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
2449–2472 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 07, 2010
INF 4160 PLUS, MODEL D-FJ31F
K092780 · LIH
Fuji Dynamics Limited
Neurology · 119d
Cleared Jan 06, 2010
MICHIGAN CRANIAL RESHAPING ORTHOSIS
K090341 · MVA
Danmar Products, Inc.
Neurology · 330d
Cleared Dec 23, 2009
SWIFT-LOCK ANCHOR, MODEL 1192
K092371 · GZB
Advanced Neuromodulation Systems
Neurology · 140d
Cleared Dec 22, 2009
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
K091762 · GXY
Covidien
Neurology · 189d
Cleared Dec 18, 2009
SMART TENS, MODEL: D-BC05T
K091045 · GZJ
Body Clock Health Care, Ltd.
Neurology · 249d
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