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
2497–2520 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 18, 2009
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM,...
K092546 · GXY
Gmdasz Manufacturing Co., Ltd.
Neurology · 121d
Cleared Dec 08, 2009
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
K083371 · GWF
Natus Medical, Inc.
Neurology · 389d
Cleared Dec 08, 2009
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
K091457 · GWF
Nexstim OY
Neurology · 204d
Cleared Dec 07, 2009
E-PULSE
K091875 · BWK
Medevice Corporation
Neurology · 167d
Cleared Dec 07, 2009
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
K092793 · GXY
Bio-Medical Research, Ltd.
Neurology · 87d
Cleared Dec 04, 2009
EMSI GARMENT ELECTRODES
K090889 · GXY
Emsi
Neurology · 248d
Cleared Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395 · JXG
Integra Lifesciences Corp.
Neurology · 106d
Cleared Nov 17, 2009
ROSA SURGICAL DEVICE, MODEL ROSA 1.1
K092239 · HAW
Medtech S.A
Neurology · 117d
Cleared Nov 16, 2009
KRYPTONITE BONE CEMENT
K091382 · GXP
Doctors Research Group, Inc.
Neurology · 189d
Cleared Nov 06, 2009
VIGILANT EEG MONITOR, VIGILANT 2.0
K091963 · OLT
Infinite Biomedical Technologies, LLC
Neurology · 128d
Cleared Oct 23, 2009
AMD 6605 TENS/NMES
K092990 · GZJ
Advantageous Medical Devices, LLC
Neurology · 25d
Cleared Oct 23, 2009
BIS QUATRO SENSOR
K093183 · GXY
Aspect Medical Systems, Inc.
Neurology · 14d
Cleared Oct 21, 2009
NEUROCALM MODEL 1 AND 2
K090866 · GZJ
Neuromed Devices, Inc.
Neurology · 204d
Cleared Oct 16, 2009
IDENTEVENT, VERSION 1.0G
K092039 · OMB
Optima Neuroscience, Inc.
Neurology · 102d
Cleared Oct 16, 2009
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · GXI
Baylis Medical Co., Inc.
Neurology · 73d
Cleared Oct 09, 2009
WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
K090190 · HAW
Nuclemed S.A.
Neurology · 256d
Cleared Oct 08, 2009
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
K092763 · LIH
Well-Life Healthcare Limited
Neurology · 29d
Cleared Sep 30, 2009
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL...
K092666 · HCG
Boston Scientific Corp
Neurology · 30d
Cleared Sep 29, 2009
SYNERGY
K083378 · GWM
Innerspace, Inc.
Neurology · 319d
Cleared Sep 25, 2009
SONOWAND INVITE
K083597 · HAW
Sonowand AS
Neurology · 294d
Cleared Sep 21, 2009
PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054
K090752 · NRY
Penumbra, Inc.
Neurology · 185d
Cleared Sep 18, 2009
MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS
K092562 · HAW
FHC, Inc.
Neurology · 29d
Cleared Sep 11, 2009
UROVAL BRS SYSTEM, MODEL BRS01
K083679 · IKN
Uroval
Neurology · 274d
Cleared Sep 08, 2009
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT,...
K091921 · HCH
Codman & Shurtleff, Inc.
Neurology · 70d