ltd.
Neurology · 34d
Cleared Apr 01, 2022
TENS and EMS Stimulation (OTC)
K212184 · NUH
Changsha Yuwen Medical Equipment Co.,...
Neurology · 262d
Cleared Apr 01, 2022
TENS & PMS Unit
K220005 · NUH
Shenzhen Yuehua Xinsen Technology...
Neurology · 87d
Cleared Mar 31, 2022
ERIC Retrieval Device
K211120 · NRY
MicroVention, Inc.
Neurology · 350d
Cleared Mar 31, 2022
PediGuard Threaded
K220160 · PDQ
Spineguard S.A.
Neurology · 71d
Not Cleared Mar 29, 2022
BrainTemp Neonate System (BTNeo System)
DEN200042 · QSL
Brain Temp, Inc.
Neurology · 644d
Cleared Mar 24, 2022
FUBUKI XF Neurovascular Long Sheath
K213589 · QJP
Asahi Intecc Co., Ltd.
Neurology · 132d
Cleared Mar 18, 2022
Needle Stimulator (Model: RJNS6-1)
K220153 · BWK
Bozhou Rongjian Medical Appliance...
Neurology · 58d
Cleared Mar 15, 2022
CerusEndo Microcatheter (027)
K213314 · QJP
Cerus Endovascular, Inc.
Neurology · 162d
Cleared Mar 11, 2022
Personal Kinetigraph (PKG) System Gen 2 Plus
K211887 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 263d
Cleared Mar 11, 2022
Intracept Intraosseous Nerve Ablation System
K213836 · GXI
Relievant Medsystems, Inc.
Neurology · 92d
Cleared Mar 09, 2022
SafeOp 2: Neural Informatix System
K213849 · GWF
Alphatec Spine, Inc.
Neurology · 89d